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Completed

NCT Number: NCT04811664

A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine

The purpose of this study is to assess SARS CoV-2 infection, viral shedding, and subsequent potential transmission in individuals immunized with the Moderna COVID-19 vaccine.

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Key information

Conditions

Sars-CoV-2 Infection 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–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alabama CRS, Birmingham, Alabama, United States

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About this study

This study will evaluate the efficacy of the Moderna COVID-19 vaccine against SARS-CoV-2 infection, as well as its effect on peak nasal viral load as a measure of infection and a proxy of infectiousness, in adults aged 18-29.

In the Main study, up to 12,000 participants will be randomized 1:1 to Immediate Vaccination Group 1 (at Months 0 and 1) or Standard of Care Group 2, with vaccination given at Months 4 and 5 if not received off-study previously. Up to an additional 6,000 participants will be enrolled into the Vaccine Declined Group 3 and will also be offered vaccine at Months 4 and 5.

Additional study visits for Group 1 will occur at Months 2 and 4; for Groups 2 and 3, at Months 0 and 2. Study visits may include medical history, vaccine injections, blood collection, nasal swab, SARS-CoV-2 screening, COVID-19 symptom check, and questionnaires.

In addition to the main study participants, the study will also evaluate infectiousness following close contacts with main study participants. Study procedures for close contacts include questionnaires and blood samples; for those who become SARS-CoV-2 infected, study procedures will also include nasal swabs.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for Main cohort, Vaccine Declined Group General and Demographic Criteria

  • Age of 18 through 29 years.
  • Ability and willingness to provide informed consent.
  • Prefers not to receive COVID-19 vaccine.
  • Willingness to be followed for the planned duration of the study.
  • Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire with demonstration of understanding of all questionnaire items answered incorrectly.
  • Access to device and internet for completion of study procedures.

Exclusion criteria

for Main cohort, Vaccine Declined Group

  • Prior administration of a coronavirus (SARS-CoV-2, SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19 (participation in studies of other investigational research agents allowed).
  • Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, or a volunteer's ability to give informed consent.

Inclusion criteria

for Prospective Close Contact (PCC) cohort

  • Age of 18 years or older, at the time of signing the informed consent.
  • Willing and able to provide informed consent.
  • Expected to be in frequent close physical proximity with Main Cohort participant during the study.
  • Willing to share results of SARS-CoV-2 testing.
  • Access to device and internet for completion of study procedures

Inclusion criteria

for Case-ascertained Close Contact (CACC) cohort

  • Age of 18 years or older, at the time of signing the informed consent.
  • Willing and able to provide informed consent.
  • Access to device and internet for completion of study procedures.
  • Willing to share results of SARS-CoV-2 testing.
  • Had close contact with Main Cohort participant with known PCR-confirmed SARS-CoV-2 infection (eg, index case). Close contacts will have had exposure to the index participant, generally within 72 hours of an index diagnosis, and may include individuals that meet any of the following guidelines:

Prolonged close physical proximity with Main Cohort participant within a residence/vehicle/enclosed space without maintaining social distance,

Medical staff, first responders, or other care persons who cared for the index case without appropriate personal protective equipment.

Further information on the definition of close contact can be found in the CoVPN 3006 Study Specific Procedures (SSP).

Treatment and study plan

Moderna COVID-19 Vaccine

Biological

A lipid nanoparticle (LNP) dispersion of a messenger ribonucleic acid (mRNA) encoding the prefusion stabilized S protein of SARS-CoV-2 formulated in LNPs composed of 4 lipids (1 proprietary and 3 commercially available). It is a suspension for intramuscular injection administered as a series of two doses (0.5 mL each) 1 month apart.

Other names: mRNA-1273

Primary outcomes

  1. Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection

    Time frame: Measured through Month 4 study visit

    Incidence of SARS-CoV-2 infection diagnosed by study PCR among baseline negative participants, with exposure starting from first study PCR and censored at last PCR/outside vaccination and exposure period for the Immediate arm additionally limited to period after the second vaccine dose (period unrestricted for Standard of Care and Vaccine Declined arms: by definition corresponds to unvaccinated exposure). Exact confidence interval.

  2. Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load

    Time frame: Measured through Month 4 study visit

    As a measure of infection and a proxy of infectiousness, mean observed peak viral load (minimum cycle threshold) in nasal samples from FAS-P participants diagnosed with SARS-CoV-2 infection, stratified by lab and target (nucleocapsid gene N1 or N2). Nasal swabs were to be collected daily, and viral load was measured on available specimens taken between the first and last days of PCR-confirmed SARS-CoV-2 infection. Due to early termination, the study was underpowered to look at the vaccine effect on viral load and limited descriptive analysis was performed. The number participants analyzed per row is less than the overall number analyzed as participants were only analyzed by one of the two labs and in few cases the N2 target values could not be measured.

  3. Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load

    Time frame: Measured through Month 4 study visit

    As a measure of infection and a proxy of infectiousness, median observed peak viral load (minimum cycle threshold) in nasal samples from FAS-P participants diagnosed with SARS-CoV-2 infection, stratified by lab and target (nucleocapsid gene N1 or N2). Nasal swabs were to be collected daily, and viral load was measured on available specimens taken between the first and last days of PCR-confirmed SARS-CoV-2 infection. Due to early termination, the study was underpowered to look at the vaccine effect on viral load and limited descriptive analysis was performed. The number participants analyzed per row is less than the overall number analyzed as participants were only analyzed by one of the two labs and in few cases the N2 target values could not be measured.

Secondary outcomes

  1. Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms

    Time frame: Measured through Month 4 study visit

    Incidence of study PCR-confirmed SARS-CoV-2 infection and concurrent symptoms captured by daily or weekly symptom reporting (at least one of the following: hospitalization, fever, chills, cough, shortness of breath, difficulty breathing, tiredness/fatigue, muscle aches, joint aches, body aches, headache, change in sense of taste, change in sense of smell, sore throat, nasal congestion, runny nose, nausea, vomiting, diarrhea, oral ulcers and clinical or radiographical evidence of pneumonia) among baseline negative participants. Exposure starting from first study PCR and censored at last PCR/outside vaccination. Participants without concurrent symptom data were assumed not symptomatic and were additionally censored at SARS-CoV-2 infection. Exposure period for the Immediate arm additionally limited to period after the second vaccine dose (period unrestricted for Standard of Care and Vaccine Declined arms: by definition corresponds to unvaccinated exposure). Exact confidence interval.

  2. Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection Regardless of Baseline Negativity

    Time frame: Measured through Month 4 study visit

    Incidence of SARS-CoV-2 infection diagnosed by study PCR among FAS-P participants, with exposure starting from first study PCR and censored at last PCR/outside vaccination and exposure period for the Immediate arm additionally limited to period after the second vaccine dose (period unrestricted for Standard of Care and Vaccine Declined arms: by definition corresponds to unvaccinated exposure). Exact confidence interval.

  3. Impact of Moderna COVID-19 Vaccine on Secondary Transmission of SARS-CoV-2 Infection

    Time frame: Measured through Month 4 study visit

    Evaluated by the number of secondary transmission events in close-contact cohorts from main study participants who were SARS-CoV-2 seronegative at enrollment

  4. Efficacy of Moderna COVID-19 Vaccine to Prevent Serologically Confirmed SARS-CoV-2 Infection

    Time frame: Measured through Month 4 study visit

    Evaluated by SARS-CoV-2 antibodies to the nucleocapsid protein post Month 1 visit among participants who were SARS-CoV-2 seronegative at enrollment

  5. Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms

    Time frame: Measured through Month 4 study visit

    Evaluated by SARS-CoV-2 infection confirmed by PCR among participants who were SARS-CoV-2 seronegative at enrollment; reporting at least 2 of the following systemic symptoms: Fever (≥ 38ºC), chills, myalgia, headache, sore throat; or reporting at least one of the following signs/symptoms: cough, shortness of breath or difficulty breathing, new olfactory or taste disorder, clinical or radiographical evidence of pneumonia, thromboembolic event, myocardial infarction, myocarditis, chilblains, or multi-inflammatory syndrome

  6. Effect of Moderna COVID-19 Vaccine on Magnitude of Viral Load Over Time

    Time frame: Measured through Month 4 study visit

    Summary measures of the viral load curve, all evaluated among participants diagnosed with SARS-CoV-2 infection who were SARS-CoV-2 seronegative at enrollment

  7. Efficacy of Moderna Vaccine Regardless of Baseline Serostatus (SARS-CoV-2 Infection by PCR)

    Time frame: Measured through Month 4 study visit

    Evaluated by SARS-CoV-2 infection diagnosed by PCR

  8. Effect of Moderna Vaccine on Viral Load Regardless of Baseline Serostatus (Viral Load)

    Time frame: Measured through Month 4 study visit

    Evaluated by peak viral load in nasal samples from diagnosed participants

  9. Effect of Moderna Vaccine on Secondary Status Regardless of Baseline Serostatus (Secondary Transmission Events)

    Time frame: Measured through Month 4 study visit

    Evaluated by number of secondary transmission events in close-contact cohorts

  10. Immunogenicity of Moderna COVID-19 Vaccine

    Time frame: Measured through Month 2

    Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays

  11. Immune Responses as Correlates of Risk of SARS-CoV-2 Acquisition, Viral Load, Secondary Infection, and COVID-19 Disease

    Time frame: Measured through Month 2

    Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays

  12. Efficacy of Moderna COVID-19 Vaccine Against Asymptomatic SARS-CoV-2 Infection

    Time frame: Measured through Month 4 study visit

    SARS-CoV-2 infection by PCR or periodic serology

  13. Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection and COVID-19 Disease

    Time frame: Measured through Month 4 study visit

    SARS-CoV-2 infection diagnosed by PCR among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits

  14. Effect of Moderna COVID-19 Vaccine on Viral Load

    Time frame: Measured through Month 4 study visit

    Measure of peak viral load among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits

  15. Effect of Moderna COVID-19 Vaccine on Secondary Transmission

    Time frame: Measured through Month 4 study visit

    Measure of secondary transmission events among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

A Randomized Controlled Study to Assess SARS CoV-2 Infection, Viral Shedding, and Subsequent Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine

Acronym: CoVPN 3006

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2021
Registry last updated
Aug 2, 2023

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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