MedTrace Logo

Evaluating the Safety and Immune Response to Five Different Combinations of HIV Vaccines in Healthy, HIV-Uninfected Adults

NCT01964937 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-10-15

No results posted yet for this study

Summary

This study will evaluate the safety and immune response to five different combinations of three HIV vaccines in healthy, HIV-uninfected adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

DNA-HIV-PT123

The DNA-HIV-PT123 (containing clade C ZM96 gag and gp140 along with CN54 pol-nef) will be administered at a dose of 4 mg IM.

BIOLOGICAL

NYVAC-HIV-PT1

The NYVAC-HIV-PT1 vaccine (containing clade C ZM96 gp140) will be administered at a dose of greater than or equal to 5×10\^6 plaque-forming units (PFU)IM, for a planned maximum dose of 1.2×10\^8 PFU.

BIOLOGICAL

NYVAC-HIV-PT4

The NYVAC-HIV-PT4 vaccine (containing ZM96 gag-CN54 pol-nef) will be administered at a dose of greater than or equal to 5×10\^6 PFU IM, for a planned maximum dose of 1.1×10\^7 PFU.

BIOLOGICAL

AIDSVAX B/E®

The AIDSVAX B/E ® vaccine will be administered as a 1 mL/600 mcg dose IM.

BIOLOGICAL

Placebo vaccine

The placebo vaccine contains sodium chloride for injection USP, 0.9% and will be administered as a 1 mL injection IM.

Sponsors & Collaborators

  • IPPOX Foundation

    collaborator OTHER

  • EuroVacc Foundation

    collaborator OTHER

  • Global Solutions for Infectious Diseases

    collaborator UNKNOWN

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Michael Keefer · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Primary Completion
2014-04-30
Completion
2014-04-30

More Related Trials

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 NCT01964937 on ClinicalTrials.gov