Dr Shahin Gharakhanian presentation at the 3rd Annual Vaccine R&D Conference in Washington DC, 15 November 2017

Critical review of Therapeutic Vaccines for the Functional Cure of the HIV Infection: lessons learned within clinical development programs, 2011-2017.



Functional cure without eradication of HIV-1, implies effective host immunity to control HIV replication. This hypothesis is based on the strong immune responses observed in limited cohorts of untreated long-term non-progressor/elite controllers, or case reports about long-term virological remission following discontinuation of early-stage initiated antiretroviral therapy. The cure research agenda includes therapeutic vaccination, currently 11 trials are listed (Ref. TAG Pipeline Report, 2017). Based upon the systematic evaluation of two major programs conducted from 2011 to 2017, lessons can be drawn: (1) Non-alignment of corporate/clinical plans, (2) Need for data on mechanism of action, (3) Sub-optimal dose selection studies followed by uncontrolled initial clinical trials that lead to prolonged development times and accrued funding needs. Systematic review of past programs allows to optimize future planning.

General References:

1)    Sommerfelt M, Mørk A, Okvist M, Hjelmaas U, Gharakhanian S. Approaching HIV functional cure applying Vacc-4x, a peptide-based therapeutic HIV vaccine: clinical development methodological considerations. NIH Strategies for HIV Cure Meeting, NIH, Bethesda MD, 14-16 Nov. 2016, Abst.#68

2)    Vieillard V, Gharakhanian S, Lucar O, et al. Perspectives for immunotherapy: which applications might achieve an HIV functional cure? Oncotarget, 2016; 1-13.

3)    Katlama Ch., Rockstroh JK, Gatell JM, Tsong R, Girard PM, Slama L, Simon A, Launay O, Cotte L, Reynes J, Gharakhanian S. VAC-3S immunotherapeutic HIV vaccine combined with ART is immunogenic and safe. Phase II initial analysis of the IPROTECT1 multicenter European study. Towards HIV Cure Symposium 2015, 18-19 July, [PE66] & IAS, 20 July, Vancouver, Canada. [MOPEA038].


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