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Safety of and Immune Response to a DNA HIV Vaccine Boosted With a Modified Vaccinia HIV Vaccine and Protein HIV Vaccine in Healthy Adults

NCT01418235 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2019-06-21

No results posted yet for this study

Summary

Sub-Saharan Africa is the region most affected by the global Human Immunodeficiency Virus (HIV) epidemic. A vaccine is the most promising preventive approach against new HIV infections. The purpose of this study is to evaluate the safety and immunogenicity of 4 experimental preventive HIV vaccine regimens in HIV-uninfected adults in South Africa.

Conditions

  • HIV Seronegativity
  • HIV Preventive Vaccine

Interventions

BIOLOGICAL

MVA-C + gp140/MF59

SAAVI MVA-C administered as 0.5 ml intramuscularly in right deltoid, with placebo in left deltoid, at Month 0; SAAVI MVA-C administered as 0.5 ml intramuscularly in right deltoid at Month 1; Novartis subtype C gp140 admixed with Novartis MF59 adjuvant administered as 0.5 ml intramuscularly in left deltoid, with placebo in right deltoid, at Months 3, 6. Placebo comparator: Placebo administered at Months 0, 1, 3, 6

BIOLOGICAL

MVA-C + gp140/MF59

SAAVI MVA-C administered as 0.5 ml intramuscularly in right deltoid, with Novartis subtype C gp140 admixed with Novartis MF59 adjuvant administered as 0.5 ml intramuscularly in left deltoid, at Months 0, 3; placebo in right deltoid at Month 1; placebo in each deltoid at Month 6 Placebo comparator: Placebo administered at Months 0, 1, 3, 6

BIOLOGICAL

DNA-C2 + MVA-C

SAAVI DNA-C2 administered as 1 ml intramuscularly in right deltoid, with placebo in left deltoid, at Month 0; SAAVI DNA-C2 administered as 1 ml intramuscularly in right deltoid at Month 1; SAAVI MVA-C administered as 0.5 ml intramuscularly in right deltoid, with placebo in left deltoid, at Months 3, 6 Placebo comparator: Placebo administered at Months 0, 1, 3, 6

BIOLOGICAL

DNA-C2 + MVA-C + gp140/MF59

SAAVI DNA-C2 administered as 1 ml intramuscularly in right deltoid, with placebo in left deltoid, at Month 0; SAAVI DNA-C2 administered as 1 ml intramuscularly in right deltoid at Month 1; SAAVI MVA-C administered as 0.5 ml intramuscularly in right deltoid at Months 3, 6; Novartis subtype C gp140 admixed with Novartis MF59 adjuvant administered as 0.5 ml intramuscularly in left deltoid, with placebo in right deltoid, at Months 3, 6 Placebo comparator: Placebo administered at Months 0, 1, 3, 6

Sponsors & Collaborators

  • South Africa AIDS Vaccine Initiative

    collaborator NETWORK

  • HIV Vaccine Trials Network

    lead NETWORK

Principal Investigators

  • Gavin Churchyard · Aurum Institute for Health Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-12-19
Primary Completion
2013-10-07
Completion
2015-12-09

Countries

  • South Africa

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 NCT01418235 on ClinicalTrials.gov