NCT05264662CompletedPhase 4
Pertussis Vaccination Among HIV-infected and HIV-uninfected Pregnant Women
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 511 (actual)
- First submitted
- 24 Jan 2022
- Start date
- 8 Mar 2022
- Primary completion date
- 12 Mar 2025
- Lead sponsor
- Farzanah Laher
- NCT number
- NCT05264662
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 511
- From 8 Mar 2022 to the primary completion date, 12 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of any live licensed vaccine ≤14 days prior to study initiation.
- 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.
- History of a severe adverse reaction to previous vaccines (vaccinated group only).
- 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.
Other illness
- 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.
- Uncontrolled major psychiatric disorder.
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 39 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chris Hani Baragwanath Academic Hospital Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.