PrEPVacc - EuroVacc

A combination efficacy study in Africa of two DNA-MVA- or DNA- Env protein HIV-1 vaccine regimens with pre-exposure prophylaxis (PrEPVacc) is a project supported by European and Developing Countries Clinical Trials Partnership (EDCTP). It is an African-led European-supported HIV prevention phase IIB study running in East and Southern Africa. For the first time, it is combining evaluation of experimental HIV vaccines and pre-exposure prophylaxis (PrEP) at the same time. PrEPVacc will compare DNA-MVA-protein with DNA-protein immunisation; and explore universal PrEP in an HIV vaccine study population. Its adaptive trial design is novel in the HIV vaccine field and will generate data on HIV vaccine efficacy and investigate correlates of protection, address adherence and attitudes to PrEP and its impact on HIV vaccine trial.

PrEPVacc is coordinated by Imperial College London, UK. EVF provides one of the experimental vaccine candidates (DNA-HIV-PT123 vaccine) under evaluation in the trial.

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Protocol. Nr.	Description	Sponsor(s)	Trials Sites	Status	Results
PV1 (PrEPVac)	A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis (PrEPVacc)	Imperial College London	Uganda, Tanzania, South Africa, Mozambique	Started NCT04066881	Ongoing
HVTN111	A phase 1 clinical trial to evaluate the safety and immunogenicity of HIV clade C DNA and of MF59-adjuvanted clade C Env protein, in healthy, HIVuninfected adult participants	DAIDS, NIH	South Africa, Tanzania, Zambia	Completed NCT02997969	Hosseinipour 2020
HVTN108	A phase 1/2a clinical trial to evaluate the safety and immunogenicity of HIV clade C DNA, and of MF59®- or AS01B-adjuvanted clade C Env protein in various combinations, in healthy, HIV-uninfected adult participants	DAIDS, NIH	US, South Africa	Completed NCT02915016	Manuscript in preparation
HVTN105	A phase 1b clinical trial to evaluate the safety and immunogenicity of different combinations of DNA-HIV-PT123 and AIDSVAX® B/E in healthy, HIV uninfected adult participants	DAIDS, NIH	US	Completed NCT02207920	Rouphael 2019
EV07	An open label phase I clinical trial to evaluate the effect of late boost on HIV-uninfected vaccinees from EV06 trial	EVF	Uganda	Completed NCT03391375	Manuscript in preparation
EV06	A phase I double blind placebo-controlled clinical trial to evaluate the safety and immunogenicity of the combination of DNA-HIV-PT123 and AIDSVAX®B/E in HIV-1-uninfected adult participants with or without underlying Schistosoma mansoni infection	EVF	Uganda	Completed NCT02516306	Manuscript in preparation
HVTN096/ EV04	A phase I double blind placebo-controlled clinical trial to evaluate the safety and to compare the priming ability of NYVAC alone versus NYVAC + AIDSVAX® B/E, and DNA alone versus DNA + AIDSVAX® B/E when followed by NYVAC + AIDSVAX® B/E boosts in healthy, HIV-1-uninfected adult participants	DAIDS/ EVF	Switzerland	Completed NCT01799954	Pantaleo 2019
HVTN092	A phase I clinical trial to evaluate safety and to compare the immunogenicity of 3 DNA vaccine Prime schedules followed by a NYVAC vaccine boost in healthy, HIV-1 uninfected adult participants	DAIDS	Switzerland, US	Discontinued NCT01783977
HVTN078	A phase Ib clinical trial to evaluate the safety and immunogenicity of heterologous prime/boost vaccine regimens (NYVAC-B/rAd5 vs. rAd5/NYVAC-B) in healthy, HIV-1 uninfected, Ad5 seronegative adult participants	DAIDS / EVF	Switzerland	Completed NCT00961883	Bart 2014
EV03/ ANRSVAC20	Phase II Immunogenicity and safety of 3 DNA-C prime followed by 1 NYVAC-C boost versus 2 DNA-C prime followed by 2 NYVAC-C boost	EVF/ ANRS	Switzerland, UK, Germany, France	Completed NCT00490074	Levy 2020
EV02	Phase I Safety and Immunogenicity comparing DNA-C prime and NYVAC-C boost versus NYVAC-C alone	EVF	Switzerland, UK	Completed	Harari 2008 McGormack 2008 EV02 press release
EV01	Phase I Safety and Immunogenicity Study of NYVAC-C alone	Imperial College London	Switzerland, UK	Completed	EV01 Result Press release Bart 2008

Protocol. Nr.	Description	Sponsor(s)	Trials Sites	Status	Results
TheraVac01	Phase I NYVAC immunization induces polyfunctional HIV-specific T-cell responses in chronically-infected ART-treated HIV patients	EVF	Switzerland	Completed	Harari 2012
TheraVac02	Phase I safety of MVA-B in chronic HIV-1 infected patients successfully treated with HAART	EVF	The Netherlands	Completed	Vermeulen 2008 Abstract