Pooled analysis of PCV13 efficacy from controlled human infection trials in Malawi and the UK

We conducted the first pooled analysis of two randomised controlled vaccine trials on experimental pneumococcal serotype 6B carriage, registered in Malawi (PACTR202008503507113) and the UK (ISRCTN45340436). This post-hoc exploratory study examined the sex-based differences in carriage, vaccine efficacy and vaccine-induced responses. PCV-13 reduced colonisation by 76% (p < 0.001) with non-significant interaction by sex (RR = 1.549, p = 0.413). Females showed a higher carriage rate than males (28% vs. 19%, p = 0.066). Baseline anti-6B Capsular Polysaccharide Immunoglobulin G (IgG) titres were higher in females, significantly in Malawi (2.62 µg/ml vs males 2.05 µg/ml, p = 0.015). Post-vaccination titres did not differ by sex. The pooled fold change in IgG pre-post vaccination, was higher in vaccinated females (5.47 vs 3.30, p = 0.053). This analysis demonstrates the utility and challenges of integrating CHIM data between diverse settings to evaluate vaccine efficacy, describe inter-setting differences, investigate biological and immunological factors influencing protection against pneumococcal carriage and ultimately inform future vaccine development strategies.

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Publication Details

Journal
npj Vaccines
Published
2026-02-26
DOI
https://doi.org/10.1038/s41541-026-01381-4
Primary Topic
Pneumonia and Respiratory Infections
Type
article
Field-Weighted Citation Impact
0.00

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article

Pooled analysis of PCV13 efficacy from controlled human infection trials in Malawi and the UK

Blessings M. Kapumba, Percy Mwenechanya, Tina Harawa, Lucinda Manda‐Taylor et al.
npj Vaccines
Pneumonia and Respiratory Infections
article

Pooled analysis of PCV13 efficacy from controlled human infection trials in Malawi and the UK

Blessings M. Kapumba, Percy Mwenechanya, Tina Harawa, Lucinda Manda‐Taylor, Robert Kneller, Marien de Jonge, Neema Toto, Angela Hyder-Wright, Klara Doherty, Vella Kaudzu, Edna Nsomba, Lumbani Makhaza, Elena Mitsi, Bridgette Galafa, Shaun H. Pennington, Sarah E. Burr, Mark R. Alderson, Jeffrey N. Weiser, Alfred Muyaya, Sandra Antoine, Godwin Tembo, John Ndaferankhande, Lorensio Chimgoneko, Faith Thole, Mphatso Mayuni, M. C. Parker, Jason Hinds, Kate Gooding, Brian Ngwira, Simon Jochems, Evaristar Kudowa, Richard Malley, Andrew Pollard, Stephen B. Gordon, Gabriela Carvalho Gomes, Jane Mallewa, Joel Gondwe, Modesta Reuben, Jonathan Grigg, Ben Morton, David Goldblatt, Edward Mangani, Henry Mwandumba, Debbie Bogaert, Rob Heyderman, Daniela M. Ferreira, On behalf of MARVELS and EHPC consortia, Dingase Dula, Jeremy Brown, Anthony E. Chirwa, Andrea M. Collins, Christopher R. Bailey
article en

Abstract

We conducted the first pooled analysis of two randomised controlled vaccine trials on experimental pneumococcal serotype 6B carriage, registered in Malawi (PACTR202008503507113) and the UK (ISRCTN45340436). This post-hoc exploratory study examined the sex-based differences in carriage, vaccine efficacy and vaccine-induced responses. PCV-13 reduced colonisation by 76% (p < 0.001) with non-significant interaction by sex (RR = 1.549, p = 0.413). Females showed a higher carriage rate than males (28% vs. 19%, p = 0.066). Baseline anti-6B Capsular Polysaccharide Immunoglobulin G (IgG) titres were higher in females, significantly in Malawi (2.62 µg/ml vs males 2.05 µg/ml, p = 0.015). Post-vaccination titres did not differ by sex. The pooled fold change in IgG pre-post vaccination, was higher in vaccinated females (5.47 vs 3.30, p = 0.053). This analysis demonstrates the utility and challenges of integrating CHIM data between diverse settings to evaluate vaccine efficacy, describe inter-setting differences, investigate biological and immunological factors influencing protection against pneumococcal carriage and ultimately inform future vaccine development strategies.

npj Vaccines
Boston Children's Hospital (US), Babraham Institute (GB), Program for Appropriate Technology in Health (US), Harvard University (US), Radboud University Nijmegen (NL), University of Liverpool (GB), St George's, University of London (GB), Queen Mary University of London (GB), University of Strathclyde (GB), Liverpool School of Tropical Medicine (GB), Malawi-Liverpool-Wellcome Trust Clinical Research Programme (MW), Leiden University Medical Center (NL), Kamuzu Central Hospital (MW), Radboud University Medical Center (NL), University of Oxford (GB), London School of Hygiene & Tropical Medicine (GB), Radboud Institute for Molecular Life Sciences (NL), Babraham Bioscience Technologies (United Kingdom) (GB), Centre for Inflammation Research (GB), Wellcome Centre for Ethics and Humanities (GB), Queen Elizabeth Central Hospital (MW), Institute of Infection and Immunity (CA), Kamuzu University of Health Sciences (MW), University College London (GB), New York University (US), University of Pretoria (ZA), The University of Tokyo (JP), University of Edinburgh (GB)
Wellcome Trust, Fundação de Amparo à Pesquisa do Estado de São Paulo, Medical Research Council
Good health and well-being
Openalex Percentile: Top 42%
Pneumonia and Respiratory Infections
DOIOpen Access PDFOpenAlex
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