Safety and Immunogenicity of Anti-Pneumococcal Vaccines in HIV-Infected Pregnant Women

Summary

The purpose of this study was to determine the safety, reactogenicity, immunogenicity, transplacental antibody transfer and interference with infant responses to childhood vaccination of maternal vaccination with pneumococcal conjugate 10-valent vaccine (PCV-10) or pneumococcal polysaccharide 23-valent vaccine (PPV-23) by comparison with placebo.

Timeline

Start

2016-03

Primary completion

2018-11

Completion

2019-05

Publications

• Duarte G, Muresan P, Ward S, Laimon L, Pelton SI, Canniff J, Golner A, Bone F, Newton L, Fenton T, Coutinho CM, Joao EC, Santos BR, Pilotto JH, Oliveira RH, Pinto JA, Machado ES, Kreitchman R, Chakhtoura N, Mussi-Pinhata MM, Weinberg A. Immunogenicity of Conjugated and Polysaccharide Pneumococcal Vaccines Administered During Pregnancy or Postpartum to Women With HIV. J Infect Dis. 2022 Mar 15;225(6):1021-1031. doi: 10.1093/infdis/jiab567.
• Weinberg A, Muresan P, Laimon L, Pelton SI, Goldblatt D, Canniff J, Zimmer B, Bone F, Newton L, Fenton T, Kiely J, Johnson MJ, Joao EC, Santos BR, Machado ES, Pinto JA, Chakhtoura N, Duarte G, Mussi-Pinhata MM; NICHD P1091 study team. Safety, immunogenicity, and transplacental antibody transport of conjugated and polysaccharide pneumococcal vaccines administered to pregnant women with HIV: a multicentre randomised controlled trial. Lancet HIV. 2021 Jul;8(7):e408-e419. doi: 10.1016/S2352-3018(20)30339-8. Epub 2021 Apr 27.

Drugs

Indications