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Evaluating the Safety and Immune Response to an HIV Vaccine in Healthy, HIV-Uninfected Adults Who Have Participated in Previous HIV Vaccine Clinical Trials and in Adults Who Have Not Participated in Previous HIV Vaccine Clinical Trials

NCT01376726 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

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 an HIV vaccine in healthy, HIV-uninfected adults who have participated in a previous HIV vaccine clinical trial and in healthy, HIV-uninfected adults who have not participated in a previous HIV vaccine clinical trial.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

Sub C gp140 Vaccine

Sub C gp140 100 mcg will be combined with MF59C.1 and administered as one injection (0.5 mL) IM in either deltoid at baseline and Month 6. Participants in the study extension will receive an additional injection of the study vaccine approximately 14 to 20 months after their second (Month 6) vaccination.

BIOLOGICAL

MF59C.1 Adjuvant

Sub C gp140 100 mcg will be combined with MF59C.1 and administered as one injection (0.5 mL) IM in either deltoid at baseline and Month 6. Participants in the study extension will receive an additional injection of the study vaccine approximately 14 to 20 months after their second (Month 6) vaccination.

Sponsors & Collaborators

  • Novartis Vaccines and Diagnostics, Inc

    collaborator UNKNOWN

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Paul Spearman · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

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 NCT01376726 on ClinicalTrials.gov