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
Department Name: UNLISTED
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.
Organisations
- Imperial College London (Lead Research Organisation)
- Muhimbili University of Health and Allied Sciences (Collaboration)
- University College London (Collaboration)
- National Institute for Medical Research, Tanzania (Collaboration)
- Karolinska Institute (Collaboration)
- Medical Research Council of South Africa (MRC) (Collaboration)
- Lausanne University Hospital (CHUV) (Collaboration)
- Ludwig Maximilian University of Munich (LMU Munich) (Collaboration)
- Instituto Nacional de Saúde (Collaboration)
- MRC/UVRI Uganda Research Unit on AIDS (Collaboration)
- Africa Health Research Institute (Collaboration)
- Eurovacc Foundation (Collaboration)
People |
ORCID iD |
Publications
Kusemererwa S
(2021)
Predictors of oral pre-exposure prophylaxis (PrEP) uptake among individuals in a HIV vaccine preparedness cohort in Masaka, Uganda.
in Medicine
| Description | Additional funding for PrEPVacc |
| Amount | € 1,624,582 (EUR) |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 01/2022 |
| End | 12/2024 |
| 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 shortfall funding |
| Amount | € 1,000,000 (EUR) |
| Organisation | German Federal Ministry of Education and Research |
| Sector | Public |
| Country | Germany |
| Start | 01/2022 |
| End | 12/2022 |
| 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 | Getty photoshoot at the MRC/UVRI Masaka clinical site for the PrEPVacc trial |
| Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Media (as a channel to the public) |
| Results and Impact | Luke Dray,a photojournalist for Getty photo agency visited and documented PrEPVacc work at the Masaka site on 16 & 17 March. He photographed trial participants and clinical staff at the site His work can be seen in the Nature Article -Preparing society for an HIV vaccine-16th May 2022 |
| Year(s) Of Engagement Activity | 2022 |
| 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 |