Evidence map›Paper›PMID 39706666›Full record

Trial reportThe Lancet. Global health2025

Safety and immunogenicity of an acellular pertussis vaccine containing genetically detoxified pertussis toxin administered to pregnant women living with and without HIV and their newborns (WoMANPOWER): a randomised controlled trial in Uganda.

Eve Nakabembe, Melanie Greenland, Kyle Amaral, Bahaa Abu-Raya, Alexander Amone, Nick Andrews, Liberty Cantrell, Elodie Lesne, Andrew Gorringe, Rachel Halkerston and 13 more

Registry-linked trialAbstract readClinical Trial, Phase IIEquivalence TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Global health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04589312 (The Safety and imMunogeNicity of Combined Pertussis-cOntaining Vaccine), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04589312 phase2completednot on this map

The Safety and imMunogeNicity of Combined Pertussis-cOntaining Vaccine (Tdap) for HIV-infected Pregnant WomEn and Their newboRns - A Randomized Clinical Trial

TypeinterventionalSponsorSt George's, University of LondonRan2020 to 2023Enrolled181ConditionsPertussisArmsStandard of care vaccines, Boostagen, (BioNet-Asia)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Eve NakabembeDepartment of Obstetrics and Gynaecology, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda; Centre for Neonatal and Paediatric Infection and Vaccine Institute, City St George's, University of London, London, UK. Electronic address: drevena@yahoo.co.uk.
Melanie GreenlandOxford Vaccine Group, NIHR Oxford Biomedical Research Centre, Department of Paediatrics, University of Oxford, Oxford, UK.
Kyle AmaralDepartment of Paediatrics, University of British Columbia, Vancouver, BC, Canada; Vaccine Evaluation Center, BC Children's Hospital Research Institute, Vancouver, BC, Canada.
Bahaa Abu-RayaDepartments of Paediatrics, Dalhousie University, Halifax, NS, Canada.
Alexander AmoneMakerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.
Nick AndrewsUK Health Security Agency, Immunisation and Vaccine Preventable Diseases Department, London, UK.
Liberty CantrellOxford Vaccine Group, NIHR Oxford Biomedical Research Centre, Department of Paediatrics, University of Oxford, Oxford, UK.
Elodie LesneUK Health Security Agency, Salisbury, UK.
Andrew GorringeUK Health Security Agency, Salisbury, UK.
Rachel HalkerstonUK Health Security Agency, Salisbury, UK.
Nikki McstrawUK Health Security Agency, Salisbury, UK.
Louisa DixonUK Health Security Agency, Salisbury, UK.
Olivia F HunterVaccine Evaluation Center, BC Children's Hospital Research Institute, Vancouver, BC, Canada.
Paul T HeathCentre for Neonatal and Paediatric Infection and Vaccine Institute, City St George's, University of London, London, UK.
Esther ImedeMedical Research Council/Uganda Virus Research Institute and London School of Hygiene & Tropical Medicine Uganda Research Unit, Entebbe, Uganda.
Mary KyohereCentre for Neonatal and Paediatric Infection and Vaccine Institute, City St George's, University of London, London, UK; Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.
Philippa MusokeMakerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.
Annettee NakimuliDepartment of Obstetrics and Gynaecology, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.
Musa SekikuboDepartment of Obstetrics and Gynaecology, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.
Stephen TaylorUK Health Security Agency, Salisbury, UK.
Valerie TusubiraMakerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.
Manish SadaranganiDepartment of Paediatrics, University of British Columbia, Vancouver, BC, Canada; Vaccine Evaluation Center, BC Children's Hospital Research Institute, Vancouver, BC, Canada.
Kirsty Le DoareCentre for Neonatal and Paediatric Infection and Vaccine Institute, City St George's, University of London, London, UK; Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda; UK Health Security Agency, Salisbury, UK.

Funding

Medical Research Council MR/T004983/1Wellcome Trust
6 · The paper itself

Abstract

backgroundImmunisation in pregnancy against pertussis can reduce severe disease in infancy. There are few data on the safety and immunogenicity of vaccines given to pregnant women living with HIV and their infants. We aimed to describe the safety and immunogenicity of a tetanus-diphtheria-acellular pertussis (TdaP) vaccine containing genetically detoxified pertussis toxin given to pregnant women living with HIV and the effect of the vaccine on infant whole-cell pertussis vaccine responses.

methodsWe conducted an observer-blind, randomised, phase 2, multicentre, non-inferiority trial evaluating safety and immunogenicity of a vaccine containing genetically detoxified acellular pertussis in pregnant women living with HIV in Uganda. Women aged at least 18 years between 16 weeks and 26 weeks of gestation were randomly assigned to receive the tetanus-diphtheria (Td) vaccine or TdaP vaccine. Stratified block randomisation using blocks of four with a 1:1:1:1 ratio stratified by participant HIV status was used to distribute participants into equal groups (50 participants per group for a total of 200 participants). The intervention was a 0·5 mL single intramuscular dose of TdaP vaccine. Td or TdaP vaccination was randomly assigned to different clinic days using randomisation software. Primary immunogenicity endpoints were anti-pertussis toxin and anti-filamentous haemagglutinin IgG concentrations in infants at delivery and 18 weeks following three doses of a whole-cell pertussis containing vaccine. This study is registered at ClinicalTrials.gov, NCT04589312.

findingsBetween Oct 28, 2020, and May 21, 2021, 438 pregnant women were screened and 181 were randomly assigned: 90 to TdaP vaccine (40 HIV-positive participants and 50 HIV-negative participants) and 91 to Td vaccine (41 HIV-positive participants and 50 HIV-negative participants). All participants received Td, and 4 weeks later, 177 received either Td or TdaP. 32 serious adverse events occurred, none related to the study vaccine. At delivery, anti-pertussis toxin IgG concentrations for TdaP versus Td were superior in infants who were HIV-exposed but uninfected (geometric mean ratio 9·61, 95% CI 5·21-17·74) and HIV-unexposed infants (21·6, 11·2-41·7). In infants at 18 weeks, anti-pertussis toxin IgG concentrations for TdaP versus Td-vaccinated mothers were significantly lower for both infants who were HIV-exposed but uninfected (0·19, 0·09-0·43) and infants who were not HIV-exposed (0·17, 0·08-0·33). Serum bactericidal antibody generation following whole-cell pertussis vaccination in infants was not affected.

interpretationTdaP was safe and immunogenic in pregnant women living with HIV and their infants. TdaP provided superior anti-pertussis toxin IgG concentrations at delivery. Following routine vaccination with whole-cell pertussis vaccine, infants born to women receiving the TdaP vaccine had lower anti-pertussis toxin IgG concentrations than infants born to women receiving Td. In the absence of a correlate of protection against pertussis disease, the clinical significance of this finding is unclear.

fundingMedical Research Council Joint Clinical Trials, Canadian Institutes of Health Research, and British Columbia Children's Hospital Research Institute.

Indexed as

Diphtheria-Tetanus-acellular Pertussis VaccinesHIV InfectionsPertussis ToxinWhooping CoughAdultFemaleHumansImmunogenicity, VaccineInfant, NewbornPregnancyPregnancy Complications, InfectiousUgandaYoung AdultDiphtheria-Tetanus-acellular Pertussis VaccinesPertussis Toxin

Identifiers

PMID39706666
PMCPMC11659843

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.