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
Overview
- Phase
- Phase 4
- Intervention
- Ad5-nCoV-IH
- Conditions
- COVID-19
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Enrollment
- 362
- Locations
- 1
- Primary Endpoint
- GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Group A
Approximately 70 subjects recruited from the prior clinical trial and newly enrolled 50 subjects will receive a booster dose of aerosolized Ad5-nCoV after three-dose priming with ICV
Intervention: Ad5-nCoV-IH
Group B
Approximately 70 subjects recruited from the prior clinical trial and newly enrolled 50 subjects will receive a booster dose of intramuscular Ad5-nCoV after three-dose priming with CoronaVac
Intervention: Ad5-nCoV-IM
Group C
Approximately 70 subjects recruited from the prior clinical trial and newly enrolled 50 subjects will receive homologous fourth dose of CoronaVac.
Intervention: CoronaVac
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Geometric Mean Fold Increase (GMI) and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.(On day 28 after the boost vaccination)
- Incidence of serious adverse events (SAE) until 6 months after the booster dose.(Within 6 months 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.(On day 14, day 28 and month 3 and 6 after the booster dose)
- Incidence of adverse reactions within 30 minutes after the booster dose.(Within 30 minutes after the booster dose)
- Incidence of adverse events within 28 days after the booster dose.(Within 28 days after the booster dose)
- GMT, GMI and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14, month 3 and 6 after the booster dose.(On day 14, month 3 and 6 after the booster dose)
- Incidence of adverse reactions within 14 days after the booster dose.(Within 14 days after the booster dose)