A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya

Summary

This is a study of HIV vaccines. A vaccine is a medical product given to prevent certain diseases. The vaccine may educate the body to form a defensive response to try to prevent the disease from the beginning, or preventing it from taking hold of the body. This defensive response is called the immune response. The experimental vaccines in this study are Env-C Plasmid DNA and HIV Env gp145 C690 protein, given with different adjuvants. An adjuvant is a substance added to vaccines that can help make the vaccine more effective by improving the immune response, or by causing the immune response to last longer than it would without the adjuvant. The adjuvants are mixed with the vaccines and injected into muscle or placed on top of the skin. The HIV vaccines contain a piece of genetic material or a protein copied drom the HIV virus cover (Env), but they do not contain the virus itself. The vaccines cannot cause HIV infection or Acquired Immune Deficiency Syndrome (AIDS).

The purpose of this study is to find out if the study vaccines with adjuvants cause side effects and are tolerable, whether humans respond (develop immune responses) to the vaccines, and how ling the effects of the study vaccines last. The study will also compare the effects of the study vaccines with adjuvants and adjuvant patch to those of placebo injections and placebo patch. The placebo will consist of saline (sterile saltwater) and will look like study vaccines, be given in the same way, but will have no active vaccine or adjuvant in it. A total of 126 participants will take part in the study and each will have up to 26 clinic visits and will be followed-up for a total of 108 weeks.

Conditions

• HIV Infections

Interventions

DRUG

Placebo (TCl)

Transcutaneous application (needle-free skin patch). 0.9% sodium chloride (sterile saline) added to gauze pad at site of injection.

BIOLOGICAL

Env-C Plasmid DNA

2 mg per dose. Administered by intramuscular injection.

BIOLOGICAL

HIV Env gp145 C.6980 protein

100 µg per dose. Administered by intramuscular injection.

DRUG

Rehydragel®

Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.

BIOLOGICAL

ALF43

Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.

BIOLOGICAL

dmLT

Adjuvant. Recombinant double mutant Escherichia coli heat labile toxin. 50 µg per dose. Transcutaneous application (needle-free skin patch). 1 mL diluted dmLT added to gauze pad at site of injection.

DRUG

Placebo (IM)

0.9% sodium chloride (sterile saline). Administered by intramuscular injection.

Sponsors & Collaborators

• Walter Reed Army Institute of Research (WRAIR)

  collaborator FED

• US Military HIV Research Program

  collaborator NETWORK

• The Emmes Company, LLC

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Josphat Kosgei, MBChB, MSc · Kenya Medical Research Institute/US Medical Research Directorate-Africa

• Christina Polyak, MD · U.S. Military HIV Research Program (MHRP)/Walter Reed Army Institute of Research (WRAIR)

• Sandhya Vasan, MD · U.S. Military HIV Research Program (MHRP)/Walter Reed Army Institute of Research (WRAIR)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-15

Primary Completion

2024-02-13

Completion

2024-02-13

FDA Drug

Yes

Countries

• Kenya

Study Locations