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| Name | Class |
|---|---|
| The Coalition for Epidemic Preparedness Innovations (CEPI) | UNKNOWN |
| Instituto Nacional de Saúde, Mozambique | OTHER_GOV |
| University of Antananarivo | UNKNOWN |
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This is an observer-blind, randomized study which aims to assess the immune response and the safety of two different approved vaccines for first and second dose in healthy adults.
This is a phase 2, observer-blind, randomized study to assess the safety and the immunogenicity of heterologous prime-boost COVID-19 vaccines regimens in healthy adults aged 18 to 65 years using two approved vaccines (Sinopharm / CNBG Vaccine (BBIBP-CorV) and Johnson & Johnson Vaccine (Ad26.COV2.S)).
The study will consist of 2 cohorts, one for main immunology endpoints (N=260, 65 per study arm) and one for more detailed immunological assessment (N=100, 25 per study arm). Two doses of vaccine will be administered intramuscularly 4 week apart. All the study participants will be follow-up for 12 months from the administration of first vaccine dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prime BBIBP-CorV, Boost Ad26.COV2.S (A1) | Experimental | The randomized study participants will receive Prime BBIBP-CorV vaccine followed by Booster dose of Ad26.COV2.S vaccine (A1). |
|
| Prime BBIBP-CorV, Boost BBIBP-CorV (A2) | Experimental | The randomized study participants will receive Prime BBIBP-CorV vaccine followed by Booster dose of BBIBP-CorV vaccine (A2). |
|
| Prime Ad26.COV2.S, Boost BBIBP-CorV (B1) | Experimental | The randomized study participants will receive Prime Ad26.COV2.S vaccine followed by Booster dose of BBIBP-CorV vaccine (B1). |
|
| Prime Placebo, Boost Ad26.COV2.S (B2) | Experimental | The randomized study participants will receive Prime Placebo vaccine followed by Booster dose of Ad26.COV2.S (B2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell) | Biological | The Inactivated SARS-CoV-2 vaccine (Vero cell)- BBIBP-CorV manufactured by Beijing Institute of Biological Products (BIBP), China National Biotec Group (CNBG), Sinopharm, Beijing, People's Republic of China Dose formulation: A liquid formulation containing 4μg total protein with aluminum hydroxide adjuvant (0·45 mg/mL) per 0·5 mL (2-dose schedule followed by a booster dose). Mode of Administration: Intramuscular Storage Conditions: 2°C to 8°C |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies | Geometric Mean Titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies using a neutralization assay four weeks after the second dose, in COVID-19 seronegative participants following immunization with heterologous and homologous prime-boost COVID-19 vaccines regimens. | Four Weeks after second dose |
| Incidence of SAEs and AESI observed at any time point during the entire study period | Incidence of SAEs and AESI observed at any time point during the entire study period, among all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens | Till 12 months follow-up visit |
| Incidence of solicited reactions within 7 days (local reactions) and 14 days (systemic reactions) | Incidence of solicited reactions within 7 days (local reactions) and 14 days (systemic reactions) following each vaccination in all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens. | Within 7 days (local reactions) and 14 days (systemic reactions) following each vaccination |
| Incidence of unsolicited adverse events that are within 28 days after each vaccination | Incidence of unsolicited adverse events that are within 28 days after each vaccination in all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens. | Within 28 days after each vaccination |
| Incidence of changes in laboratory safety measures from baseline to day 28 after each vaccination | Incidence of changes in laboratory safety measures from baseline to day 28 after each vaccination, in all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) and Geometric Mean Fold Rise (GMFR) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cellular immune responses against SARS-CoV-2 | Cellular immune responses against SARS-CoV-2 by ELISpot and by Intracellular Cytokine Staining (ICS) (Th1/Th2) at days 0, 14, 28, 42, 56, 196, 364, following immunization with heterologous and homologous prime-boost COVID-19 vaccines regimens, in the participants of immunology cohort. | Till 12 months follow-up visit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florian Marks, PhD | International Vaccine Institute | Principal Investigator |
| Ilesh Jani, PhD | Instituto Nacional de Saúde, Mozambique | Principal Investigator |
| Raphael Rakotozandrindrainy, MD | Madagascar Institute for Vaccine Research (MIVR), University of Antananarivo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madagascar Institute for Vaccine Research (MIVR), University of Antananarivo | Antananarivo | 101 | Madagascar | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40694514 | Derived | Ramgi P, Siribie M, Rakotozandrindrainy N, Bule O, Shrivastava H, Chambule L, Park EL, Fernando C, Boque J, Macuiana R, Razafimanantsoa R, Rakotozandrindrainy N, Razafindrabe TJL, Rakotoarisoa AN, Raminosoa TM, Derandrainy HL, Rakotoson MM, de Silva CSS, Mutombene M, Massinga C, Langa JP, Guarnacci T, Kang SSY, Jo SK, Jeon HJ, Excler JL, Yang Y, Wang S, Sugimoto JD, Yang JS, Shim BS, Binger T, Capitine IU, Aziz AB, Park JY, Kim DR, Rakotozandrindrainy R, Jani IV, Tadesse BT, Marks F. Immunogenicity and Safety of Heterologous Versus Homologous Prime-Boost Regimens With BBIBP-CorV and Ad26.COV2.S COVID-19 Vaccines: A Multicentric, Randomized, Observer-Blinded Non-inferiority Trial in Madagascar and Mozambique. Clin Infect Dis. 2025 Jul 22;80(Supplement_1):S37-S46. doi: 10.1093/cid/ciaf130. |
| Label | URL |
|---|---|
| Description Mozambique COVID-19 Situation | View source |
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| International Centre for Diarrhoeal Disease Research, Bangladesh |
| OTHER |
| Harvard University | OTHER |
| Heidelberg University | OTHER |
The primary analysis of this study will be a non-inferiority comparison between heterologous versus homologous boost arms 4 weeks after second vaccination within each group of the studied COVID-19 vaccines, i.e., the A1 arm (BBIBP-CorV, Ad26.COV2.S) will be compared with the A2 arm (BBIBP-CorV, BBIBP-CorV), and the B1 arm (Ad26.COV2.S, BBIBP-CorV) will be compared with the B2 arm (Placebo, Ad26.COV2.S). All 360 participants will be used for the primary analysis and the secondary analysis.
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This is an observer-blind study. So in this study only the outcome assessors should be blinded namely the clinical staff in charge of the clinical outcomes assessment and the laboratory analysts.
|
| Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein), | Biological | Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein), manufactured by Johnson and Johnson in the United States of America. Dose formulation: One dose (0.5 ml) contains contains 5 x 10 10 virus particles Mode of administration: Intramuscular Storage Conditions: 2°C to 8°C |
|
| Placebo - Normal saline (0.9% sodium chloride solution) | Biological | Placebo - Normal saline (0.9% sodium chloride solution) Dose formulation: Not Applicable Mode of administration: Intramuscular Storage conditions: 15°C to 30°C |
|
| Within 28 days after each vaccination |
| Till 12 months follow-up visit |
| Geometric Mean Titers (GMTs) and Geometric Mean Fold Rise (GMFR) |
| Till 12 months follow-up visit |
| GMTs, GMFR from baseline |
| Till 12 months follow-up visit |
| Genome sequencing of SARS-CoV-2 viruses isolated post prime or booster dose | Genome sequencing of SARS-CoV-2 viruses isolated post prime or boost, after diagnosis of SARS-CoV-2 infection, in all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens | After diagnosis of SARS-CoV-2 infection |
| Profile of vaccine-induced humoral response against SARS-CoV-2 | Profile of vaccine-induced humoral response against SARS-CoV-2 using systems serology at days 0, 14, 28, 42, 56, 196, 364, in study participants of immunology subset cohort, following immunization with heterologous and homologous prime-boost COVID-19 vaccines regimens. | Till 12 months follow-up visit |
| Centro de Investigação e Treino em Saúde da Polana Caniço - Instituto Nacional de Saúde |
| Maputo |
| Mozambique |
| 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 |
|---|---|
| D000090984 | Ad26COVS1 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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