Evaluating the Safety and Immune Response to Three Different Prime-Boost HIV Vaccine Regimens in Healthy, HIV-Uninfected Adults

Summary

The purpose of this study is to test the safety and immune response to three different sets of HIV vaccines in healthy, HIV-uninfected adults.

Conditions

• HIV Infections

Interventions

BIOLOGICAL

DNA Nat-B env vaccine

The DNA Nat-B env vaccine will be administered as a 4-mg dose injection intramuscularly (IM) by Biojector 2000 ® in the deltoid muscle of the non-dominant arm (unless medically contraindicated).

BIOLOGICAL

NYVAC Nat-B env vaccine

NVYAC Nat-B env vaccine will be administered as a 3 × 10\^7 plaque forming units (pfu) dose IM by needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated).

BIOLOGICAL

DNA CON-S env vaccine

The DNA CON-S env vaccine will be administered as a 4-mg dose injection IM by Biojector 2000 ® in the deltoid muscle of the non-dominant arm (unless medically contraindicated).

BIOLOGICAL

NYVAC CON-S env vaccine

NVYAC CON-S env vaccine will be administered as a 3 × 10\^7 pfu dose IM by needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated).

BIOLOGICAL

DNA Mosaic env vaccine

The DNA Mosaic env vaccine will be administered as a 4-mg dose injection IM by Biojector 2000 ® in the deltoid muscle of the non-dominant arm (unless medically contraindicated).

BIOLOGICAL

NYVAC Mosaic env vaccine

NVYAC Mosaic env vaccine will be administered as a 3 × 10\^7 pfu dose IM by needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated).

BIOLOGICAL

Placebo

Placebo for both DNA and NYVAC vaccines will be administered in the deltoid muscle of the non-dominant arm (unless medically contraindicated) as sodium chloride for injection, 0.9%.

DEVICE

Biojector 2000® Needle-Free Injection Management System™ (Biojector 2000®)

All three DNA env vaccines will be administered IM in the deltoid muscle of the non-dominant arm (unless medically contraindicated) using the Biojector 2000® device.

Sponsors & Collaborators

• HIV Vaccine Trials Network

  collaborator NETWORK

• IPPOX Foundation

  collaborator OTHER

• Center for HIV/AIDS Vaccine Immunology (CHAVI)

  collaborator UNKNOWN

• 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

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Primary Completion

2018-08-31