P1072 (DAIDS ID 10638): Safety and Immunogenicity of a Live, Attenuated, Rotavirus Vaccine (RotaTeqTM) in HIV-Infected and Uninfected Children Born to HIV-Infected Mothers

Study Status Study Restriction

Closed to Follow Up

Non-US

What is P1072?

P1072 is a phase II, randomized, double-blind, placebo controlled study of the safety and immunogenicity of a live, attenuated rotavirus vaccine (RotaTeq™) in HIV-1 infected and uninfected children  ≥2 weeks to <15 weeks of age born to HIV-1 infected mothers.  This study will enroll 320 children (160 HIV-1 infected and 160 HIV-uninfected).  Participants will receive three doses (2.0 mL each) of either a live attenuated rotavirus vaccine (RotaTeq™) or placebo.  The primary objectives of this study are to evaluate the safety of any dose of RotaTeq™ and to evaluate the immunogenicity of a 3-dose regimen of RotaTeq™ in HIV-1 infected and uninfected children born to HIV-1 infected mothers.

Study Documents:

Sites where the study is implemented:

CRS ID Site Name City Country

12701

Gaborone Prevention/Treatment Trials CRS

Gaborone

Botswana

12702

Molepolole Prevention/Treatment Trials CRS

Molepolole

Botswana

5118

Kilimanjaro Christian Medical CRS

Moshi

Tanzania

30273

George Clinic CRS

Lusaka

Zambia

31890

Harare Family Care CRS

Harare

Zimbabwe

Study contacts:

Clinical Trials Specialist: JL Ariansen

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.