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This is a randomized, observer-blind, placebo-controlled study, for evaluation of safety and immunogenicity of heterologous prime-boost immunization of recombinant COVID-19 vaccine (adenovirus type-5 vector) and RBD-based protein subunit vaccine (ZF2001) against COVID-19 in Chinese healthy population. 120 healthy subjects aged over 18 years of age who have been vaccinated with recombinant adenovirus type-5 vectored vaccine will be recruited in this study. Of them, 60 subjects will be enrolled in the "0-28 days" regimen and other 60 will be enrolled in "0-56 days" regimen. Subjects, 30 of them are 18-59 years old and 30 are 60 years old and above in each regimen will be randomly vaccinated with the second dose of subunit vaccine(ZF2001) against COVID-19 or a commercial influenza vaccine in a ratio of 2:1. They will then be vaccinated with the third dose of ZF2001 on month 4 after the second dose. The occurrence of adverse events within 28 days and serious adverse events within 6 months after the last vaccination will be observed. In addition, blood samples will be collected on day 0 before the second vaccination, day 14, 28 after the second vaccination and day 14, month 6 after third vaccination to test serum antibody levels and to profile the immune cells' subgroups and germlines. Each subject will remain in this study for approximately 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "0-28 days" vaccine group | Experimental | One dose of recombinant Ad5 vectored COVID-19 vaccine on day 0, the second dose of subunit vaccine (ZF2001) against COVID-19 on day 28, and a third of subunit vaccine (ZF2001) against COVID-19 on month 4. |
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| "0-28 days" placebo group | Placebo Comparator | One dose of recombinant Ad5 vectored COVID-19 vaccine on day 0, the second dose of a commercial influenza vaccine on day 28, a third of subunit vaccine (ZF2001) against COVID-19 on month 4. |
|
| "0-56 days" vaccine group | Experimental | One dose of recombinant Ad5 vectored COVID-19 vaccine on day 0, the second dose of subunit vaccine (ZF2001) against COVID-19 on day 56, a third of subunit vaccine (ZF2001) against COVID-19 on month 4. |
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| "0-56 days" placebo group | Placebo Comparator | One dose of recombinant Ad5 vectored COVID-19 vaccine on day 0, the second dose of a commercial influenza vaccine on day 56, a third of subunit vaccine (ZF2001) against COVID-19 on month 4. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant Ad5 vectored COVID-19 vaccine | Biological | This vaccine contains 5×10^10 virus particles of recombinant replication defective human type-5 adenovirus expressing SARS-CoV-2 S protein, which is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.5 ml / bottle. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| GMT of neutralizing antibodies against live SARS-CoV-2 virus at Day 14 after the booster vaccination. | GMT of neutralizing antibodies against live SARS-CoV-2 virus at Day 14 after the booster vaccination. | At Day 14 after the booster vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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 adverse events within 28 days after vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Types of binding antibodies IgG against SARS-CoV-2 S protein at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination. | Types of binding antibodies IgG against SARS-CoV-2 S protein at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination. | at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing-Xin Li, PhD | Jiangsu Provincial Center for Diseases Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Diseases Control and Prevention | Nanjing | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35617368 | Derived | Jin P, Guo X, Chen W, Ma S, Pan H, Dai L, Du P, Wang L, Jin L, Chen Y, Shi F, Liu J, Xu X, Zhang Y, Gao GF, Chen C, Feng J, Li J, Zhu F. Safety and immunogenicity of heterologous boost immunization with an adenovirus type-5-vectored and protein-subunit-based COVID-19 vaccine (Convidecia/ZF2001): A randomized, observer-blinded, placebo-controlled trial. PLoS Med. 2022 May 26;19(5):e1003953. doi: 10.1371/journal.pmed.1003953. eCollection 2022 May. |
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Deidentified individual participant data will be available for request 1 month after the completion of the study
1 month to 1 year after the completion of the study
Researchers who provide a scientifically sound proposal will be allowed access to the individual participant data.These proposals will be reviewed and approved by the sponsor, investigator, and collaborators on the basis of scientific merit. To gain access, data requesters will need to sign a data access agreement.
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| RBD-based protein subunit vaccine (ZF2001) against COVID-19 | Biological | This is a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19, made by using CHO cell, 25μg/dose, produced by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd. |
|
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| trivalent split influenza vaccine | Biological | This vaccine contains 15 μ g H1NI, 15 μ g H3N2 and 15 μ g B-series hemagglutinin, produced by Dalian Aleph Biomedical Co., Ltd.It is a liquid dosage form, 0.5 ml / bottle. |
|
Incidence of adverse events within 28 days after vaccination.
| Within 28 days after vaccination. |
| Incidence of unsolicited AE 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) from the first dose to the 6 months after completing the last dose of vaccination. | Incidence of serious adverse events(SAE) from the first dose to the 6 months after completing the last dose of vaccination. | From the first dose to the 6 months after completing the last dose of vaccination. |
| GMT of binding antibodies against SARS-CoV-2 S and RBD protein measured by ELISA at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination. | GMT of binding antibodies against SARS-CoV-2 S and RBD protein measured by ELISA at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination. | at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination. |
| Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and RBD protein at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination. | Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and RBD protein at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination. | at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination. |
| Fold increase of binding antibodies against SARS-CoV-2 S and RBD protein at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination. | Fold increase of binding antibodies against SARS-CoV-2 S and RBD protein measured by ELISA, as compared to baseline, at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination. | at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination. |
| GMT of neutralizing antibodies against live SARS-CoV-2 virus at day 28 after the second vaccination, and day 14, month 6 after the third vaccination | GMT of neutralizing antibodies against live SARS-CoV-2 virus at day 28 after the second vaccination, and day 14, month 6 after the third vaccination | at day 28 after the second vaccination, and day 14, month 6 after the third vaccination |
| Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2 virus at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination. | Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2 virus, as compared to baseline, at day 28 after the second vaccination, and day 14, month 6 after the third vaccination. | at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination. |
| Fold increase of neutralizing antibodies against live SARS-CoV-2 virus at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination. | Fold increase of neutralizing antibodies against live SARS-CoV-2 virus, as compared to baseline, at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination. | at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination. |
| Cross neutralizing of the antibodies to variants of SARS-CoV-2 measured by pseudovirus neutralization test at Day 28 after the booster vaccination. | Cross neutralizing of the antibodies to variants of SARS-CoV-2 measured by pseudovirus neutralization test at Day 28 after the booster vaccination. | At Day 28 after the booster vaccination. |
| The immune cells' subgroups and germlines at Day 28 after vaccination. | The immune cells', such as B cells and T cells, subgroups and germlines at Day 28 after vaccination. | At Day 28 after vaccination. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000706167 | Ad5-nCoV vaccine |
| C000722364 | ZF2001 COVID-19 vaccine |
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