Pharmacy and Poisons Board: Applications

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Protocol No:

ECCT/13/07/01

Date of Protocol:

15-04-2013

Study Title:	A phase I/IIa clinical trial of universal HIV-1 vaccines pSG2.HIVconsv DNA, MVA.HIVconsv and ChAdV63.HIVconsv in combined regimens in healthy HIV-1/2-negative adults in Nairobi.
	Change in Title to : A phase I/IIa clinical trial of HIV-1 vaccines pSG2.HIVconsv DNA, MVA.HIVconsv and Ad35-GRIN in combined regimens in healthy HIV-1/2-negative adults in Nairobi. (HIV-CORE004 Version 4 Dated 15^th October, 2013)
Study Objectives:
Laymans Summary:
Abstract of Study:	Background: The development of an effective, accessible vaccine is the only realistic hope for halting the human immunodeficiency virus type 1 epidemic. Ideally, such a vaccine should induce broadly neutralizing antibodies and effective T cells at the same time; however, both of these goals face substantial and very different challenges. A rational scientific strategy tackles and solves these roadblocks separately before combining the two successful solutions into a single vaccine formulation. This study focuses on induction of effective T cells. Method: We propose to conduct a Phase 1/IIa randomized, placebo-controlled, double-blind clinical trial in HIV-uninfected healthy adult volunteers at low-risk for HIV infection to evaluate the safety, tolerability and immunogenicity of the three vaccines pSG2.HIVconsv DNA (D), ChAdV63.HIVconsv (C) and MVA.HIVconsv (M) in Kenya using CM and DDDCM regimens. Primary Objectives To evaluate the safety of the pSG2.HIVconsv DNA, ChAdV63.HIVconsv and MVA.HIVconsv vaccines administered sequentially by intramuscular needle injection in heterologous prime-boost regimens into healthy, low-risk, HIV-1-uninfected adult volunteers. Secondary Objectives To evaluate the immunogenicity of the pSG2.HIVconsv DNA, ChAdV63.HIVconsv and MVA.HIVconsv vaccines administered sequentially by intramuscular needle injection in two different heterologous prime-boost regimens into healthy, low-risk, HIV-1-uninfected adult volunteers. To compare the immunogenicity (breadth, specificity and HIV-1 clade coverage of T cell responses) of two regimens DDDCM and CM. To determine whether priming with three DNA vaccinations (DDDCM regimen) affects the frequency, durability and/or quality of T cell responses to the HIVconsv immunogen by comparing responses to the DDDCM and CM regimens. Study Population: The study population consists of healthy male or female adults aged 18-50 years at low risk for HIV infection, who are willing to undergo HIV testing, use an effective method of contraception, and who in the opinion of the investigator or designee, understand the study and provide written informed consent. Approximately 48 volunteers (40 vaccine recipients, 8 placebo recipients) who meet all eligibility criteria will be included in the study.
1	Background: The development of an effective, accessible vaccine is the only realistic hope for halting the human immunodeficiency virus type 1 epidemic. Ideally, such a vaccine should induce broadly neutralizing antibodies and effective T cells at the same time; however, both of these goals face substantial and very different challenges. A rational scientific strategy tackles and solves these roadblocks separately before combining the two successful solutions into a single vaccine formulation. This study focuses on induction of effective T cells. Method: We propose to conduct a Phase 1/IIa randomized, placebo-controlled, double-blind clinical trial in HIV-uninfected healthy adult volunteers at low-risk for HIV infection to evaluate the safety, tolerability and immunogenicity of the three vaccines pSG2.HIVconsv DNA (D) with or without electroporation (EP), AD35GRIN (A) and MVA.HIVconsv (M) in Kenya using AM, DDDAM and D(EP)D(EP)D(EP)AM regimens. Primary Objectives To evaluate the safety and tolerability of candidate HIV-1 vaccines pSG2.HIVconsv DNA (with or without electroporation), AD35-GRIN and MVA.HIVconsv vaccines administered intramuscularly as part of heterologous prime-boost regimens. Secondary Objectives To evaluate the magnitude, specificity and quality of HIV-1 specific T cell responses after administration of pSG2.HIVconsv DNA (with or without electroporation), AD35-GRIN and MVA.HIVconsv vaccines in heterologous prime-boost regimens. To evaluate the acute tolerability of the electroporation procedure Study Population: The study population consists of healthy male or female adults aged 18-50 years at low risk for HIV infection, who are willing to undergo HIV testing, use an effective method of contraception, and who in the opinion of the investigator or designee, understand the study and provide written informed consent. Approximately 72 volunteers (60 vaccine recipients, 12 placebo recipients) who meet all eligibility criteria will be included in the study.