New study tests whooping cough vaccine in pregnant women with HIV
NCT ID NCT05264662
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how well the whooping cough (pertussis) vaccine works in pregnant women with and without HIV, and whether it is safe for them and their babies. Over 500 pregnant women received the vaccine during their second or third trimester. Researchers measured antibody levels in the mothers and their infants to see if the vaccine provides protection against whooping cough.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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511 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Mar 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 39 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pregnant women age ≥18 years to \<39 years (vaccinated group only). * Gestational age 20-36 weeks documented by the approximate date of the last menstrual period and corroborated by physical or sonargraphic exam (vaccinated group only). * Documented to be HIV-infected or HIV-uninfected. * Good general maternal health. * Able to understand and comply with planned study procedures. * Able and willing to provide written informed consent for themselves and infant Exclusion Criteria: * Receipt of any live licensed vaccine ≤14 days prior to study initiation. * Any significant (in the opinion of the site investigator) acute illness. * Use of anti-cancer systemic chemotherapy or radiation therapy ≤48 weeks of study enrolment or has immunosuppression as a result of an underlying illness or treatment. * Long term use of glucocorticoids, including oral or parenteral prednisone ≥20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) ≤12 weeks of study entry, or high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) ≤12 weeks before study entry (nasal and topical steroids are allowed). * Receipt of corticosteroids for preterm labour ≤14 days before study entry. * Receipt of immunoglobulin or other blood products (with exception of Rho D immune globulin) ≤12 weeks prior to enrolment in this study or is scheduled to receive immunoglobulin or other blood products (with the exception of Rho D immune globulin) during pregnancy or for the first 24 weeks after delivery. * Receipt of IL2, IFN, GMCSF or other immune mediators ≤12 weeks before enrolment. * Uncontrolled major psychiatric disorder. * History of a severe adverse reaction to previous vaccines (vaccinated group only). * Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. * Pregnancy complications (in the current pregnancy) such as pre-term labour, hypertension (BP \>140/90 in the presence of proteinuria or BP \>150/100, with or without proteinuria or currently on antihypertensive medication) and pre-eclampsia.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chris Hani Baragwanath Academic Hospital
Johannesburg, GP, 2192, South Africa