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Evaluating the Safety and Immune Response to Different Combinations of the DNA-HIV-PT123 and AIDSVAX® B/E Vaccines in Healthy, HIV-Uninfected Adults

NCT02207920 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2021-10-15

No results posted yet for this study

Summary

This study will evaluate the safety, tolerability, and immune response to different combinations of two experimental HIV vaccines-the DNA-HIV-PT123 vaccine and the AIDSVAX® B/E vaccine-in healthy adults who are not infected with HIV.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

AIDSVAX B/E Vaccine

600 mcg/mL to be administered as 1 mL intramuscular (IM) injection

BIOLOGICAL

DNA-HIV-PT123 Vaccine

4 mg/mL to be administered as 1 mL IM injection

BIOLOGICAL

Placebo for DNA-HIV-PT123

Sodium chloride for injection USP, 0.9%; administered as 1 mL IM injection

BIOLOGICAL

Placebo for AIDSVAX B/E

Sodium chloride for injection USP, 0.9%; administered as 1 mL IM injection

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Michael Keefer · University of Rochester

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
2014-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

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 NCT02207920 on ClinicalTrials.gov