Clinical Evaluation for Batch Consistency of Ad5-nCoV in Chinese Healthy Adults

Study Overview
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Brief Summary
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This is a randomized, double-blind, parallel-controlled, equivalence trial, for evaluation of safety and immunogenicity, and batch-to-batch consistency of a recombinant adenovirus type-5-vectored Covid-19 vaccine Convidecia in one shot schedule in Chinese healthy adults aged 18 years and above. In total 1050 healthy adults will be recruited in this study. Subjects in both cohort will be randomized stratified into two cohort by age(18 59 years and≥60 years) in a 1:1:1 ratio to receive one of three consecutive batches of Convidecia. The primary objective is to test the equivalence of the immune responses to three consecutive manufacturing lots of Convidecia in healthy adults. The secondary objectives were to evaluate the immunogenicity and safety of Convidecia for each lot and the pooled data of three lots)

Official Title
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Safety, Immunogenicity, and Batch Consistency of a Single Dose of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Chinese Healthy Adults Aged 18 Years and Above: a Randomized, Double-blind, Parallel-controlled Clinical Trial

Conditions
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COVID-19

Intervention / Treatment
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* Biological: batch 1 of Ad5-nCoV
* Biological: batch 2 of Ad5-nCoV
* Biological: batch 3 of Ad5-nCoV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy participants aged 18 years and above who have not received COVID-19 vaccine. The subjects can provide with informed consent and sign informed consent form (ICF). 4. The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the follow-up of the study. 5. Axillary temperature ≤ 37.0℃. 6. negative IgM and IgG against SARS-CoV-2 7. with BMI between18.5 to 30.0 8. No history of epidemiological contact with COVID-2019 9. have not been to medium or high risk areas in the past 21 days and have no history of departure. 10. be determined to be healthy by medical history, physical examination and clinical examination and meet the requirements for immunization of this product. Exclusion criteria: Medical history or family history of convulsion, epilepsy, encephalopathy and psychosis. Allergic to any component of the research vaccines, or a history of hypersensitivity or serious reactions to vaccination. Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan in this study. Suffering from acute febrile disease, infectious disease, or SARS infection history Serious cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction, severe hypertension, which cannot be controlled by medication (systolic blood pressure ≥180mmHg, diastolic blood pressure ≥110mmHg) Have severe chronic diseases or unstable condition ( Grade 3 or higher as defined in the guidelines for the classification of adverse events in clinical trials for prophylactic vaccines), Such as diabetes, thyroid disease and so on. Congenital or acquired angioedema / neuroedema. had urticaria one year before this vaccination. Asplenia or functional asplenia. Thrombocytopenia or other clotting disorder (this may contraindicate intramuscular injection). Faintng during acupuncture treatment Received immunosuppressant therapy, antiallergic therapy, cytotoxic therapy, high dose inhaled corticosteroid over the past 6 months (excluding corticosteroid spray for allergic rhinitis, surface corticosteroid for acute non-complicated dermatitis, and corticosteroid with dose less than 20mg/ day) Received blood products within 4 months before vaccination. Received other investigational drugs within 1 month prior to receiving the investigational vaccines. Received other live attenuated vaccines within 1 month prior to receiving the investigational vaccines. Received subunit or inactivated vaccine within 14 days prior to receiving investigational vaccine. Be receiving anti-tuberculosis treatment Have the history of SARS-CoV-2 infection or COVID-19 Any medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the study protocol or affect the subjects' informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects in adults cohort and elderly cohort will be randomized in a 1:1:1 ratio to receive one of three consecutive batches of Convidecia, respectively.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: batch 1 of Ad5-nCoV<br>Eligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202101001. | Biological: batch 1 of Ad5-nCoV<br>* The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202101001. It contains 5×10^10 viral particles per 0.5 mL in a vial.<br>* Other names: Convidecia;|
| Experimental: batch 2 of Ad5-nCoV<br>Eligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202101002. | Biological: batch 2 of Ad5-nCoV<br>* The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202101002. It contains 5×10^10 viral particles per 0.5 mL in a vial.<br>* Other names: Convidecia;|
| Experimental: batch 3 of Ad5-nCoV<br>Eligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202102003. | Biological: batch 3 of Ad5-nCoV<br>* The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202102003. It contains 5×10^10 viral particles per 0.5 mL in a vial.<br>* Other names: Convidecia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination. | GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination. | On day 28 after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMFIs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination. | GMFIs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination. | On day 28 after vaccination | 
| Propotion of participants with at least four-fold increase of post-vaccination antibody level against SARS-CoV-2 RBD-specific binding IgG compared to that at baseline on day 28 after vaccination. | Propotion of participants with at least four-fold increase of post-vaccination antibody level against SARS-CoV-2 RBD-specific binding IgG compared to that at baseline on day 28 after vaccination. | On day 28 after vaccination | 
| GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination stratified by neutralizing antibody levels against Ad5 at baseline. | GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination stratified by neutralizing antibody | On day 28 after vaccination | 
| Incidence of solicited adverse events within 7 days after vaccination. | Incidence of solicited adverse events within 7 days after vaccination. | Within 7 days after vaccination | 
| Incidence of adverse reactions within 28 days after vaccination. | Incidence of adverse reactions within 28 days after vaccination. | Within 28 days after vaccination | 
| Incidence of unsolicited adverse events within 28 days after vaccination. | Incidence of unsolicited adverse events within 28 days after vaccination. | Within 28 days after vaccination | 
| Incidence of serious adverse events (SAE) within the 6 months after vaccination. | Incidence of serious adverse events (SAE) within the 6 months after vaccination. | Within the 6 months after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2 Vaccine, Batches consistency, Adenovirus type-5-vectored, Safety, Immunogenicity