Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025
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.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04998240 (A Phase 2, Observer-blind, Randomized Study to Assess the Safety and Immunogenicity of Heterologous Prime-boost COVID-19 Vaccines Regimens in Individuals Aged 18 to 65 Years in Mozambique and Madagascar.), which is not on this map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2, Observer-blind, Randomized Study to Assess the Safety and Immunogenicity of Heterologous Prime-boost COVID-19 Vaccines Regimens in Individuals Aged 18 to 65 Years in Mozambique and Madagascar.
Who cites it
2 citing papers in PubMed.
- Long-term cross-variant Fc-mediated immune responses against SARS-CoV-2 induced by a heterologous adenoviral/inactivated virus prime-boost vaccination strategy.NPJ vaccines · 2026Article
- Overcoming Vaccine Inequities and Research Gaps in Africa: Challenges and Opportunities Identified During the COVID-19 Pandemic.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
Corrections and comments
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Authors and funding
40 authors.
Funding
Abstract
backgroundData on immunogenicity and safety of heterologous prime-boost (HePB) regimens using the BBIBP-CorV and Ad26.COV2.S have not yet been reported in sub-Saharan Africa.
methodsWe conducted a randomized, observer-blinded, non-inferiority trial assessing the immunogenicity and safety of HePB regimens using BBIBP-CorV and Ad26.COV2.S, in adults aged 18-65 years. Participants enrolled, were stratified by baseline severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serostatus, and randomized into four arms in a 1:1:1:1 ratio: A1 (BBIBP-CorV, Ad26.COV2.S), A2 (BBIBP-CorV, BBIBP-CorV), B1 (Ad26.COV2.S, BBIBP-CorV), and B2 (placebo, Ad26.COV2.S), administered at 28-day intervals. Fifteen participants in each arm were randomized separately in the immunology subset at a ratio of 1:1:1:1. Primary endpoints were the geometric mean titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies (nAbs) against SARS-CoV-2 Omicron variant BA.1 and safety at 4 weeks after second vaccination. The non-inferiority margin was 0.67 fold difference in geometric mean ratio (GMR) between the ratio of GMTs in the heterologous versus corresponding homologous arms.
resultsA total of 369 participants were randomized, and 367 of them received at least one dose of vaccine. Participants were between 18 and 65 years of age. Four weeks after second dose, GMT of nAbs in arms A1 and A2 was 802.7 (95% confidence interval [CI]: 635.3-1014.3) and 202.6 (95% CI: 150.8-272.1), respectively, with an adjusted GMR of 4.2 (2-sided 95% CI: 2.9-5.9). GMTs were 603.6 (95% CI: 446.1-816.7) and 725.7 (95% CI: 539.5-976.1) in arms B1 and B2, respectively, with an adjusted GMR of 0.8 (2-sided 95% CI: .5-1.2). Three serious adverse events were reported and none of them were related to the vaccination.
conclusionsThe noninferiority criterion was met only in arm A1 versus A2. HePB regimens were safe and well tolerated. CLINICAL TRIALS REGISTRATION: NCT04998240.
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