HIV Vaccine. 15 September 2016 นพ.นคร เปรมศร ผ อ านวยการส าน กงาน โครงการศ กษาว คซ นเอดส ทดลอง

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1 HIV Vaccine 15 September 2016 นพ.นคร เปรมศร ผ อ านวยการส าน กงาน โครงการศ กษาว คซ นเอดส ทดลอง

2 GLOBAL STATISTICS million people were accessing antiretroviral therapy 36.7 million people globally were living with HIV 2.1 million people became newly infected with HIV 1.1 million people died from AIDS-related illnesses 78 million people have become infected with HIV since the start of the epidemic 35 million people have died from AIDS-related illnesses since the start of the epidemic

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6 Global Subtype Distribution of HIV-1 Subtype E (CRF01_AE) = 5% global

7 National Plan for HIV/AIDS Vaccine Development Developed by Thai MOPH and research scientists with GPA/WHO collaboration Approved by NAC and launched in 1993 placing HIV vaccine research and development on the fast track Aimed at research and development of safe, effective, affordable and accessible HIV vaccines for the Thai people at the earliest possible date

8 Challenges in HIV vaccine Development No natural clearance of HIV from human body & no immunity to prevent repeated infection Genetic changes in every duplication Antigen surface covered by sugar Attacking the immune system : too fast, too furious No animal model: HIV- human, SIV- monkey

9 Hope in HIV vaccine Development Long term negative couple discordant, CSW without prevention Long term non-progressor (Elite controller) Many years with low level of viral load among general infected people Live attenuated SHIV Vaccine can prevent infection in macaque.

10 Challenges in HIV vaccine Development No natural clearance of HIV from human body & no immunity to prevent repeated infection Genetic changes in every duplication Antigen surface covered by sugar Attacking the immune system : too fast, too furious No animal model: HIV- human, SIV- monkey

11 Hope in HIV vaccine Development Long term negative couple discordant, FSW without prevention Long term non-progressor (Elite controller) Many years with low level of viral load among general infected people Live attenuated SHIV Vaccine can prevent infection in macaque.

12 HIV Structure gp120

13 แนวค ดการพ ฒนาว คซ นเอดส Prime Vac. ALVAC (sanofi) Boost Vac. AIDSVAX (GSID) gp120

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15 Study Vaccines RV144 ALVAC -HIV (vcp1521) Recombinant canarypox vector vaccine genetically engineered to express HIV-1 gp120 (subtype E: 92TH023) linked to the transmembrane anchoring portion of gp41 (subtype B: LAI), and HIV-1 gag and protease (subtype B: LAI). AIDSVAX B/E Bivalent HIV gp120 envelope glycoprotein vaccine containing a subtype E envelope from the HIV-1 strain CM244 and a subtype B envelope from the HIV-1 strain MN.

16 Vaccination and Follow-up Schedule HIV test, risk assessment and counseling (time in years) 6-month vaccination schedule 3 years of follow-up (every 6 mo.) ALVAC -HIV (vcp1521) priming at week 0, 4, 12, 24 AIDSVAX B/E gp120 boosting at week 12, 24

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21 ผลของว คซ น ม แนวโน มประส ทธ ผลท น าสนใจอย างย ง ç ð f bē fi ćĉfi c hè ê ff 80% 70% 60% 50% 40% 30% 20% 10% 0% Modified intent-to-treat 68% Per-protocol 60% 36% 31% N/A fį ǽf ē ffć

22 RV144 Follow-up Immunogenicity Studies RV305 Evaluating re-boosting at Month 0, 6 with AIDSVAX, ALVAC, or combination in volunteers who received RV144 vaccination Intensive systemic and mucosal immunogenicity data Started May 2012; n=162 All vaccinations complete; initial immunogenicity results RV306 RV144 vaccine regimen + month 12, 15 or 18 boost with ALVAC, AIDSVAX, or combination Intensive systemic and mucosal immunogenicity data Started 24 September 2013 (Mahidol day); n=360 (49 screened by Oct 7) RV328 AIDSVAX B/E only for intense immunologic assessments Start early 2014; n=40

23 RV305 Vaccination Schedules RV144 months Vaccine Recipients RV306 (additional Boost) ALVAC -HIV (vcp1521) or placebo AIDSVAX B/E gp120 or placebo No Boost RV305 >> N= receive active vaccine per arm 9 placebo per arm months 0 6 RV305 Start

24 Follow up Studies RV144 months Vaccine Recipients RV306 (additional Boost)

25 RV144 s Series of HIV Vaccine Development in Thailand RV RV RV305/306/ RV348 Efficacy 31.2% 1 st ever efficacious HIV Vaccine IgG to V2 ADCC Correlates of Risk Bench Mark for New candidates Additional Booster Late Booster Immunogenecity Study Cohort Study MSM Nakhon-Rajasima Ratch Buri Bangkok Preparation for next gen of HIV Vaccine

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32 Vax 004 VAX 003 Recombinant gp120 (B/B) Recombinant gp120 (B/E) No No STEP RV144 HVTN 505 P5 rad5 (B) Canary Pox (E) Recombinant gp120 (B/E) DNA, rad5 (A/B/C) Canary Pox (C) Recombinant gp120 (C/C) No Yes (31%) No?

33 On the way forward New generation HIV Vaccines Prime-Boost Concept Immune Response / Correlates of Risk Better Immunogenicity Vaccine Candidates Broad Spectrum of Antigenicity Thailand should remain commitment and continue collaborative works

34 ขอบค ณคร บ