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Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP

NCT00076037 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2021-10-14

No results posted yet for this study

Summary

The effectiveness of a vaccine can be improved by using a "prime boost strategy" or by using an adjuvant. A prime boost strategy is the administration of one type of vaccine (the primer) followed by the administration of another type vaccine (the booster). An adjuvant is a substance that can enhance the immune response when given at the same time as a vaccine.

This study will evaluate the safety of and immune response to a vaccine designed to be used as part of a prime boost strategy. The study will also evaluate the vaccine when given with an adjuvant. The vaccine in this study is not produced from live HIV or from infected cells. It does not contain HIV, and it cannot cause HIV infection.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

HIV CTL MEP administered with RC529-SE adjuvant

DRUG

GM-CSF

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Paul Spearman, MD · Vanderbilt University

  • Spyros Kalams, MD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2004-04-30
Completion
2006-06-30

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT00076037 on ClinicalTrials.gov