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Article

Safety, Tolerability, and Immunogenicity of RSVpreF Vaccine in Pregnant Individuals Living with HIV

by
Landon Myer
1,
Emily Wasserman
2,
Saiqa Tabasum
3,
Emma Shittu
3,
Yanping Liu
4,
Lisa Jose
5,
Elizea Horne
6,
Robert S. Moraba
7,
Agatha Wilhase
8,
Heather J. Zar
9,
Nazreen Hussen
10,
Mokgadi S. Mogashoa
11,
Mookho Malahleha
12,
Shabir A. Madhi
13,14,
Uzma N. Sarwar
2,
Hasra Snaggs
2,
Rahsan Erdem
2,*,
David Radley
2,
Elena V. Kalinina
2,
Barbara A. Pahud
2,
Maria Maddalena Lino
15,
Olympia Evdoxia Anastasiou
16,
Kena A. Swanson
2,
Annaliesa S. Anderson
2,
Alejandra Gurtman
2 and
Iona Munjal
2add Show full author list remove Hide full author list
1
Division of Epidemiology and Biostatistics, School of Public Health, University of Cape Town, Cape Town 7925, South Africa
2
Pfizer Vaccines, Pfizer Inc., Pearl River, NY 10965, USA
3
Pfizer Vaccines, Pfizer Ltd., Buckinghamshire, SL7 1YL, UK
4
Pfizer Vaccines, Pfizer Inc., Collegeville, PA 19426, USA
5
South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, University of the Witwatersrand, Johannesburg 1864, South Africa
6
Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2001, South Africa
7
Setshaba Research Centre, Tshwane City 0152, South Africa
8
REIMED (Pty) Ltd., Johannesburg 1459, South Africa
9
Department of Paediatrics and Child Health, Red Cross War Memorial Children’s Hospital, SA-MRC Unit on Child & Adolescent Health, University of Cape Town, Cape Town 8001, South Africa
10
Worthwhile Clinical Trials, Benoni 1500, South Africa
11
Botho Ke Bontle Healthcare, Pretoria 0184, South Africa
12
Synergy Biomed Research Institute, East London 5201, South Africa
13
South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2195, South Africa
14
Wits Infectious Diseases and Oncology Research Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2195, South Africa
15
Worldwide Safety, Pfizer Srl, 20152 Milan, Italy
16
Worldwide Safety, Pfizer Hellas SA, Thessaloniki 55535, Greece
 
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*
Author to whom correspondence should be addressed.
Vaccines 2025, 13(12), 1218; https://doi.org/10.3390/vaccines13121218 (registering DOI)
Submission received: 17 October 2025 / Revised: 20 November 2025 / Accepted: 28 November 2025 / Published: 1 December 2025
(This article belongs to the Special Issue Maternal and Infant Vaccines)
Versions Notes

Abstract

Background/Objectives: HIV-exposed uninfected (HEU) infants experience increased severe respiratory syncytial virus lower respiratory tract illness (RSV-LRTI) rates compared with HIV-unexposed infants. Maternal bivalent RSVpreF vaccination can prevent infant RSV-LRTI but data from HEU infants are lacking. Methods: This phase 3 randomized, double-blinded trial assessed RSVpreF safety and immunogenicity in pregnant participants from South Africa living with HIV and their infants. Maternal participants with stable HIV disease taking antiretroviral therapy received RSVpreF or placebo (24–36 weeks’ gestation). Primary safety endpoints included reactogenicity through 7 days after vaccination (maternal participants), adverse events (AEs) through 1 month after vaccination (maternal participants) or birth (infants), and serious AEs (SAEs) throughout the study (maternal participants) or through 6 months after birth (infants). Immune responses were evaluated by 50% RSV-A and RSV-B neutralizing titers prevaccination and at delivery (maternal participants) or birth (infants). Results: Overall, 343 maternal participants received RSVpreF (n = 172) or placebo (n = 171). Most reactogenicity events were mild/moderate. AEs and SAEs were generally reported at similar frequencies in maternal RSVpreF and placebo groups including percentages of hypertensive disorders of pregnancy. There were no safety concerns in infants; percentages of reported AEs and SAEs were generally similar between RSVpreF and placebo groups and no difference in preterm birth. RSVpreF elicited high maternal neutralizing RSV-A and RSV-B immune responses, with efficient RSV antibody transplacental transfer to infants demonstrated by levels greater than the placebo group at birth (geometric mean ratios (GMRs) of RSVpreF to placebo were 7.8 for RSV-A and 6.8 for RSV-B) and by comparison with a cohort of HIV-unexposed infants from the pivotal phase 3 efficacy trial (GMRs of HEU to HIV-unexposed infants were 0.86 for RSV-A and 0.72 for RSV-B). Conclusions: These results support maternal RSVpreF vaccination among those living with stable HIV for preventing RSV-LRTI in HEU infants. (NCT06325657).
Keywords: clinical trial; HIV; immunogenicity; infants; LRTI; maternal vaccination; RSV; safety; transplacental transfer clinical trial; HIV; immunogenicity; infants; LRTI; maternal vaccination; RSV; safety; transplacental transfer

Share and Cite

MDPI and ACS Style

Myer, L.; Wasserman, E.; Tabasum, S.; Shittu, E.; Liu, Y.; Jose, L.; Horne, E.; Moraba, R.S.; Wilhase, A.; Zar, H.J.; et al. Safety, Tolerability, and Immunogenicity of RSVpreF Vaccine in Pregnant Individuals Living with HIV. Vaccines 2025, 13, 1218. https://doi.org/10.3390/vaccines13121218

AMA Style

Myer L, Wasserman E, Tabasum S, Shittu E, Liu Y, Jose L, Horne E, Moraba RS, Wilhase A, Zar HJ, et al. Safety, Tolerability, and Immunogenicity of RSVpreF Vaccine in Pregnant Individuals Living with HIV. Vaccines. 2025; 13(12):1218. https://doi.org/10.3390/vaccines13121218

Chicago/Turabian Style

Myer, Landon, Emily Wasserman, Saiqa Tabasum, Emma Shittu, Yanping Liu, Lisa Jose, Elizea Horne, Robert S. Moraba, Agatha Wilhase, Heather J. Zar, and et al. 2025. "Safety, Tolerability, and Immunogenicity of RSVpreF Vaccine in Pregnant Individuals Living with HIV" Vaccines 13, no. 12: 1218. https://doi.org/10.3390/vaccines13121218

APA Style

Myer, L., Wasserman, E., Tabasum, S., Shittu, E., Liu, Y., Jose, L., Horne, E., Moraba, R. S., Wilhase, A., Zar, H. J., Hussen, N., Mogashoa, M. S., Malahleha, M., Madhi, S. A., Sarwar, U. N., Snaggs, H., Erdem, R., Radley, D., Kalinina, E. V., ... Munjal, I. (2025). Safety, Tolerability, and Immunogenicity of RSVpreF Vaccine in Pregnant Individuals Living with HIV. Vaccines, 13(12), 1218. https://doi.org/10.3390/vaccines13121218

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