Evaluating the Safety and Immune Response to Three Different DNA HIV Vaccines Administered With a MVA-CMDR Boost Vaccine in Healthy, HIV-Uninfected Adults

Summary

The purpose of this study is to evaluate the safety and immune response to three DNA vaccines and a MVA-CMDR vaccine that may boost the immune response to the DNA vaccines in healthy, HIV-uninfected adults.

Conditions

• HIV Infections

Interventions

BIOLOGICAL

DNA Nat-B env

4 mg to be administered as 1 mL intramuscularly (IM) by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

BIOLOGICAL

DNA CON-S env

4 mg to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

BIOLOGICAL

DNA Mosaic env

4 mg to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

BIOLOGICAL

MVA-CMDR

1×10\^8 plaque forming units (pfu) to be administered as 1 mL IM in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

BIOLOGICAL

Placebo for DNA Nat-B env

Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

BIOLOGICAL

Placebo for DNA CON-S env

Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

BIOLOGICAL

Placebo for DNA Mosaic env

Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

BIOLOGICAL

Placebo for MVA-CMDR

Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

Sponsors & Collaborators

• CHAVI

  collaborator UNKNOWN

• IPPOX Foundation

  collaborator OTHER

• MHRP

  collaborator UNKNOWN

• HIV Vaccine Trials Network

  collaborator NETWORK

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Lindsey Baden · Brigham and Women's Hospital

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

2014-12-31

Primary Completion

2016-11-30

Completion

2020-07-06

Countries

• United States
• Switzerland

Study Locations