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Completed

NCT Number: NCT05303584

Heterologous Boost Immunization with Ad5-nCoV After Three-dose Priming with an Inactivated SARS-CoV-2 Vaccine

This is an open-label, randomized, parallel-controlled clinical trial to evaluate the safety and immunogenicity of heterologous prime-boost immunization with an aerosolized (Ad5-nCoV-IH) or intramuscular (Ad5-nCoV-IM) Ad5-nCoV after three-dose priming with an inactivated COVID-19 vaccine (CoronaVac) in adults aged 18 years and above. A total of 360 subjects will be included. Approximately 210 subjects who have completed three doses of CoronaVac more than 6 months ago in the prior clinical trial and other 150 eligible subjects will be recruited and randomized respectively in a ratio of 1:1:1 to receive a booster dose of Ad5-nCoV-IH or Ad5-nCoV-IM or ICV. The occurrence of adverse reactions within 28 days and serious adverse events within 6 months after vaccination will be observed in all participants. In addition, blood and saliva samples will be collected from all participants on the day 0 before and 14, 28 days and 3, 6 months after the booster vaccination. Each subject will remain in this study for approximately 6 months.

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Key information

Conditions

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 4

Primary location

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Health subjects aged ≥18 years
  • The subject can provide with informed consent and sign informed consent form (ICF).
  • The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 6-month follow-up of the study.
  • Participants who have received three-dose of inactivated SARS-CoV-2 vaccine more than 6 months ago.

Exclusion criteria

  • Have the medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
  • Be allergic to any component of the research vaccines, or used to have a history of hypersensitivity or serious reactions to vaccination.
  • Vaccine-related SAE occurred after previous vaccination with COVID-19 vaccine.
  • Women with positive urine pregnancy test or in lactation.
  • Have acute febrile diseases or infectious diseases or have a history of SARS.
  • Axillary temperature>37.0℃
  • Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg when measured in the field)
  • Have severe chronic diseases or condition is not stable, such as asthma, diabetes, thyroid disease
  • Congenital or acquired angioedema / neuroedema.
  • Have the history of urticaria 1 year before.
  • Have asplenia or functional asplenia.
  • Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities.
  • Have history of SARS-CoV-2 infection or COVID-19.
  • Have symptoms of upper respiratory tract infection.
  • Have traveled to medium or high risk areas or traveled abroad in the past 21 days, and epidemiologically contacted with SARS-CoV-2.
  • Any medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's informed consent.

Treatment and study plan

Ad5-nCoV-IH

Biological

The orally aerosolized Ad5-nCoV is a replication defective Ad5 vectored COVID-19 vaccine expressing the full-length spike gene of wide-type SARS-CoV-2, Wuhan-Hu-1. The Ad5-nCoV vaccine was supplied in 1.5mL/vial, at a concentration of 1.0 × 1011 viral particles per mL as a liquid formulation. 0.1 ml of Ad5-nCoV vaccine will be aerosolized by using Continuous Vapouring System. Then, the aerosolized droplets will be poured into a disposable suction cup and be inhaled by participants through mouth.

Other names: aerosolized Ad5-nCoV, Convidecia

Ad5-nCoV-IM

Biological

The Ad5-nCoV is a replication defective Ad5 vectored COVID-19 vaccine expressing the full-length spike gene of wide-type SARS-CoV-2, Wuhan-Hu-1. It was supplied in 1·5mL/vial, at a concentration of 1.0 × 1011 viral particles per mL as a liquid formulation. Participants will be administrated 0.5ml（5×1010VP）of Ad5-nCoV vaccine intramuscularly.

Other names: intramuscular Ad5-nCoV

CoronaVac

Biological

CoronaVac is an inactivated whole-virion vaccine with aluminium hydroxide as the adjuvant, prepared with a novel coronavirus (CZ02 strain) inoculated in African green monkey kidney cells (Vero cells). One dose of CoronaVac contains 3 μg of SARS-CoV-2 virion in a 0.5 mL aqueous suspension for injection with 0.45 mg/mL of aluminium.

Primary outcomes

  1. Incidence of adverse reactions within 28 days after the booster dose

    Time frame: Within 28 days the booster dose

    Incidence of adverse reactions within 28 days after the booster dose.

  2. GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.

    Time frame: On day 28 after the booster dose

    GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.

Secondary outcomes

  1. Geometric Mean Fold Increase (GMI) and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.

    Time frame: On day 28 after the boost vaccination

    GMI and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.

  2. GMT, GMI and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14, month 3 and 6 after the booster dose.

    Time frame: On day 14, month 3 and 6 after the booster dose

    GMT, GMI and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus as compared to baseline on day 14, month 3 and 6 after the booster dose.

  3. Geometric mean concentration (GMC), GMI and seroconversion of anti-SARS-CoV-2 NP-specific, RBD-specific and NTD-specific IgG measured by ELISA on day 14, day 28 and month 3 and 6 after the booster dose.

    Time frame: On day 14, day 28 and month 3 and 6 after the booster dose

    Geometric mean concentration (GMC), GMI and seroconversion of anti-SARS-CoV-2 NP-specific, RBD-specific and NTD-specific IgG measured by ELISA on day 14, day 28 and month 3 and 6 after the booster dose.

  4. Incidence of adverse reactions within 30 minutes after the booster dose.

    Time frame: Within 30 minutes after the booster dose

    Incidence of adverse reactions within 30 minutes after the booster dose.

  5. Incidence of adverse reactions within 14 days after the booster dose.

    Time frame: Within 14 days after the booster dose

    Incidence of adverse reactions within 14 days after the booster dose.

  6. Incidence of adverse events within 28 days after the booster dose.

    Time frame: Within 28 days after the booster dose

    Incidence of adverse events within 28 days after the booster dose.

  7. Incidence of serious adverse events (SAE) until 6 months after the booster dose.

    Time frame: Within 6 months after the booster dose

    Incidence of SAE until 6 months after booster vaccination.

Other outcomes

  1. GMT, GMI and seroconversion of neutralizing antibodies against VOC/VOI of SARS-CoV-2 virus on day 28 after the booster dose.

    Time frame: On day 28 after the booster dose

    GMT, GMI and seroconversion of neutralizing antibodies against VOC/VOI of SARS-CoV-2 virus on day 28 after the booster dose.

  2. The levels of IFN-γ、TNF-α、IL-2 secreted by specific T cells stimulated with a peptide pool covering the full-length spike glycoprotein on day 14 after the booster vaccination.

    Time frame: On day 14 after the booster vaccination

    The levels of IFN-γ、TNF-α、IL-2 secreted by specific T cells stimulated with a peptide pool covering the full-length spike glycoprotein on day 14 after the booster vaccination.

  3. The levels of anti-SARS-CoV-2 RBD-specific binding IgA in saliva on day 14, day 28 and month 3 and 6 after the booster dose.

    Time frame: On day 28 after the booster dose

    The levels of anti-SARS-CoV-2 RBD-specific binding IgA in saliva on day 14, day 28 and month 3 and 6 after the booster dose.

  4. GMT and GMI of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose stratified by age (aged 18-59 years and over 60 years).

    Time frame: On day 28 after the booster dose

    GMT and GMI of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose stratified by age (aged 18-59 years and over 60 years).

  5. The levels of anti-SARS-CoV-2 N protein binding IgG on day 14 after the booster dose.

    Time frame: On day 14 after the booster dose

    The levels of anti-SARS-CoV-2 N protein binding IgG on day 14 after the booster dose.

  6. The GMT of neutralizing antibodies against the Ad5 before vaccination and any exploratory analyses of other indicators stratified by pre-existing anti-Ad5 NAb titres at baseline（>1:200，≤1:200）

    Time frame: On day 0 before the booster dose

    The GMT of neutralizing antibodies against the Ad5 before vaccination and any exploratory analyses of other indicators stratified by pre-existing anti-Ad5 NAb titres at baseline（>1:200，≤1:200）

Sponsors and collaborators

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention

Network

Registry information

Official study title

Immunogenicity and Safety of the Heterologous Prime-boost Immunization with an Adenovirus Type-5 Vector-based COVID-19 Vaccine (Ad5-nCoV) After Three-dose Priming with an Inactivated COVID-19 Vaccine in Adults Aged 18 Years and Above: a Randomized, Open-label, Parallel-controlled Clinical Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 31, 2022
Registry last updated
Feb 21, 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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