IDEA Program - EuroVacc

Dissecting the Immunological Interplay between Poverty Related Diseases and Helminth Infections: An African-European Research Initiative (IDEA) is a project funded by the European Union FP7 program with more than 20 institutes from Europe and Sub-Sahara Africa. IDEA focuses its efforts on four primary objectives: a) the worm-induced modulation of the functional and molecular profile of HIV-, TB- and malaria-specific immune responses, b) the impact by worm co-infections on measures of disease activity of PRDs, c) the immunologic markers of worm-, HIV-, TB- and malaria-specific immune responses associated with better control of pathogen replication and disease, and d) the modulation by worm co-infections of vaccine-induced immune responses.

IDEA is coordinated by the Lausanne University Hospital (CHUV). EVF has provided the support in project management and has sponsored the HIV vaccine trials (EV06 and EV07).

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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