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

Kudowa, E, Tembo, G, Chirwa, AE, Chikaonda, T, Muyaya, A, Makhaza, L, Nsomba, E, Galafa, B, Thole, F, Ndaferankhande, J, Chimgoneko, L, Toto, N, Dula, D, Morton, B, Pennington, SH, Hyder-Wright, A, Collins, AM, Mitsi, E, Ferreira, DM, Gordon, SB et al (2026) Pooled analysis of PCV13 efficacy from controlled human infection trials in Malawi and the UK. Npj Vaccines, 11 (1). ISSN 2059-0105

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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.

Item Type:	Article
Uncontrolled Keywords:	MARVELS; EHPC consortia; 3207 Medical Microbiology; 32 Biomedical and Clinical Sciences; Prevention; Biotechnology; Vaccine Related; Pneumonia & Influenza; Biodefense; Immunization; Women's Health; Infectious Diseases; 3.4 Vaccines; Infection; 3 Good Health and Well Being; 3204 Immunology; 3207 Medical microbiology
Subjects:	R Medicine > RA Public aspects of medicine R Medicine > RM Therapeutics. Pharmacology
Divisions:	Pharmacy and Biomolecular Sciences
Publisher:	Springer Nature
Date of acceptance:	16 January 2026
Date of first compliant Open Access:	3 June 2026
Date Deposited:	03 Jun 2026 12:34
Last Modified:	03 Jun 2026 12:34
DOI or ID number:	10.1038/s41541-026-01381-4
URI:	https://researchonline.ljmu.ac.uk/id/eprint/28714

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