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<p>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% (<i>p</i> &lt; 0.001) with non-significant interaction by sex (RR = 1.549, <i>p</i> = 0.413). Females showed a higher carriage rate than males (28% vs. 19%, <i>p</i> = 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, <i>p</i> = 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, <i>p</i> = 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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月26日

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  • Evaristar Kudowa,
  • Godwin Tembo,
  • Anthony E. Chirwa,
  • Tarsizio Chikaonda,
  • Alfred Muyaya,
  • Lumbani Makhaza,
  • Edna Nsomba,
  • Bridgette Galafa,
  • Faith Thole,
  • John Ndaferankhande,
  • Lorensio Chimgoneko,
  • Neema Toto,
  • Dingase Dula,
  • Ben Morton,
  • Shaun H. Pennington,
  • Angela Hyder-Wright,
  • Andrea M. Collins,
  • Elena Mitsi,
  • Daniela M. Ferreira,
  • Stephen B. Gordon,
  • Marc Y. R. Henrion,
  • Mark Alderson,
  • Sandra Antoine,
  • Christopher R. Bailey,
  • Debbie Bogaert,
  • Jeremy Brown,
  • Sarah Burr,
  • Marien L. De Jonge,
  • Klara Doherty,
  • David Goldblatt,
  • Joel Gondwe,
  • Kate Gooding,
  • Jonathan Grigg,
  • Tina Harawa,
  • Rob Heyderman,
  • Jason Hinds,
  • Simon Jochems,
  • Blessings Kapumba,
  • Vella Kaudzu,
  • Robert Kneller,
  • Richard Malley,
  • Jane Mallewa,
  • Lucinda Manda-Taylor,
  • Edward Mangani,
  • Mphatso Mayuni,
  • Henry Mwandumba,
  • Brian Ngwira,
  • Percy Mwenechanya,
  • Mike Parker,
  • Andrew Pollard,
  • Modesta Reuben,
  • Gabriela Gomes,
  • Jeffrey Weiser,
  • Kondwani Jambo,
  • Tinashe Kenny-Nyazika,
  • Maureen Mkutumula,
  • Maurice Chipwete,
  • Christopher Bailey,
  • Bernard Beall,
  • Stephen Bentley,
  • Debby Bogaert,
  • Joe De Campo,
  • Stuart Clarke,
  • David Cleary,
  • Adam Finn,
  • Brad Gessner,
  • Stephen Gordon,
  • Caz Hales,
  • Melanie Hamon,
  • Robert Heyderman,
  • Kondwani Jambo,
  • Hiroshi Kiyono,
  • Samuel Leong,
  • Marc Lipsitch,
  • Alex Mann,
  • Michael Mina,
  • Eliane Miyaji,
  • Helder Nakaya,
  • Giorgio Napolitani,
  • Daniel Neill,
  • Mihai Netea,
  • Marco Oggioni,
  • Peter Openshaw,
  • Fernanda Peterson,
  • Sue Plummer,
  • Brenda Kwambana,
  • Adam Roberts,
  • Imran Saleem,
  • Andreas Schlitzer,
  • Alex Shalek,
  • Timothy Tobery,
  • John Tregoning,
  • Jeffrey Weiser

摘要

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.