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Evaluating the Safety and Priming Response of an HIV Vaccine Regimen in Healthy, HIV-Uninfected Adults

NCT01799954 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2015-03-25

No results posted yet for this study

Summary

This study will evaluate the safety of and the body's immune response to experimental HIV vaccine regimens using different vaccine priming combination, and boosting with the vaccines NYVAC and AIDSVAX® B/E.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

DNA-HIV-PT123

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

BIOLOGICAL

NYVAC-HIV-PT1

(along with NYVAC-HIV-PT4); ≥ 5x106 PFU encoding clade C ZM96 gp140 and ZM96 Gag and CN54 Pol-Nef, administered IM

BIOLOGICAL

NYVAC-HIV-PT4

(along with NYVAC-HIV-PT1); ≥ 5x106 PFU encoding clade C ZM96 gp140 and ZM96 Gag and CN54 Pol-Nef, administered IM

BIOLOGICAL

AIDSVAX® B/E

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

BIOLOGICAL

Placebo for DNA/NYVAC

Sodium Chloride for injection, 0.9% administered IM

BIOLOGICAL

Placebo for AIDSVAX(R) B/E

600 mcg of aluminum hydroxide adjuvant, administered IM

Sponsors & Collaborators

  • HIV Vaccine Trials Network

    lead NETWORK

Principal Investigators

  • Giuseppe Pantaleo, MD · Centre Hospitalier Universitaire Vaudois Hospices (CHUV)

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
2012-08-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Switzerland

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 NCT01799954 on ClinicalTrials.gov