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Evaluating the Safety and Immune Response to Two HIV Vaccine Regimens in Healthy, HIV-Uninfected Adults in the United States and South Africa

NCT01927835 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL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 immune response to two different HIV vaccine regimens in healthy, HIV-uninfected people in the United States and South Africa.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

DNA-HIV-PT123 vaccine

4 mg of DNA encoding clade C ZM96 Gag and gp140, CN54 Pol-Nef, administered IM

BIOLOGICAL

NYVAC-HIV-PT1 vaccine

≥ 5x10\^6 PFU/ml encoding clade C ZM96 gp140 for a planned maximum dose of 1.2x10\^8 PFU/ml; administered IM

BIOLOGICAL

NYVAC-HIV-PT4 vaccine

≥ 5x10\^6 PFU encoding ZM96 Gag and CN54 Pol-Nef, administered IM for a planned maximum dose of 1.1x10\^7 PFU/ml; administered IM

BIOLOGICAL

AIDSVAX B/E vaccine

300 mcg of subtype B (MN) HIV gp120 glycoprotein and 300 mcg of subtype E (A244) HIV gp120 glycoprotein absorbed onto 600 mcg of aluminum hydroxide gel adjuvant, administered IM

BIOLOGICAL

Placebo for DNA/NYVAC/AIDSVAX

Sodium Chloride for injection, 0.9%; administered IM

Sponsors & Collaborators

  • HIV Vaccine Trials Network

    collaborator NETWORK

  • IPPOX Foundation

    collaborator OTHER

  • EuroVacc Foundation

    collaborator OTHER

  • Global Solutions for Infectious Diseases (GSID)

    collaborator UNKNOWN

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Magdalena Sobieszczyk · Columbia University

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

Primary Completion
2017-01-31

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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 NCT01927835 on ClinicalTrials.gov