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P1072

Safety and Immunogenicity of a Live, Attenuated, Rotavirus Vaccine (RotaTeq™) in HIV-1 Infected and Uninfected Children Born to HIV-1 Infected Mothers

Study Status

Concluded

DAIDS Number

10638

IND Number

13,979

Clinical Trials Link

Summary

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:

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20 November 2020

Study Chair

Study Vice-Chair

NICHD Medical Officer

DAIDS Clinical Representative

DAIDS Protocol Pharmacist

Data Manager

ICAB Representative

Immunologist

Laboratory Data Manager (LDM)

Laboratory Technologist

Senior Statistician

Virologist

Abstracts

Intestinal damage and inflammation in perinatally HIV-1-infected African infants

Conference

CROI 2018

Study

P1072

Authors

W Koay, J Lindsey, P Uprety, A Weinberg, M Levin, M Bwakura-Dangarembizi, D Persaud

B and T cell subsets and immunogenicity of rotavirus vaccine in PHIV and PHEU Infants

Conference

CROI 2017

Study

P1072

Authors

A Weinberg, JC Lindsey, R Bosch, D Persaud, P Sato, B Heckman, K Richardson, A Zadzilka, M Nelson, MJ Levin

Safety and Immunogenicity of Pentavalent Rotavirus Vaccine in HIV-Infected and HIV-Exposed Infants in Africa (IMPAACT P1072)

Conference

IDWeek 2015

Study

P1072

Authors

Levin MJ, Lindsey JC, Kaplan SS, Schimana W, Lawrence J, Bwakura-Dangarembiziutsa M, Ogwu A, Chi B, Sato P, Siberry G, Nelson M, Hille D, Weinberg G, Weinberg A

Differences in gut microbial diversity in HIV infected vs exposed, uninfected infants

Conference

CROI 2019

Study

P1072

Authors

WLA Koay, H Koh, M Bwakura-Dangarembizi, MJ Levin, A Weinberg, N Zhao, D Persaud

Enhanced Inflammation and Rotavirus Vaccine Responses in Perinatal HIV-1 Infection.

Conference

CROI 2016

Study

P1072

Authors

Priyanka Uprety, Jane Lindsey, Myron Levin, Kaitlin Rainwater-Lovett, Carrie Ziemniak, MERCK#1, MERCK#2, P1072#4, Adriana Weinberg, Deborah Persaud

Manuscripts