Mix and Match Heterologous Prime-Boost Study Using Approved COVID-19 Vaccines

Phase 2 Unknown 360 enrolled International Vaccine Institute Harvard University · collab Heidelberg University · collab Instituto Nacional de Saúde, Mozambique · collab International Centre for Diarrhoeal Disease Research, Bangladesh · collab The Coalition for Epidemic Preparedness Innovations (CEPI) · collab University of Antananarivo · collab

RandomizedParallel-groupSingle-blindPrevention

Summary

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.

Timeline

Start: 2021-12-29
Primary completion: 2022-09-26
Completion: 2024-02-28

Outcome

Mixed primary results

paper The noninferiority criterion was met only in arm A1 versus A2. PMID 40694514 ↗

paper The non-inferiority margin was 0.67 fold difference in geometric mean ratio (GMR) PMID 40694514 ↗

paper with an adjusted GMR of 0.8 (2-sided 95% CI: .5-1.2). PMID 40694514 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ad26.COV2.S	Vaccine	5e+10 unknown	Intramuscular
Subject	BBIBP-CorV	Vaccine	4 ug	Intramuscular