RV 460
Status:Ongoing
Phase:I
Principal Investigator(s):Josphat Kosgei
Objective:A Randomized, Double-Blind Phase 1 Trial to Evaluate the Safety and Immunogenicity of Priming With Env-C Plasmid DNA Vaccine Alone, With Different Adjuvants, or With an Adjuvanted HIV Env gp145 C.6980 Protein Vaccine and Boosting With the Adjuvanted HIV Env gp145 C.6980 Protein Vaccine With or Without the Env-C Plasmid DNA Vaccine in Healthy HIV Uninfected Adults in Kenya
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).
Last updated September 19, 2022
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Group 1: Vaccine or Placebo
3 doses of prime vaccination or placebo at weeks 0, 4, 12 followed by 3 doses of boost vaccination or placebo at weeks 20, 32, 56
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: Group 2: Vaccine or Placebo
3 doses of prime vaccination or placebo at weeks 0, 4, 12 followed by 3 doses of boost vaccination or placebo at weeks 20, 32, 56
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: Group 3: Vaccine or Placebo
3 doses of prime vaccination or placebo at weeks 0, 4, 12 followed by 3 doses of boost vaccination or placebo at weeks 20, 32, 56
Mode of DeliveryIntermuscular, Intradermal
ARMsExperimental
DescriptionExperimental: Group 4: Vaccine or Placebo
3 doses of prime vaccination or placebo at weeks 0, 4, 12 followed by 3 doses of boost vaccination or placebo at weeks 20, 32, 56
Mode of DeliveryIntradermal, Intramuscular
ARMsExperimental
Official Code:
NCT04826094
Trial Sponsors:
NIAID, US Army Medical Research Directorate-Africa, US Military HIV Research Program, WRAIR
Start Date
End Date
March 16, 2021
February 8, 2023
Enrollment:126
Age range:
18 Years ↔
40 Years
Population:Cisgender Men, Cisgender Women