Loading clinical trials...

Pertussis Vaccination Among HIV-infected and HIV-uninfected Pregnant Women | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE4

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

NCT05264662•Farzanah Laher

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.

Eligibility

Age

18 - 39 years

Sex

FEMALE

Healthy Volunteers

Yes

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.
+1 more criteria

Locations (1)

Chris Hani Baragwanath Academic Hospital

Johannesburg, GP, South Africa

Key Dates

Start Date

March 8, 2022

Primary Completion Date

May 1, 2025

Completion Date

June 1, 2025

Last Updated

May 28, 2024

Enrollment

511

ACTUAL participants

Conditions

dTap Vaccine

Interventions

Adacel (Tdap)

DRUG

Study of Live Attenuated Varicella Vaccine Co-administered with MMR Vaccine or DTaP Vaccine

NCT06891872

Varicella (chickenpox)MMR Vaccine+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions