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Safety and Immunogenicity Study of 2 Investigational Preventive HIV Vaccines

NCT01264445 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2013-02-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an adjuvanted GSK investigational HIV vaccine and Ad35-GRIN in 4 different regimens at months 1, 2, 3, and 4.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

Adjuvanted GSK investigational HIV vaccine formulation 1

Receive at Months 0 and 1

BIOLOGICAL

Adjuvanted GSK investigational HIV vaccine formulation 2

Receive at Months 0 and 1

BIOLOGICAL

Ad35 investigational HIV vaccine

Receive at Month 0

BIOLOGICAL

Adjuvanted GSK investigational HIV vaccine formulation 2

Receive at Months 3 and 4

BIOLOGICAL

Adjuvanted GSK investigational HIV vaccine formulation 2

Receive at Months 0, 1, and 4

BIOLOGICAL

Ad35 investigational HIV vaccine

Receive at Month 4

BIOLOGICAL

Ad35 investigational HIV vaccine

Receive at Months 0, 1, and 4

BIOLOGICAL

Placebo (saline)

(Vaccine:Placebo=28:7) Groups A, B, C, and D will all have a placebo comparator component (7 volunteers will receive placebo in each group at the specified months.)

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • International AIDS Vaccine Initiative

    lead NETWORK

Principal Investigators

  • Gloria S Omosa-Manyonyi, MBChB,DPH,DLSHTM, MSc. · Kenya AIDS Vaccine Initiative

  • Juliet Mpendo, MBChB, MPH · Uganda Virus Research Institute-IAVI

  • Eugene Ruzagira, MBChB MPH · Medical Research Council-UVRI Uganda Research Unit on AIDS

  • Elwyn Chomba, BSc, MBChB, DCH, MRCP · Zambia-Emory HIV Research Project

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Kenya
  • Uganda
  • Zambia

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 NCT01264445 on ClinicalTrials.gov