EDCTP Third Forum PARTNERSHIP AND AFRICAN LEADERSHIP IN VACCINE RESEARCH AND HIV/AIDS DRUG. MBOUP Souleymane
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1 EDCTP Third Forum PARTNERSHIP AND AFRICAN LEADERSHIP IN VACCINE RESEARCH AND HIV/AIDS DRUG MBOUP Souleymane
2 HIV VACCINE IN AFRICA In 2005, 13 new trials of preventive AIDS vaccine candidates began in 9 countries around the world. Two of these involved vaccine candidates that entered Phase II trials, an intermediate stage of clinical evaluation. Several of those newly initiated trials involved novel vaccination strategies Participation by Africa in those trials is continuously increasing with Rwanda started its first AIDS vaccine and South Africa began the country s first Phase II AIDS vaccine trial
3 PROGRESS IN NUMBER OF COUNTRIES PARTICIPATING IN VACCINE TRIALS country 8 countries participating in vaccine trials
4 CLINICAL TRIAL SITES IN AFRICA PARTICIPATING IN HIV VACCINE TRIALS Kampala, Uganda Kayunga, Uganda Mulago, Uganda Entebbe, Uganda Masaka, Uganda Kigali, Rwanda Lusaka, Zambia Gabarone, Botswana Kericho, Kenya Kilifi, Kenya Kisumu, Kenya Nairobi, Kenya Dar es Salaam, Tanzania Blantyre, Malawi Medunsa,SA Mbeya, Tanzania Soweto, SA Cape Town, SA KOSH,SA Durban, SA Active Pending
5 PROGRESS IN NUMBER OF COUNTRIES PARTICIPATING IN VACCINE TRIALS Countries currently involved in vaccine trials Countries preparing for vaccine trials
6 COMPLETED TRIALS IN AFRICA* Phase Trial Name/ Sponsor Country ALVAC205 (Pasteur Merieux): Gag, pol, env (Subtype B) Status Phase I (40) DAIDS Uganda Complete DNA Plasmid (Polyepitope Pharmexa Epimmune): Polyepitope Phase I (42) HVTN/DAIDS Botswana Complete DNA MVA (Oxford / IAVI): Gag, polyepitope (Subtypes A) Phase II (238) IAVI Kenya, Uganda, South Africa Complete VEE Replicon (AlphaVax): Gag (Subtype C) Phase I (88) HVTN/DAIDS South Africa, Botswana Complete Ad 5 (Merck): Gag (Subtype B) Phase II (120) HVTN/DAIDS South Africa, Malawi Complete *follow-up still ongoing
7 Phase PREVENTIVE VACCINE CONCEPTS IN TRIAL IN AFRICA Trial Name/ Sponsor Country Status Adeno Associated (TG, IAVI): Gag-Pr-RT (Subtype C) Phase II (90) IAVI Uganda, Zambia, South Africa Enrolling DNA prime/ Ad5 boost (VRC): Gag, Pol, Nef, Env (Subtypes A,B,C) Phase II (114) IAVI V001, VRC/DAIDS Rwanda, Kenya Enrolling Phase II (240) HVTN 204, VRC/ DAIDS South Africa Enrolling Phase II (324) RV172,WRAIR VRC/DAIDS Uganda, Kenya, Tanzania Enrolling
8 Phase PREVENTIVE VACCINE CONCEPTS IN TRIAL IN AFRICA Trial Name/ Sponsor Ad5 (Merck): Gag-Pol-Nef (Subtype B) Country Status IIb (3000) HVTN503, Merck/DAIDS South Africa Pending DNA, MVA: Gag, RT, env, pol (Subtype A, E) II (60) SIIDC, Karolinska, EU,Sida/SARE C Tanzania Pending ALVAC-HIV vcp1521: Gag, Pro, Env (Subtype B, E) I (50) Perinatal HPTN027/ DAIDS Uganda Pending
9 FIRST TEST OF CONCEPT TRIAL IN AFRICA (Q4 2006): MRKAd5 Trivalent Vaccine ITR L ψ hcmv gag pa MRKAd5 HIV-1 gag ITR R ITR L ψ hcmv pol pa MRKAd5 HIV-1 pol ITR R ITR L ψ hcmv nef pa MRKAd5 HIV-1 nef ITR R ΔE1 1:1:1 mixing of 3 vectors G. Gray, PHRU, SA
10 FIRST TEST OF CONCEPT TRIAL : HVTN 503 A South African Study to test subtype B vaccine (Ad5 gag, pol, nef) in subtype C region (similar to STEP HVTN502 in MSM in USA): Will subtype B vaccine be efficacious against subtype C heterosexual infection Markedly enhance the information on efficacy in women Refine the assessment of the impact of pre-existing Ad5 titers More than double the number of endpoints to enhance the evaluation of correlates of protection. Adapted from G. Gray, PHRU, Soweto
11 VRC DNA PRIME RAD5 BOOST Currently largest trial concept being tested in Africa Enrolling into 3 trials /6 countries in Africa >600 participants Involving 3 major vaccine initiatives /networks. HIV Vaccine Trials Network (HVTN) US Military HIV Research Program (USMHRP) International AIDS Vaccine Initiative (IAVI) PAVE 100 (in planning fo 2007/8) will be next proof of concept trial in Africa planning to enrol ~12,000 globally and ~8,000 in Africa
12 THERAPEUTIC VACCINE CONCEPTS IN TRIAL IN AFRICA Phase Sponsor Country Status DNA Plasmid: Tat, rev, nef, gag, pol, env (Subtype B) Phase II (60) FIT Biotech South Africa Enrolling Tat Protein: (Subtypes B) Phase II (60) AVIP /ISS South Africa Enrolling E. Vardus, PHRU, SA
13 PLANNED VACCINE TRIALS PAVE 100: DNA /Ad5; ~ participants; in Africa; multiple sites; multiple partners. Mrk Ad5: Adolescent trial in SA (HVTN/DAIDS) SAAVI DNA /MVA: Phase I trial in SA (SAAVI / HVTN /DAIDS) EuroVac (NYVAC) Chiron (Subtype C Env) Tat Vaccine (AVIP /ISS)
14 INCREASING PARTICIPATION BY AFRICA > volunteers? 12 countries 50 volunteers 1 country 400 volunteers 8 countries 15 trial sites 2010 > volunteers
15 SCIENTIFIC CHALLENGES SPECIFIC TO AFRICA Vaccine Pipeline is too narrow Pre-existing immunity to vaccine vector Genetic Diversity
16 Osmanov, pers. comm
17 «ARV therapy in sub saharan Africa : -Complicated combination regimens -Expensive and dangerous -Severe side effects -Rapid development of drug resistance in the community». Instead of promoting expensive and dangerous ARV therapies PREVENTION» Lancet,1998
18 SHORT TERM EVALUATION ON THE FIRST 175 PATIENTS Virological and immunological results similar to Western countries Excellent Adherence Good Accessibilty and Acceptability
19 CLINICAL TRIALS IN AFRICA Access to ARV for HIV-infected individuals in resource-poor settings Efficacy? Safety? Adherence? Potent, safe, inexpensive simplified regimen
20 Once a day DDI/3TC/EFV regimen in treatment naive HIV-1 1 infected adults in Senegal ANRS / IMEA 011 study (1999) R.LANDMAN 1, R.SCHIEMANN 1, S.THIAM 2, A.CANESTRI 1, M.VRAY 4, C.DALBAN 4 E. DELAPORTE 3, S. MBOUP 2, PS. SOW 2, MA. FAYE NIANG 2,PM. GUEYE 2, G. PIEL 4, G. PEYTAVIN 1, S. BADIANE 2, PM. GIRARD 1, JP. COULAUD 1, I. NDOYE 2, AIDS 2003
21 Once a day HAART regimen in treatment naive HIV-1 infected adults in Senegal ANRS / IMEA 011 study Evolution from baseline of viral load and CD4 count Δ VL log10 copies/ml months 6 months 12 months 15 months Δ CD4 cells/mm ,2-3,5-3,5-3,
22 HIV and non HIV pathologies / IMEA 011 % Path VIH % Path non VIH J0 S2 M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12
23 CLINICAL TRIALS in Africa 1. First trial in Africa of a simplified regimen 2. effective through treatment period among severely immunocompromised individuals in resource-poor settings 3. ARV clinical trial in resource-poor settings feasible 4. Introduction et validation of new ARV Drug in SENEGAL
24 ONGOING TRIAL ANRS 1207/IMEA 025: Once a day Tenofovir/Emtricitabine/Efavirenz regimen (3 pills)
25 Viral load ANRS 1207/IMEA ,8-3,6-3,6 JO (N=40) M1 (N=39) M3 (N=37) M6 (N=32) Série1 0-2,8-3,6-3,6
26 Preliminary results : ANRS 1207/IMEA 025 Good virological and immunological efficacy Good adherence to treatment More simplified regimen 2 daily pills Truvada (TDF/FTC)+EFV 1 daily pill TDF/FTC/EFV)
27 ATRIPLA : TDF+FTC+EFV 1 daily pill TRUVADA + SUSTIVA = ATRIPLA Mathias A., IAC 2006, Abs. TUPE0098
28 Research Clinical Center, Fann
29 HIV LABORATORIES AT LE DANTEC
30 HIV LABORATORIES AT LE DANTEC
31 CONCLUSION (1) Increased African participation in vaccine trials Increased funding to address scientific questions Increased partnerships to accelerate the field Increased success rate at an accelerated pace (Results of first IIb trials in Africa still 3-5 years)
32 CONCLUSION (2) ARV scaling up in developing countries Host, viral,environmental factors ( logistical, operational etc..) Affordable second line regimen required Need of incresing African participation in ARV clinical trials Impact in developing and developed countries
33 ACKNOWLEDGEMENTS WILLIAMSON C DELAPORTE E SOW SALIF
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