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| Name | Class |
|---|---|
| G42 Healthcare Research Technology Projects LLC | INDUSTRY |
| Abu Dhabi Health Services Company | OTHER_GOV |
| Wuhan Institute of Biological Products Co., Ltd | INDUSTRY |
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This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above. The participants were randomized into three groups of investigational vaccine 1, investigational vaccine 2 and placebo in a 1:1:1 ratio.2 doses of the investigational vaccine or placebo are inoculated into the deltoid muscle of the either arm according to the vaccination schedule of D0 & D21 (+7 days).According to the immune durability results in Phase I/II study, and cross-neutralization assay results, a third dose (booster dose) generates a better immune response and is estimated to offer better protection, therefore, a booster dose will be given after 3 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Vaccine 1 | Experimental | Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by WIBP according to the immunization schedule of D0 & D21. |
|
| Investigational Vaccine 2 | Experimental | Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by BIBP according to the immunization schedule of D0 & D21. |
|
| Placebo | Placebo Comparator | Participants will receive 2 doses of Placebo according to the immunization schedule of D0 & D21. |
|
| Investigational Vaccine 1b | Experimental | Participants will receive a booster dose of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by WIBP after 3 months following two doses of immunization. |
|
| Investigational Vaccine 2b | Experimental | Participants will receive a booster dose of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by BIBP after 3 months following two doses of immunization. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated SARS-CoV-2 Vaccine (Vero cell) | Biological | The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of COVID-19 cases after two-doses of vaccination | From14 days after the second dose to 6 month after the second dose | |
| The incidence of COVID-19 cases after the booster dose of immunization | From 14 days after the booster dose |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of severe cases of COVID-19 and deaths accompanied by COVID-19 after two-doses of vaccination | From 14 day after the second dose to 6 month after the second dose | |
| The incidence of severe cases of COVID-19 and deaths accompanied by COVID-19 after two-doses of vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| the anti-SARS-CoV-2 neutralizing antibody protective level against COVID-19 | 14 days after 2 doses of vaccination | |
| The occurrence of ADE | From the beginning of the first dose to 12 months after the second immunization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walid A Zaher, MD, MSc,PhD | G42 Healthcare Research Technology Projects LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bahrain International Exhibition & Convention Centre Affiliated to Salymynia Medical Complex S | Sanābis | Bahrain | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36851177 | Derived | Al Kaabi N, Yang Y, Eldin Hussein S, Yang T, Abdalla J, Wang H, Lou Z, Chinese Center For Disease Control And Prevention, Bakkour A, Arafat A, China National Biotec Group Company Limited, Jiang Z, Tian Y, National Engineering Technology Research Center For Combined Vaccines Wuhan Institute Of Biological Products Co Ltd, Beijing Institute Of Biological Products Company Limited, Xiao P, Zaher W, Eltantawy I, Wang C, Xu G, Zhang Y, Yang X. Efficacy and Safety of a Booster Vaccination with Two Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: Results of a Double-Blind, Randomized, Placebo-Controlled, Phase 3 Trial in Abu Dhabi. Vaccines (Basel). 2023 Jan 30;11(2):299. doi: 10.3390/vaccines11020299. | |
| 35464483 |
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| Beijing Institute of Biological Products Co Ltd. |
| INDUSTRY |
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|
| Placebo-b | Placebo Comparator | Participants will receive a booster dose of Placebo after 3 months following two doses of immunization. |
|
| Inactivated SARS-CoV-2 Vaccine (Vero cell) | Biological | The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP |
|
| Placebo | Biological | The placebo of inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP |
|
| From 14 day after the booster dose |
| The incidence of any adverse reactions/events | 28 days after each immunization |
| The incidence of serious adverse events (SAE) | From the beginning of the first dose to 12 months after the second immunization |
| The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody | 14 days after full course of immunization |
| The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody | 14 days after full course of immunization |
| The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody | 14 days after full course of immunization |
| The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody | 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization |
| The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody | 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization |
| The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody | 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization |
| The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody | 14 days, 28 days and 6th month after the booster dose |
| The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody | 14 days, 28 days and 6th month after the booster dose |
| The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody | 14 days, 28 days and 6th month after the booster dose |
| Katameya Medical Center |
| Cairo |
| 11835 |
| Egypt |
| Vacsera health Care facilities , MoH | Cairo | 22311 | Egypt |
| Prince Hamza Hospital | Amman | Jordan |
| Sheikh Khalifa Medical City, SEHA | Abu Dhabi | 51900 | United Arab Emirates |
| Al Qarain Primary Health Care Centre-MOHAP | Sharjah city | 61545 | United Arab Emirates |
| Derived |
| Luan N, Li T, Wang Y, Cao H, Yin X, Lin K, Liu C. Th2-Oriented Immune Serum After SARS-CoV-2 Vaccination Does Not Enhance Infection In Vitro. Front Immunol. 2022 Apr 8;13:882856. doi: 10.3389/fimmu.2022.882856. eCollection 2022. |
| 34037666 | Derived | Al Kaabi N, Zhang Y, Xia S, Yang Y, Al Qahtani MM, Abdulrazzaq N, Al Nusair M, Hassany M, Jawad JS, Abdalla J, Hussein SE, Al Mazrouei SK, Al Karam M, Li X, Yang X, Wang W, Lai B, Chen W, Huang S, Wang Q, Yang T, Liu Y, Ma R, Hussain ZM, Khan T, Saifuddin Fasihuddin M, You W, Xie Z, Zhao Y, Jiang Z, Zhao G, Zhang Y, Mahmoud S, ElTantawy I, Xiao P, Koshy A, Zaher WA, Wang H, Duan K, Pan A, Yang X. Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial. JAMA. 2021 Jul 6;326(1):35-45. doi: 10.1001/jama.2021.8565. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000706269 | SARS-CoV-2 inactivated vaccines |
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