RSA & HIV vaccine efficacy studies. Glenda Gray 15 March 2016
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1 RSA & HIV vaccine efficacy studies Glenda Gray 15 March 2016
2 3 strategies that are advancing Efficacy Studies P5 Clade C approach using ALVAC & gp120/mf59 (HVTN 702) Multi-clade approach using rad26/mva/gp140 trimer Neutralising antibody approaches
3 Thai Trial (RV144) Primary Results Prime: Boost: ALVAC vcp1521 ALVAC vcp1521 plus VAXGEN Env protein (B/E) Schedule: 0,1,3,6 months; 16,000+ volunteers; 1:1 vaccine: placebo; follow-up for 3 years 1.0 Modified Intention to Treat Analysis 0.9 Probability of HIV Infection (%) Placebo Vaccine Years Data from Robb et al, Lancet Infectious Diseases, 2012.
4 The Strategy for the ALVAC/Protein Phase 3 Program Construct ALVAC-HIV-C (vcp2438) Construct Bivalent Subtype C gp120/mf59 Add Booster at 12 months Optimize regimen for regional relevance, increased potency, and durability
5 HVTN 100 Primary objectives To evaluate the safety and tolerability of 2 doses of ALVAC HIV (vcp2438) followed by 2 doses of ALVAC HIV (vcp2438) + Bivalent Subtype C gp120/mf59 in HIV seronegative low risk South African adults To evaluate the immunogenicity of 2 doses of ALVAC HIV (vcp2438) followed by 2 doses of ALVAC HIV (vcp2438) + Bivalent Subtype C gp120/mf59 in HIVseronegative low risk South African adults at the month 6.5 timepoint (2 weeks after completion of the primary immunization series)
6 HVTN 100 Schema Group N Primary vaccine regimen Booster Month 0 Month 1 Month 3 Month 6 Month ALVAC-HIV (vcp2438) ALVAC-HIV (vcp2438) ALVAC-HIV (vcp2438) + Bivalent Subtype C gp120/mf59 ALVAC-HIV (vcp2438) + Bivalent Subtype C gp120/mf59 ALVAC-HIV (vcp2438) + Bivalent Subtype C gp120/mf Placebo Placebo Placebo + Placebo Placebo + Placebo Placebo + Placebo Total 252
7 HVTN 100 Clinic Sites Soweto--Baragwanath Shoshanguve Klerksdorp ethekwini and Isipingo Cape Town Emavundleni
8 HVTN 100 Current Status Primary vaccination series (Months 0, 1, 3, 6) complete for all participants Follow up ongoing Booster vaccinations (Month 12) just beginning Primary immunogenicity assays (Month 6.5 samples) ongoing Interim safety and immunogenicity analyses (to Month 6.5) in process
9 Go Decision Timeline
10 HVTN 100 Go/No-Go Criteria for HVTN 702: Must Meet all of the Following Conditions Variable Measured at Month 6.5 Env Ab Response Rate ( 2 of 3) Env Ab Magnitude* ( 2 of 3) Env CD4 Response Rate* (1 of 1) Env V1V2 Response Rate ( 1 of 3) Rationale Adequate Ab take to vaccine Env Non-inferior Ab magnitude vs. RV144 Non-inferior CD4 T cell take vs. RV144 Adequate to predict achieving VE=50% for 2 years if V1V2 Ab is an immune correlate * Based on assessment of immune responses from HVTN 100 vaccinees vs. RV144 vaccinees using the same assays run in the same labs
11 Primary objectives HVTN 702 To evaluate the preventive vaccine efficacy (VE) of ALVAC HIV (vcp2438) + Bivalent Subtype C gp120/mf59 for the prevention of HIV infection in HIV seronegative South African adults over 24 months from enrollment To evaluate the safety and tolerability of ALVAC HIV (vcp2438) + Bivalent Subtype C gp120/mf59 in adults in South Africa
12 HVTN 702 Schema Group N Primary vaccine regimen Booster Month 0 Month 1 Month 3 Month 6 Month ALVAC-HIV (vcp2438) ALVAC-HIV (vcp2438) ALVAC-HIV (vcp2438) + Bivalent Subtype C gp120/mf59 ALVAC-HIV (vcp2438) + Bivalent Subtype C gp120/mf59 ALVAC-HIV (vcp2438) + Bivalent Subtype C gp120/mf Placebo Placebo Placebo + Placebo Placebo + Placebo Placebo + Placebo Total 5400
13 HVTN 702 Design Features (i) Evaluates Stage 1 vaccine efficacy (VE) to 24 months after 1 st vaccination If evidence of positive VE, evaluates VE durability to 36 months after 1 st vaccination Continuous monitoring for harm Sequential monitoring for non efficacy/ efficacy futility Monitoring for high efficacy
14 HVTN 702 Design Features (ii) 90% power to detect Vaccine Efficacy (VE) of 50% (enrollment through 24 months) = 90% power to reject null hypothesis (VE 25%) True Average VE(0-24) Power to reject null: VE(0-24) 25% 30% 7 40% 45 50% 90 60% % % 100
15 HVTN 702 Clinic Sites Rustenberg Brits Shoshanguve Medunsa Soweto Baragwanath Soweto--Kliptown Tembisa Klerksdorp Ladysmith ethekwini Isipingo Verulam Cape Town Emavundleni Cape Town--Khayelitsha Mthatha
16 HVTN 702 Partnership Bill & Melinda Gates Foundation Division of AIDS, National Institute of Allergy and Infectious Diseases, US National Institutes of Health GlaxoSmithKline Vaccines HIV Vaccine Trials Network Medical Research Council of South Africa Sanofi Pasteur
17 3 strategies that are advancing Efficacy Studies P5 Clade C approach using ALVAC & gp120/mf59 (HVTN 702) Multi-clade approach using rad26/mva/gp140 trimer Neutralising antibody approaches
18 HIV vaccine research program: Janssen and Collaborators BIDMC Harvard MHRP IAVI Ragon NIAID/HVTN
19 HIV Vaccine Aiming at Protection Against all Clades of HIV-1 Different HIV-1 clades dominate in different geographic regions Adolescents (11-17 years) /Adults (18-65 years) in endemic countries and populations at risk in Western world Potent priming Vectors Low seroprevalent Ad26 Ad26.HIV-Gag-Pol Ad26.HIV-Env (MVA.HIV-Gag-Pol-Env) Mosaic inserts for global coverage Trimeric env protein for improved humoral immunity Dan H Barouch et al, 2013 Dan H Barouch et al.,
20 A prime-boost vaccine regimen aiming at global coverage starting Prime Boost Ad26 Mosaic vectors gag-pol-env Ad26 Mosaic vectors gag-pol-env +/- Soluble trimer gp140 env protein Ad26 Mosaic vectors gag-pol-env MVA Mosaic vectors gag-pol-env or +/- Soluble trimer gp140 env protein months
21 Ad26/Env SIV Vaccines Partially Protect Against IR SIVmac251 Challenges in Rhesus Monkeys 90% reduction of per exposure acquisition risk for Ad/Env (P=0.001) 50% (6 of 12) show complete protection for Ad/Env (P=0.01) 32 rhesus monkeys Ad26/Env (N=12) Ad26/Ad35 (N=12) Sham (N=7) Repetitive, intrarectal, heterologous SIVmac251 challenges Correlates of protection ELISA P < Ab Funct P = NAb P = NS Barouch et al. Science 2015
22 3 strategies that are advancing Efficacy Studies P5 Clade C approach using ALVAC & gp120/mf59 (HVTN 702) Multi-clade approach using rad26/mva/gp140 trimer Neutralising antibody approaches
23 Neutralizing Ab to HIV-1 V3-glycan gp41 MPER V1V2-glycan CD4 binding site gp120/41 interface V1V2-Glycan bind to trimer cap V3-glycan, N332 supersite gp41 MPER near membrane gp120/41 interface bind to parts of both gp120 and gp41 CD4 binding site of gp120 where the virus attaches to CD4 Christina Corbaci, Andrew Ward, Only antibodies that have advanced the clinic (VRC01, 3BNC117)
24 VRC01 Protects Against Mucosal SHIV-Challenge in Non-Human Primates 20 mg/kg infusion of VRC01: Challenge with SHIV SF162P3 RECTAL CHALLENGE VAGINAL CHALLENGE 100 4/4 protected 100 4/4 protected Percent uninfected VRC01 Control 0/4 protected Percent uninfected /4 protected VRC01 Control Days post challenge Days post challenge Pegu et al. Science Transl Med (2014) Ko et al. Nature (2014) Rudicell et al. J Virol (2014) 24
25 AMP Trial Objectives 1. To determine whether and how the VRC01 broadly neutralizing mab can prevent HIV infection 2. To develop a marker(s) of VRC01 that correlates with the level of protection against HIV infection 3. To provide insight into the mechanistic correlates of protection Application: Help design candidate HIV vaccines and define immunogenicity study endpoints in Phase I/II trials for evaluating these candidate vaccines
26 AMP: Two Phase IIB Studies HVTN 703/HPTN 081 will enroll 1,500 women in sub-saharan Africa HVTN 704/HPTN 085 will enroll 2,700 MSM and transgender persons in the Americas Each ppt. will be randomized to receive VRC01 10 mg/kg or 30 mg/kg or placebo every 8 weeks for 10 doses
27 Major Scientific Questions and Issues the Trial will Define Do immunogens that elicit lower levels of neutralization, levels that have proven protective in NHP challenge models, protect against HIV acquisition in humans? What is the dynamic range in concentration of antibodies and neutralizing activity associated with protection? Can lower levels of neutralization activity afford protection or does in vivo protection require only high concentrations of CD4 binding site antibodies? Are non-neutralizing effector functions as predictive of efficacy as neutralizing activity? What are the kinetics and functional (non-neutralizing) activities that are seen at low levels of neutralization for VRC01?
28 AMP Research Sites
29 AMP sub-saharan Africa Sites Gabarone, Botswana Kisumu, Kenya Blantyre, Malawi Lilongwe, Malawi Maputo, Mozambique Harare (3 clinics), Zimbabwe Cape Town, RSA Durban (2 clinics), RSA Johannesburg, RSA Soweto, RSA Vulindlela, RSA Mbeya, Tanzania
30 Timeline for AMP in sub-saharan Africa: Open April 2016 AMP sub-saharan Africa Dates DAIDS Reviews 2/1/2016-3/21/2016 MCC and RSA EC Reviews 10/2015-2/2016 RSA Community & Protocol Trainings 2/2016-3/2016 Trial Opens* 4/1/2016 *Additional SSA National Regulatory Authority & EC reviews continue to Q3 2016, with trainings to be scheduled accordingly.
31 Enrollment Projections: AMP in sub-saharan African women
32 Acknowledgements IAS Ken Mayer HVTN Larry Corey VRC John Mascola Barney Graham & Funders: NIAID/BMGF/SAMRC J&J/Janssen Dan Barouch Nelson Michael Frank Tomaka NICD Lynn Morris HPTN Mike Cohen
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