Transcript HVTN 107
HVTN 107 A Zimbabwe Update Dr Portia Hunidzarira Annual Research Day 17 April 2015 Presentation outline • Background • HVTN 107 study design • Preparatory work in Zimbabwe for HVTN 107 • Current status for study initiation 7/16/2015 2 Background • HIV vaccine research worldwide has been ongoing for about 30 years. • Since 1985, more than 30 vaccine candidates have been tested in 80 clinical trials. Only 4 of these have proceeded to efficacy trials. • There is still no licensed vaccine against HIV. • RV144 Thai trial was the first ever large scale vaccine study to show that a HIV vaccine can actually work. • HVTN 107 will be the first HIV vaccine trial in Zimbabwe. HVTN 107 Study design • Phase 1/2a,multicenter, double blind, randomised trial. • 132 participants in total across 3 countries Mozambique, Zimbabwe & South Africa. • Zimbabwe will enroll 26 participants (about 20% of the total) 7/16/2015 4 Vaccine candidate • The 2-Vaccine combination used in the RV144 trial has been modified to match HIV subtype C found in Southern African region. • 2 HIV vaccines 1. Prime: ALVAC-HIV (vCP2438) pox 2. Boost: Bivalent Subtype C gp120 protein • 2 adjuvants 1. MF59® 2. Aluminium hydroxide 7/16/2015 5 Vaccine description • ALVAC-HIV (vCP2438) is a man-made weakened canarypox virus vector carrying genes copied from HIV-1 to safely deliver them to the body’s immune cells. • Bivalent Subtype C gp120 is a lab-made protein with 2 subunits copied to look like the subtype C HIV Env surface glycoproteins. • Adjuvants are products used to boost the body’s reaction to the vaccine. • Alum adjuvant has been used for years in vaccines like Diphtheria, pertussis, tetanus and anthrax • MF59® is a newer adjuvant and is being used in licensed vaccines for flu & hepatitis B 7/16/2015 6 Main objectives of study • To compare the humoral immune responses induced by the MF59®- and alum-adjuvanted vaccine regimens • To evaluate the safety and tolerability of each vaccine regimen • To further evaluate the humoral and cellular systemic immune responses to the different vaccine regimens 7/16/2015 7 Eligibility for study Male and female adults aged 18-40yrs Low risk for HIV infection HIV negative General good health shown by medical history, physical exam and screening laboratory tests. • Willing to give an informed consent • Women not pregnant/breastfeeding & on a reliable contraceptive • • • • 7/16/2015 8 HVTN 107 Vaccination schedule Additional prime boost given at 12 months unlike the RV144 regimen 0 1 3 6 12-month vaccination schedule 12 18 24 30 36 ALVAC-HIV (vCP2438) priming Bivalent Subtype C gp120 boosting + adjuvants Vaccine-induced seropositivity (VISP). • Experimental HIV vaccines may induce Ab production to HIV antigens, producing reactive results on commercially available HIV test kits. • Volunteers who develop VISP will be registered and followed for specialised HIV testing by the HVTN laboratory. 7/16/2015 10 Stakeholder Engagement • Community Advisory Board • Chitungwiza HS • Regulators Bodies • Training • Pre-submission discussions • Ministry of Health and Child Care • • • • Epidemiology and Disease Control AIDS and TB Unit Permanent Secretary for Health Minister of Health and Child Care Seke South CRS Renovations Start date of HVTN107 • The protocol team are working to revise the HVTN 107 protocol and it should be released to us later this month • Regulatory submissions and reviews underway • Study vaccines available from manufacturers from August 2015 7/16/2015 13 7/16/2015 14