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Pertussis Vaccination Among HIV-infected and HIV-uninfected Pregnant Women

NCT05264662 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2026-05-15

No results posted yet for this study

Summary

Pertussis (also known as whooping cough) is a highly contagious, vaccine-preventable respiratory tract disease, caused by the bacteria Bordetella pertussis. It can affect people of all ages, however young unimmunised or partially immunised infants are the most vulnerable group with the highest rates of complications and death. Recent surveillance data and an increase in the number of pertussis outbreaks being reported nationally, indicate an increase in the incidence of pertussis disease in South Africa.To date there is no data on the effect of vaccinating HIV-infected pregnant women with pertussis-containing vaccines, although there is no reason to think that vaccinating these women would be harmful for them or their foetus. The knowledge gaps on the immunogenicity, safety and VE of pertussis vaccination of HIV-infected pregnant women should be addressed. Adacel which is a registered and licensed vaccine manufactured by Sanofi Pasteur, will be tested in this study.

Conditions

  • dTap Vaccine

Interventions

DRUG

Adacel (Tdap)

Administer Adacel to hiv infected and hiv uninfected pregnant mothers

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Farzanah Laher

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2025-03-12
Completion
2025-03-12

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05264662 on ClinicalTrials.gov