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Evaluating the Safety and Immune Response to Three HIV Vaccine Schedules in Healthy, HIV-Uninfected Adults

NCT01783977 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2021-10-15

No results posted yet for this study

Summary

NOTE: This study has stopped enrolling new participants, and all study vaccinations for currently enrolled participants have been stopped.

Currently, there are no vaccines approved for the prevention of HIV infection, but there are many clinical trials taking place that are studying experimental HIV vaccines. The purpose of this study is to evaluate the safety and tolerability of three different HIV vaccine schedules in healthy, HIV-uninfected adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

DNA-HIV-PT123 vaccine

DNA-HIV-PT123 4 mg/mL; administered as 1 mL IM in participant's deltoid

BIOLOGICAL

NYVAC-HIV-PT1 vaccine

NYVAC-HIV-PT1 at greater than or equal to 5x10\^6 plaque-forming units (PFU)/ml for a planned maximum dose of 1.2x10\^8 PFU/ml; administered as 1 mL IM in participant's deltoid

BIOLOGICAL

NYVAC-HIV-PT4 vaccine

NYVAC-HIV-PT4 at greater than or equal to 5x10\^6 PFU/ml for a planned maximum dose of 1.1x10\^7 PFU/ml; administered as 1 mL IM in participant's deltoid

BIOLOGICAL

Placebo for DNA-HIV-PT123 vaccine

Placebo for DNA-HIV-PT123 administered as 1 mL IM in participant's deltoid

BIOLOGICAL

Placebo for NYVAC-HIV-PT1 vaccine

Placebo for NYVAC-HIV-PT1 vaccine administered as 1 mL IM in participant's deltoid

BIOLOGICAL

Placebo for NYVAC-HIV-PT4 vaccine

Placebo for NYVAC-HIV-PT4 vaccine administered as 1 mL IM in the participant's deltoid

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Giuseppe Pantaleo · 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
2013-04-30
Primary Completion
2014-09-30
Completion
2018-10-24

Countries

  • United States
  • Switzerland

Study Locations

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 NCT01783977 on ClinicalTrials.gov