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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| batch 1 of Ad5-nCoV | Experimental | Eligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202101001. |
|
| batch 2 of Ad5-nCoV | Experimental | Eligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202101002. |
|
| batch 3 of Ad5-nCoV | Experimental | Eligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202102003. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| batch 1 of Ad5-nCoV | Biological | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Fengcai Zhu, MSc | Jiangsu Provincial Center for Diseases Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guanyun Center for Disease Control and Prevention | Lianyungang | Jiangsu | 222000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36048417 | Derived | Li ZP, Shi YF, Hou LH, Jin PF, Ma SH, Pan HX, Zhang JL, Shan YM, Huang HT, Wu SP, Du P, Wang X, Wang LL, Wang RJ, Wang Y, Wang XW, Zhu FC, Li JX. Batch-to-batch consistency trial of an adenovirus type-5 vector-based COVID-19 vaccine in adults aged 18 years and above. Expert Rev Vaccines. 2022 Dec;21(12):1843-1849. doi: 10.1080/14760584.2022.2119133. Epub 2022 Sep 1. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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.
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Participants and investigators will be kept blinded.
|
| batch 2 of Ad5-nCoV | Biological | 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. |
|
|
| batch 3 of Ad5-nCoV | Biological | 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. |
|
|
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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |