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Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX® B/E

NCT01931358 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2021-03-26

No results posted yet for this study

Summary

The primary purpose of the study is to better define the relative contributions of AIDSVAX® B/E alone, ALVAC-HIV alone, or ALVAC-HIV plus AIDSVAX® B/E combination to the observed immune profile in the weeks and months after receiving the original prime and boost vaccine regimen from study protocol RV 144, and their booster effects in both the systemic and mucosal compartments. In addition, this study will provide more intensive and comprehensive characterization of the innate, cell-mediated and humoral immune responses than possible within the RV 144 study.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

ALVAC-HIV

1 mL intramuscular injection containing 10\^6 CCID50/dose

BIOLOGICAL

AIDSVAX B/E

1 mL per injection (300 ug dose/antigen for a total of 600ug/dose administered)

BIOLOGICAL

ALVAC-HIV Placebo

1 mL per injection

BIOLOGICAL

AIDSVAX B/E Placebo

1 mL per injection

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Punnee Pitisuttithum, MD, DTM&H · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-24
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Thailand

Study Locations

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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 NCT01931358 on ClinicalTrials.gov