A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya
Status:
Recruiting
Trial end date:
2023-02-08
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
The Emmes Company The Emmes Company, LLC US Army Medical Research Directorate-Africa US Military HIV Research Program Walter Reed Army Institute of Research (WRAIR)