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Safety and Immunogenicity Study of Ad26-ENVA and Ad35-ENV HIV Vaccines in Healthy HIV-uninfected Adults

NCT01215149 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2012-12-17

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of Ad26.ENVA.01 and Ad35-ENV in low-risk for HIV-uninfected healthy adults administered in heterologous and homologous prime-boost regimens at different time intervals.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

Ad35-ENV vaccine

Recombinant adenovirus serotype 35 vector vaccine 5x10\^10 vp, delivered IM

BIOLOGICAL

Ad26.ENVA.01 vaccine

Recombinant adenovirus serotype 26 vector vaccine, 5x10\^10 vp delivered IM

BIOLOGICAL

Placebo Control

Colorless 10mm Tris/HCl buffer

Sponsors & Collaborators

  • HIV Vaccine Trials Network

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • Ragon Institute of MGH, MIT and Harvard

    collaborator OTHER

  • International AIDS Vaccine Initiative

    lead NETWORK

Principal Investigators

  • Lindsey Baden, MD · Brigham and Women's Hospital, Boston, MA, USA

  • Gaudensia Mutua, MB ChB, MPH · Kenya AIDS Vaccine Initiative, Kangemi, Kenya

  • Etienne Karita, MD, M.Sc., MSPH · Projet San Francisco

  • Linda-Gail Bekker, MD · Desmond Tutu HIV Foundation-Emavundleni Research Center

  • Glenda Gray, MBBCH, FCPaeds(SA) · Perinatal HIV Research Unit

  • Liesl Page-Shipp · Aurum Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States
  • Kenya
  • Rwanda
  • South Africa

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01215149 on ClinicalTrials.gov