NCT05264662

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 511 (actual)
• Sponsor: Farzanah Laher · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Adacel (Tdap)	Administer Adacel to hiv infected and hiv uninfected pregnant mothers

Timeline

• Start date: 2022-03-08
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2022-03-03
• Last updated: 2024-05-28

Locations

1 site across 1 country: South Africa