Effect of Maternal Immunization With 10-Valent Pneumococcus Conjugate Vaccine (PCV-10), 23-Valent Pneumococcus Polysaccharide Vaccine, or Placebo on the Immunogenicity of PCV-10 in Human Immunodeficiency Virus–Exposed Uninfected Infants: A Randomized Clinical Trial

Abstract Background The effect of pneumococcal vaccination of mothers with human immunodeficiency virus (HIV) on infant responses to childhood vaccination has not been studied. We compared the immunogenicity of 10-valent pneumococcus conjugate vaccine (PCV-10) in HIV-exposed uninfected infants born...

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Published in:	Clinical infectious diseases Vol. 75; no. 6; pp. 996 - 1005
Main Authors:	Mussi-Pinhata, Marisa M, Ward, Shawn, Laimon, Lauren, Pelton, Stephen I, Canniff, Jennifer, Golner, Amanda, Bone, Frederic, Newton, Lassallete, Muresan, Petronella, Fenton, Terence, Johnson, Michael J, João, Esau C, Santos, Breno R, Pilotto, Jose H, Oliveira, Ricardo H, Pinto, Jorge A, Dal Bó, Andrea G B L, Kreitchmann, Regis, Chakhtoura, Nahida, Duarte, Geraldo, Weinberg, Adriana
Format:	Journal Article
Language:	English
Published:	US Oxford University Press 29-09-2022
Subjects:	Antibodies, Bacterial - therapeutic use Female HIV HIV Infections - drug therapy Humans Infant Infant, Newborn Major Pneumococcal Infections - prevention & control Pneumococcal Vaccines Polysaccharides Pregnancy Streptococcus pneumoniae Vaccination Vaccines, Conjugate vaccine immunogenicity infant HIV infection maternal immunization pneumococcal vaccine
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Summary:	Abstract Background The effect of pneumococcal vaccination of mothers with human immunodeficiency virus (HIV) on infant responses to childhood vaccination has not been studied. We compared the immunogenicity of 10-valent pneumococcus conjugate vaccine (PCV-10) in HIV-exposed uninfected infants born to mothers who received PCV-10, 23-valent pneumococcus polysaccharide vaccine (PPV-23), or placebo during pregnancy. Methods Antibody levels against 7 serotypes were measured at birth, before the first and second doses of PCV-10m and after completion of the 2-dose regimen in 347 infants, including 112 born to mothers who received PPV-23, 112 who received PCV-10, and 119 who received placebo during pregnancy. Seroprotection was defined by antibody levels ≥0.35 µg/mL. Results At birth and at 8 weeks of life, antibody levels were similar in infants born to PCV-10 or PPV-23 recipients and higher than in those born to placebo recipient. After the last dose of PCV-10, infants in the maternal PCV-10 group had significantly lower antibody levels against 5 serotypes than those in the maternal PPV-23 group and against 3 serotypes than those in the maternal placebo group, and they did not have higher antibody levels against any serotype. The seroprotection rate against 7 serotypes was 50% in infants in the maternal PCV-10 group, compared with 71% in both of the maternal PPV-23 and placebo groups (P < .001). Conclusions Administration of PCV-10 during pregnancy was associated with decreased antibody responses to PCV-10 and seroprotection rates in infants. Considering that PCV-10 and PPV-23 had similar immunogenicity in pregnant women with HIV and that administration of PPV-23 did not affect the immunogenicity of PCV-10 in infants, PPV-23 in pregnancy may be preferred over PCV-10. Infants born to PCV-10 immunized mothers had lower antibody responses and seroprotection after the primary immunization with PCV-10 compared to infants born to PPV-23 or placebo recipients. Administration of PPV-23 may be preferred over PCV-10 in pregnant women with HIV.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 Potential conflicts of interest. M. M. M. P. and G. D. report provision of PCV-10 by donation from Centro de Vigilância Epidemiológica da Secretaria da Saúde do Estado de São Paulo, São Paulo, Brazil. L. L. reports that Westat was the contract research organization contracted through the National Institutes of Health (NIH) for a task order for the current study. S. I. P. reports receipt of personal fees from Merck, Sanofi, and Pfizer; investigator-initiated grants from the NIH and Pfizer and Merck Vaccines to study surveillance of invasive pneumococcal disease, host defenses against Streptococcus pneumoniae, and the impact of severe acute respiratory syndrome coronavirus 2 on nasopharyngeal microbiome; and consulting fees from Pfizer and Merck Vaccine for participation in advisory board meetings, consulting on research projects at PAI Life Sciences and EVIDERA, and participation on a data safety and monitoring board for next-generation PCVs for Sanofi Pasteur. N. C. is employed by the NIH. A. W. has received grants from the NIH, GlaxoSmithKline, Janssen and Merck; consulting fees from Merck; and payment or honoraria from Merck. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
ISSN:	1058-4838 1537-6591
DOI:	10.1093/cid/ciac026