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Evaluating the Safety and Immunogenicity of the IHV01 Protein Vaccine Primed and Co-Administered With HIV DNA CON-S Env Vaccine in Healthy, HIV-1-Uninfected Adults

NCT03505060 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-10-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immunogenicity of the IHV01 protein vaccine primed and co-administered with HIV DNA CON-S env vaccine in healthy, HIV-1-uninfected adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

DNA CON-S env

Administered by intramuscular injection in the deltoid.

BIOLOGICAL

IHV01

Administered by intramuscular injection in the deltoid.

BIOLOGICAL

Placebo

Sodium Chloride for Injection, USP 0.9%; administered by intramuscular injection in the deltoid.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Susan Buchbinder · San Francisco Department of Public Health

  • Sonya Heath · University of Alabama at Birmingham

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
2019-01-01
Primary Completion
2019-05-31
Completion
2019-11-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03505060 on ClinicalTrials.gov