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ALVAC®-HIV (Vcp1521) Priming at Week 0, 4, 12, 24

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ALVAC®-HIV (Vcp1521) Priming at Week 0, 4, 12, 24 Vaccine Trial Centre Established in1984 Funded by WHO on Control of Diarrhea Diseases Full operation in1986 Past 29 Years of Research Experiences • Cholera Vaccine Killed whole cell and B sub-unit oral vaccine CVD103-Hg resistant oral vaccine • Rotavirus Vaccine- Rotashield (tetravalent oral vaccine) • Poliomyelitis Vaccine (OPV & IPV) • Malaria Vaccine Varicella Vaccine • Measles Vaccine Cholera challenge-O1, O139 • WRSS1 Shigella Vaccine • HPV quadri-valent vaccine, nona- valent vaccine • H1N1 LAIV vaccine (WHO) H5N2 LAIV Vaccine (WHO) HIV Vaccine rgp 120 B, rgp 120 B/E ALVAC HIV Vaccine & rgp 120 B/E (Phase I/ II and III (RV144) RV305 RV306 Collaboration • AFRIMS – US, Thai • MHRP Military HIV Research Program • MOPH • Chulalongkorn University • Chiangmai University VTC Project Timeline 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 11 12 13 14 Projects Elderly flu vaccine RV306 GPO Avian Flu Vaccine-V02 RV305 Dengue CYD14 Dengue CYD34 V503-002 Nonavalent HPV vaccine in Preadolescents and Adolescents live attenuated influenza vaccine (PLAIV) V503-001 Nonavalent HPV vaccine Safety, Immunogenicity and Efficacy Studies of WRSS1 Measurement of Anogenital Wart Burden and Cost of Illnesses Herpes Zoster and Post-Herpetic Neuralgia Associated Establishment of a Shigella sonnei Challenge Model for Evaluation HIV-1 CM235 env/CM240 gag/pol vaccine HIV-1 gag DNA with or without IL-12 DNA Assessing the psychosocial burden in woman with abnormal pap Efficacy of GARDASIL™ in mid adults, HPV vaccine MRKAd5 HIV-1 vaccine ALVAC-HIV vaccine + gp 120 B/E vaccine boost Immunogenicity and Safety of Quadrivalent, HPV vaccine in young adults ALVAC-HIV vaccine + oligo gp 160 or gp 120 B/E vaccine boost ALVAC-HIV vaccine + gp 120 B/E vaccine boost Cholera Challenge in volunteers using frozen V.cholera 0139 bacteria AIDSVAX B/E gp 120 alum subtype B/E (AIDSVAX B/E) gp 120 MF 59 subtype B alone or with subtype E gp 120 alum subtype B Total-27 Phase I/II trials Phase III trials Surveillance Publications during 2004-2013 16 14 Total = 75 12 10 8 6 Number of publications of Number 4 2 0 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 year Most Cited Publications (Publications during 2004-2013) 79 Vaccine 2010; 28(4):950-7. 104 J Infect Dis 2004; 190:702-6. 137 Clin Infect Dis 2006; 42(12):1726-34. 143 J Antimicrob Chemother 2005; 56:745-755. 185 PLoS Med 2005; 2(10):390. 185 J Virol 2009; 83(14):7337-48. 266 Lancet 2009; 373(9679):1949-57. 294 N Engl J Med 2012;366(14):1275-86. 416 J Infect Dis 2006; 194(12):1661-1671. 663 Science 2009; 326(5950):285-9. 1274 N Engl J Med 2009; 361(23):2209-20. HIV-1 Vaccine Clinical Trials in Thailand 1) Injecting Drug users (IVDUs) A. 1995 Phase I/II AIDSVAXTM monovalent vaccine B. 1998 Phase I/II AIDSVAXTM B/E bivalent vaccine C. 1999 -2003 Phase III AIDSVAXTM B/E vaccine 2) Healthy, Community participation A. 1998 Phase I/II Chiron gp120/MF59 subtype E antigen alone or combined with B antigen B. 2000 Phase I/II ALVAC vaccine(vCP1521) prime AIDSVAXTM vaccine boost C. 2003- 2009 Phase III of AlVAC priming and AIDSVAX boosting (RV144) D. 2003- 2009 Phase I MRK HIV-I Vaccine E. 2012-2014 RV305 F. 2013- RV306 AIDSVACCINE Trial IN THAILAND 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 11 12 13 RV306 RV305 HIV-1 CM235 env/CM240 gag/pol vaccine HIV-1 gag DNA with or without IL-12 DNA pHIS-HIV-AE (DNA) and rFPY-HIV-AE MRKAd5 HIV-1 vaccine ALVAC-HIV vaccine + gp 120 B/E vaccine boost ALVAC-HIV vaccine + oligo gp 160 or gp 120 B/E vaccine boost ALVAC-HIV vaccine + gp 120 B/E vaccine boost AIDSVAX B/E gp 120 alum subtype B/E (AIDSVAX B/E) gp 120 MF 59 subtype B alone or with subtype E gp 120 alum subtype B gp 120 MF 59subtype B Peptide V3-MAPS PREVENT ESTABLISHED INFECTION? ***** Immune responses against HIV Jhonston M and Fauci A. NEJM,2007,May17;356(20):2073-81 Scientific and Non-scientific Obstacles to the Development of an HIV Vaccine • Clearance of HIV in an HIV-infected individual has not been demonstrated, suggesting that the innate and adaptive immune defense system cannot overcome the virus. • Extensive viral subtype and sequence diversity limits the efficacy of current vaccine approaches to specific subtypes. • Rapid changes in HIV genetic sequences as well as phenotypic features allow HIV to escape from immune suppression. Source: Adapted from Barouch (2008) • Super infection suggests that immune responses induced by one virus have no protective activity against the subsequent infection. • There is a narrow window of opportunity for the immune system to clear initial infection before establishment of latent viral reservoirs. • Immune correlates of protection remain poorly understood. • Viral escape from humeral and cellular immune responses may limit sustained efficacy. Source: Adapted from Barouch (2008) Obstacles to the Development of an HIV Vaccine • Conserved antibody targets on the outer envelope protein are hidden. • Appropriate animal models that can truly predict efficacy in humans are lacking. • The interest of the pharmaceutical industry is limited. • Long-term sustained commitment from governments and donors is limited. Source: Adapted from Barouch (2008) Recombinant protein (gp120) AIDSVAX B/B’ or B/E DNA Live-recombinant vectors • Using Ad5 Virus –MRKAd5 • Or ALVAC virus (bird pox virus) ALVAC HIV vaccine Efficacy studies thus far Study Year Population Vaccine Vaccine Efficacy IDUs(Thailand) VAX Vax003-0.1% 1997-02 MSM(North AIDSVAX 003,004 (95% CI:30.8%-23.8%) America) 24/741 V became HIV-1 infected VS Seronegative high STEP 2005-07 MRKAd5 21/762 P risk voulnteers, Hazard ratio 1.2 US (95% CI 0.6-2.2) ALVAC, 31.2% RV144 2003-09 Community risk (95% CI: 1.1-51.2 AIDSVAX Thailand p-value: 0.04) HIV-negative men 41 HIV infection in volunteers HVTN and transgender DNA, 2009-13 receiving vaccine and 30 cases 505 women who have MRKAD5 in those receiving placebo. Pitisuttithum, et al. JID 2006 sex with men, US M Robertson, et al. Available at http://www.hvtn.org/science/step_buch.html Supachai Rerks-Ngarm, et al. N Engl J Med 2009 HVTN505: SOURCE: http://www.aidsmap.com/Researchers-stop-the-only-current-HIV-vaccine-efficacy-trial/page/2640732/ RV144: Prime - Boost strategy using two different vaccines:for inducing both humeral and cell mediated immunity Prime Vaccine: ALVAC-HIV (vCP1521) from Sanofi Pasteur • Recombinant canarypox virus expressing the product of HIV-1 env, gag and protease genes gp120 env from Thai subtype E (92TH023) gp41, gag, and protease from LAI (subtype B) Booster vaccine: AIDSVAX ® B/E from VaxGen Inc. • Recombinant gp120 from MN(subtype B)and A244 (subtype E) • 16,402 HIV-negative men and women were enrolled. • 13,978 participants had completed full series of vaccinations HIV test, risk assessment and counseling 0.5 1 2 3 (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 Challenges in site preparation • Require massive infrastructure strengthening, capacity building (8 clinical sites at the district level) • Personnel and staffing : training of various level of staffs on GCP, Protocol, SOP etc. (120 full time and 200 part time ) • Establishing Trial Registry and Repository Center at MOPH (>100,000 specimens were collected) • HIV ELISA with electronic reporting system with VALIDITY system at AFRIMS • Vaccine depository center (approx.109,000 vaccine vials delivered and kept in batches) • Data management with Data fax,validating system at Mahidol U.( millions pages of case report forms) Role of VTC staffs & CRC(s) • Enrollment • Vaccination • Reactogenicity, AE(s), SAE(s), documentation, reporting and follow up Clinical Team VTC MD Director-MOPH • SI • MD Supervisor - 5 • Nurse (6 - 10/site) • VTC CRC - 5 • CRC - CRC 5/site - Pharmacist 2/site Total 150 full time - RA 2/site staff and 200 part times Clinic Activities Inform consent process • Video presentation, • Group discussion • Individual discussion • Mini –exam T/F and need to get 80% marks before signing consent form RA Registry VDO informed consent Group informed consent Individual Informed Consent Vital Signs Urine Pregnancy Test (Only Female) Medical History and Blood Draw Eligibility Check VACCINE STORAGE VACCINE CODE PHARMACIST DOCUMENTATION &preparation Training CRC, RA, Pharmacist Screening all sites (N = 26,658) Male 15,973 (60%) Female 10,685 (40%) Enrollment all sites (N = 16,402) Male 10,068 (61%) Female 6,334 (39%) Participants with age under 20 yrs (N =2,540) Male 1,658 (65%) Female 882 (35%) 13,977 volunteers received all 4 vaccinations 90% follow up at three years Retention and clinical activities at the sites ( started from 2005) Extend Service Hours on Sunday 24-hour Mailing Edutainment and one evening phone and campaigns/ Provider clinic per week access phone interactive based games system reminders 16,402 90% volunteers interval Enrolled Retention Mobile Tracking Volunteer Cultural Quarterly unit activities Relation, activities exhibition activities (Home Club visit) activities with educational boards Provider based system: • The volunteers are entitled for receiving care and follow up continuously by the same staff. • This was aimed to establish closed relation between the volunteers and clinical staff and to increase volunteers’ satisfaction of services. • Volunteer satisfaction survey was conducted in 1,523 volunteers at clinical sites ( from 13/09/06 to 27/09/06). 1,141 volunteers (93%) expressed their satisfaction in provider based system.
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