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OpenTrials
Completed

NCT Number: NCT04436276

A Study of Ad26.COV2.S in Adults (COVID-19)

The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort in healthy adults aged greater than or equal to (>=) 18 to less than or equal to (<=) 55 years and in adults aged >= 65 years in good health with or without stable underlying conditions. The purpose of the study is also to assess the safety and reactogenicity of Ad26.COV2.S administered as ad hoc booster vaccination in healthy adults aged >= 18 to <= 55 years and in adults >= 65 years in good health with or without stable underlying conditions.

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Key information

Conditions

Covid-19 Prevention COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UZA-SGS, Edegem, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose, procedures, and potential risks and benefits of the study, and is willing to participate in the study
  • All female participants of childbearing potential must have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration
  • Participant must have a body mass index (BMI) less than or equal to (<=) 30.0 kilograms per square meter (kg/m^2)
  • Applicable to Cohorts 1 and 2 only: Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, clinical laboratory assessments, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (COVID-19). Applicable to Cohort 3 only: In the investigator's clinical judgment, participant must be either in good or stable health Participants may have underlying illnesses such as hyperlipoproteinemia or hypothyroidism, as long as their symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe COVID-19 (participants may have medical conditions of mild severity (according to the Toxicity Grading Scale), as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, for example, thiazides, Beta blockers, Alpha blockers at the same effective dose).

Exclusion criteria

  • Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
  • Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
  • Participant has a history of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood
  • Participant has a positive diagnostic test result for SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) at screening
  • Participants with comorbidities that are or might be associated with an increased risk of progression to severe COVID-19, that is, participants with moderate-to-severe asthma; chronic lung diseases such as chronic obstructive pulmonary disease (COPD) (including emphysema and chronic bronchitis), idiopathic pulmonary fibrosis and cystic fibrosis; diabetes (including type 1 or type 2); serious heart conditions, including heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and (pulmonary) hypertension or high blood pressure; obesity (BMI >= 30 kg/m^2); chronic liver disease, including cirrhosis; sickle cell disease; thalassemia; cerebrovascular disease; neurologic conditions (dementia); smoking end stage renal disease; organ transplantation; cancer; HIV infection and other immunodeficiencies; hepatitis B infection; and sleep apnea. Applicable to Cohort 3 only: Participants may have hypertension of mild severity (according to the Toxicity Grading Scale), as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, for example, thiazides, Beta blockers, Alpha blockers at the same effective dose)
  • Applicable to Cohorts 1 and 3 only: Participant currently working in an occupation with a high risk of exposure to SARS-CoV-2 (for example, health care worker or emergency response personnel) or considered at the investigator's discretion to be at increased risk to acquire COVID-19 for any other reason

Treatment and study plan

Ad26.COV2.S

Biological

Participants will receive intramuscular (IM) injection of Ad26.COV2.S.

Other names: JNJ-78436735, Ad26COVS1

Placebo

Biological

Participants will receive Placebo.

Primary outcomes

  1. Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

    Time frame: 7 days post-vaccination 1 on Day 1 (Day 8)

    Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohorts 1a and 1b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  2. Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

    Time frame: 7 days after vaccination 2 on Day 57 (Day 64)

    Number of participants with solicited local AEs for 7 days after vaccination 2 in Cohorts 1a and 1b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  3. Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

    Time frame: 7 days after ad hoc booster vaccination (Day 488 up to Day 604)

    Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  4. Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

    Time frame: 7 days after Vaccination 1 on Day 1 (Day 8)

    Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohorts 2a and 2b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  5. Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1

    Time frame: 7 days after booster vaccination 1 on Day 183 (Day 190)

    Number of participants with solicited local AEs for 7 days after booster vaccination 1 in Cohort 2a were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  6. Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2

    Time frame: 7 days after booster vaccination 2 on Day 366 (Day 373)

    Number of participants with solicited local AEs for 7 days after booster vaccination 2 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  7. Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

    Time frame: 7 days after ad hoc booster vaccination (Day 384 up to Day 451)

    Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  8. Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

    Time frame: 7 days after Vaccination 2 on Day 57 (Day 64)

    Number of participants with solicited local AEs for 7 days after Vaccination 2 in Cohort 2b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  9. Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1

    Time frame: 7 days after booster vaccination 1 on Day 239 (Day 246)

    Number of participants with solicited local AEs for 7 days after booster vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  10. Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2

    Time frame: 7 days after booster vaccination 2 on Day 422 (Day 429)

    Number of participants with solicited local AEs for 7 days after booster Vaccination 2 in Cohort 2b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  11. Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

    Time frame: 7 days after ad hoc booster vaccination (Day 369 up to Day 412)

    Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

  12. Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

    Time frame: 7 days after vaccination 1 on Day 1 (Day 8)

    Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  13. Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

    Time frame: 7 days after Vaccination 2 on Day 57 (Day 64)

    Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  14. Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

    Time frame: 7 days after ad hoc booster vaccination (Day 488 up to Day 604)

    Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post Ad Hoc Booster Vaccination (day of Ad hoc booster vaccination and the subsequent 7 days).

  15. Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

    Time frame: 7 days after Vaccination 1 on Day 1 (Day 8)

    Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohorts 2a and 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  16. Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1

    Time frame: 7 days after booster vaccination 1 on Day 183 (Day 190)

    Number of participants with solicited systemic AEs for 7 days post booster vaccination 1 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  17. Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2

    Time frame: 7 days after booster vaccination 2 on Day 366 (Day 373)

    Number of participants with solicited systemic AEs for 7 days after booster vaccination 2 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  18. Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

    Time frame: 7 days after ad hoc booster vaccination (Day 384 up to Day 451)

    Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post adhoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days).

  19. Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

    Time frame: 7 days after Vaccination 2 on Day 57 (Day 64)

    Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  20. Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1

    Time frame: 7 days after booster vaccination 1 on Day 239 (Day 246)

    Number of participants with solicited systemic AEs for 7 days after booster vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  21. Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2

    Time frame: 7 days after booster vaccination 2 on Day 422 (Day 429)

    Number of participants with solicited systemic AEs for 7 days after booster vaccination 2 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  22. Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

    Time frame: 7 days after ad hoc booster vaccination (Day 369 up to Day 412)

    Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post ad hoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days).

  23. Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

    Time frame: 7 days after vaccination 1 on Day 1 (Day 8)

    Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).

  24. Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

    Time frame: 7 days post-vaccination 1 on Day 1 (Day 8)

    Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  25. Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

    Time frame: 7 days post-vaccination 2 on Day 57 (Day 64)

    Number of participants with solicited local AEs for 7 days after vaccination 2 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).

  26. Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

    Time frame: 7 after post-vaccination 2 on Day 57 (Day 64)

    Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

  27. Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

    Time frame: 7 days after ad hoc booster vaccination (Day 456 up to Day 711)

    Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).

  28. Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

    Time frame: 7 days after ad hoc booster vaccination (Day 456 up to Day 711)

    Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post ad hoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days).

  29. Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen

    Time frame: 28 days after vaccination 1 on Day 1 (Day 29)

    Number of participants with unsolicited AEs after vaccination 1 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  30. Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen

    Time frame: 28 days after vaccination 2 on Day 57 (Day 85)

    Number of participants with unsolicited AEs after vaccination 2 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  31. Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination

    Time frame: 28 days after ad hoc booster vaccination (Day 488 up to Day 625)

    Number of participants with unsolicited AEs after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  32. Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen

    Time frame: 28 days after Vaccination 1 on Day 1 (Day 29)

    Number of participants with unsolicited AEs after vaccination 1 in Cohorts 2a and 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  33. Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1

    Time frame: 28 days after booster vaccination 1 on Day 183 (Day 211)

    Number of participants with unsolicited AEs after booster 1 vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  34. Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2

    Time frame: 28 days after booster vaccination 2 on Day 366 (Day 394)

    Number of participants with unsolicited AEs after booster vaccination 2 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  35. Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination

    Time frame: 28 days after ad hoc booster vaccination (Day 384 up to Day 472)

    Number of participants with unsolicited AEs after ad hoc booster vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  36. Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen

    Time frame: 28 days after Vaccination 2 on Day 57 (Day 85)

    Number of participants with unsolicited AEs after vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  37. Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1

    Time frame: 28 days after booster vaccination 1 on Day 239 (Day 267)

    Number of participants with unsolicited AEs 28 days after booster vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  38. Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2

    Time frame: 28 days after booster vaccination 2 on Day 422 (Day 450)

    Number of participants with unsolicited AEs 28 days after booster vaccination 2 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  39. Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination

    Time frame: 28 days after ad hoc booster vaccination (Day 369 up to Day 433)

    Number of participants with unsolicited AEs 28 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  40. Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen

    Time frame: 28 days after vaccination 1 on Day 1 (Day 29)

    Number of participants with unsolicited AEs 28 days after vaccination 1 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  41. Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen

    Time frame: 28 days after vaccination 2 on Day 57 (Day 85)

    Number of participants with unsolicited AEs 28 days after vaccination 2 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  42. Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination

    Time frame: 28 days after ad hoc booster vaccination (Day 456 up to Day 732)

    Number of participants with unsolicited AEs 28 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  43. Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs)

    Time frame: Day 1 up to 2 years after Vaccination 2 on Day 57 (Day 787)

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

  44. Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs)

    Time frame: Day 1 up to 6 months post primary regimen (up to Day 183 for Cohort 2a; up to Day 239 for Cohort 2b)

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

  45. Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs)

    Time frame: Day 1 up to 2 years after Vaccination 2 on Day 57 (Day 787)

    Number of participants with AESIs was reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter.

  46. Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs)

    Time frame: Day 1 up to 6 months post primary regimen (up to Day 183 for Cohort 2a; up to Day 239 for Cohort 2b)

    Number of participants with AESIs was reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter.

Secondary outcomes

  1. Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)

    Time frame: Days 29, 57, 71, 85, 239, and 422

    Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.

  2. Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)

    Time frame: Days 29 and 71

    Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.

  3. Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)

    Time frame: Days 8, 29, 183, 190, 211, 366, 373, and 394,

    Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.

  4. Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)

    Time frame: Days 8, 29, 57, 64, 85, 239, 246, 267 and 422

    Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.

  5. Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)

    Time frame: Days 15, 29, 87, 100, 114 and 268

    Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.

  6. Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA)

    Time frame: Days 29, 57, 71, 85, 239 and 422

    GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported.

  7. Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA)

    Time frame: Days 29, 183, 190, 211, 366, 373 and 394

    GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported.

  8. Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA)

    Time frame: Days 15, 29, 87, 100, 114 and 268

    GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported.

  9. Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2)

    Time frame: Baseline, Days 15, 29, 57, 71, 85, 239 and 422

    Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

  10. Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2)

    Time frame: Baseline, Days 29 and 366

    Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

  11. Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2)

    Time frame: Baseline, Days 29, 57, 85 and 422

    Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

  12. Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2)

    Time frame: Baseline, Days 15, 29, 87, 100, 114 and 268

    Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

  13. Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+

    Time frame: Baseline, Day 15, 29, 57, 71, 85, 239 and 422

    Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

  14. Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+

    Time frame: Baseline, Days 29 and 366

    Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

  15. Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+

    Time frame: Baseline, Days 29, 57, 85 and 422

    Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

  16. Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+

    Time frame: Baseline, Days 15, 29, 87, 100, 114 and 268

    Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

  17. Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+

    Time frame: Baseline, Days 15, 29, 57, 71, 85, 239 and 422

    Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

  18. Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+

    Time frame: Baseline, Days 29 and 366

    Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

  19. Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+

    Time frame: Baseline, Days 29, 57, 85 and 422

    Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

  20. Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+

    Time frame: Baseline, Days 15, 29, 87, 100, 114 and 268

    Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

  21. Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1

    Time frame: Days 15, 29, 57, 71, 85, 239 and 422

    Percentage of participants with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio >=1 and <1 was reported.

  22. Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1

    Time frame: Days 29 and 366

    Percentage of participants with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio >=1 and <1 was reported.

  23. Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1

    Time frame: Days 29, 57, 85 and 422

    Percentage of participants with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio >=1 and <1 was reported.

  24. Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1

    Time frame: Days 15, 29, 87, 100, 114 and 268

    Percentage of participant with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio >=1 and <1 was reported.

Sponsors and collaborators

Lead sponsor

Janssen Vaccines & Prevention B.V.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26COVS1 in Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2020
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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