A combination efficacy study in Africa of two DNA-MVA- or DNA- Env protein HIV-1 vaccine regimens with pre-exposure prophylaxis (PrEP) – supplementary funding for MPLA-Liposomes

Lead Research Organisation: Imperial College London

Abstract

Abstracts are not currently available in GtR for all funded research. This is normally because the abstract was not required at the time of proposal submission, but may be because it included sensitive information such as personal details.

Technical Summary

Supplementary funding for the acquisition of MPLA-Liposomes for the ongoing PrEPVacc study a Phase IIb, three-arm, two-stage HIV efficacy vaccine trial with a second randomisation to compare the newer PrEP drug Descovy to the established standard for PrEP, Truvada.

Publications

10 25 50
 
Description PrEPVacc Supplementary funding
Amount $649,308 (USD)
Organisation Gilead Sciences, Inc. 
Sector Private
Country United States
Start 01/2020 
End 12/2024
 
Description PrEPVacc consortium 
Organisation Africa Health Research Institute
Country South Africa 
Sector Charity/Non Profit 
PI Contribution Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study.
Collaborator Contribution UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management
Impact The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet.
Start Year 2018
 
Description PrEPVacc consortium 
Organisation Eurovacc Foundation
Country Switzerland 
Sector Charity/Non Profit 
PI Contribution Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study.
Collaborator Contribution UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management
Impact The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet.
Start Year 2018
 
Description PrEPVacc consortium 
Organisation Instituto Nacional de Saúde
Country Mozambique 
Sector Public 
PI Contribution Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study.
Collaborator Contribution UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management
Impact The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet.
Start Year 2018
 
Description PrEPVacc consortium 
Organisation Karolinska Institute
Country Sweden 
Sector Academic/University 
PI Contribution Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study.
Collaborator Contribution UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management
Impact The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet.
Start Year 2018
 
Description PrEPVacc consortium 
Organisation Lausanne University Hospital (CHUV)
Country Switzerland 
Sector Hospitals 
PI Contribution Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study.
Collaborator Contribution UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management
Impact The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet.
Start Year 2018
 
Description PrEPVacc consortium 
Organisation Ludwig Maximilian University of Munich (LMU Munich)
Country Germany 
Sector Academic/University 
PI Contribution Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study.
Collaborator Contribution UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management
Impact The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet.
Start Year 2018
 
Description PrEPVacc consortium 
Organisation MRC/UVRI Uganda Research Unit on AIDS
Country Uganda 
Sector Public 
PI Contribution Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study.
Collaborator Contribution UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management
Impact The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet.
Start Year 2018
 
Description PrEPVacc consortium 
Organisation Medical Research Council of South Africa (MRC)
Country South Africa 
Sector Public 
PI Contribution Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study.
Collaborator Contribution UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management
Impact The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet.
Start Year 2018
 
Description PrEPVacc consortium 
Organisation Muhimbili University of Health and Allied Sciences
Country Tanzania, United Republic of 
Sector Academic/University 
PI Contribution Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study.
Collaborator Contribution UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management
Impact The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet.
Start Year 2018
 
Description PrEPVacc consortium 
Organisation National Institute for Medical Research, Tanzania
Department NIMR Mbeya Research Centre
Country Tanzania, United Republic of 
Sector Academic/University 
PI Contribution Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study.
Collaborator Contribution UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management
Impact The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet.
Start Year 2018
 
Description PrEPVacc consortium 
Organisation University College London
Department Medical Research Council Clinical Trials Unit (MRC CTU) at UCL
Country United Kingdom 
Sector Public 
PI Contribution Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study.
Collaborator Contribution UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management
Impact The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet.
Start Year 2018
 
Title PrEPVacc clinical trial 
Description PrEPVacc is an international, multicentre, double-blind vaccine study will be a three-arm prospective 1:1:1 randomisation comparing each of two experimental combination vaccine regimens with placebo control. The study is funded by EDCTP. Pre-screening for risk and HIV status will take place as part of a Registration Cohort which will precede and continue in parallel to PrEPVacc enrolments. This will give HIV negative volunteers time to learn about the PrEPVacc trial and facilitate timely enrolment. Clinical screening for the vaccine trial will take place during the 8 weeks prior to randomisation. Eligible participants will be enrolled at week 0 and randomised to one of three vaccine arms: ? DNA-HIV-PT123 and AIDSVAX® B/E (target wks 0,4,24,48) ? DNA-HIV-PT123 and CN54gp140+MPLA-L (target wks 0,4), then MVA-CMDR and CN54gp140+MPLA-L (target wks 24,48) ? Saline placebo (target wks 0,4,24,48 There will be a concurrent 1:1 randomisation comparing two PrEP regimens, open-label: ? Daily TDF/FTC ? Daily TAF/FTC Participants will continue to receive study PrEP through to 2 weeks after their third immunisation after which access to PrEP will revert to locally registered supply of generic drug. The trial is currently enrolling at 4 clinical centres, 2 in Tanzania, 1 in South Africa and 1 in Uganda. To date the trial has enrolled 543 out of 1668 participants 
Type Preventative Intervention - Physical/Biological risk modification
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2017
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Trial is still recruiting and there are no notable impacts so far. 
 
Description Article in Science et Vie 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Professor Jonathan Weber discusses the PrEPVacc trial in an Article in Science et Vie (French Magazine)-After 40 years of failure for a vaccine against HIV, How COVID has renewed hope'
https://www.science-et-vie.com/corps-et-sante/7-vaccins-prometteurs-dans-les-laboratoires-65320
Year(s) Of Engagement Activity 2021
 
Description Key note address 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Professor Jonathan Weber gave a presentation of the PrEPVacc study for the Pride in Stem day which is an International Day of LGBTQIA+ People in STEM.
Year(s) Of Engagement Activity 2021