7 June 2021
Third annual project meeting MTBVAC in new-borns Phase 2a
The consortium of ‘MTBVAC in newborns Phase 2a’ held its third annual project meeting virtually on 31 May to discuss project progress.
The meeting, led by the coordinator Biofabri, was attended by all partners including the Scientific and Clinical Advisory Team (SCAT). The SCAT and Biofabri presented the clinical development plan and next Phase 3 trial, and the newest insights of pre-clinical assays of MTBVAC and exploratory immunogenicity endpoints.
This Phase 2a study aims to evaluate safety, reactogenicity and immunogenicity of MTBVAC at three escalating dose levels, compared to BCG vaccine, in healthy, BCG naïve, HIV unexposed, South African newborns.
Despite of the Covid-19 pandemic effects, two years after the first vaccination, the last vaccination was given in March 2021. In total 99 healthy, newborns are enrolled and followed for 12 months, therefore, a final analysis can be made in April 2022.
To move straight from the Phase IIa to Phase III study (RIA2019S-2652), a DSMB review in a blinded manner to determine and assess the most relevant immunogenic and safe MTBVAC dose will take place at D182 of the last vaccination, therefore, September 2021
The design of the proposed Phase III incorporates three case-driven assessments for futility and efficacy. Such a pathway would allow for earlier availability of the neonatal vaccine. Such a saving in time would have a major public health benefit when considering that the BCG vaccine has been reported to have variable protective effect.
18 March 2021
MTBVAC in new-borns Phase 2a trial completed its enrolment
Two years after the first new-born baby for the MTBVAC Phase 2a trial was enrolled, the enrolment of the study has completed. Early March the last baby in the trial received a vaccination.
The South African Tuberculosis Vaccine Initiative (SATVI) conducted the study in the Western Cape of South Africa, recruiting women in the third trimester of pregnancy, following them through delivery before enrolling their newborns. Babies are followed up over a period of 12 months. In total 99 healthy, BCG naïve, HIV unexposed newborns are enrolled into this study.
The completing of the enrolment is specially celebrated due to a challenging 2020 with unexpected and unavoidable major issues, namely the COVID-19 pandemic and lockdown in South Africa.
The restrictions imposed by the COVID-19 lockdown in South Africa impacted the duration of the study. These lockdown measures were implemented, firstly, to prevent rapid spread of infection and, secondly, to assist government in preparing for a potential increase in COVID-19 admissions to hospitals causing strain on the South African health care system. Therefore, measures resulted in closure of all sectors whilst only allowing essential services to proceed until beginning October 2020.
Fortunately, the study activities resumed from October 2020, which resulted in the completion of the enrollment early March.
This trial is funded and supported by the European and Developing Countries Clinical Trials Partnership (EDCTP).
A Phase 3 efficacy study is planned to start for early 2022. This will be an important step with the planned MTBVAC vaccination of nearly 7 000 infants.
This large, phase 3 clinical trial is partially funded and supported by EDCTP.
30 May 2020
Virtual project meeting ‘MTBVAC in newborns’
Originally the intention was to have a site visit at IPM in Madagascar this year. Due to the Covid-19 pandemic, a site visit was not possible so the project meeting was held virtually on May 28. All partners of the project attended including the members of the SCAT (the Scientific and Clinical Advisory Team).
Each partner presented an update about the progress and the SCAT presented the next steps in the clinical development plan. Also, the impact of the Covid-19 pandemic on the project was discussed and it became clear that this will cause some uncertainties in the project. Despite this uncertainty, progress has been made and some work packages have almost completed.
Depending on how the Covid-19 pandemic develops, the site visit to IPM in Madagascar is postponed to next year.
9 March 2020
Partners ‘MTBVAC in newborns’ participate in TBVI meeting and a joint meeting from EDCTP funded TB-projects
All partners of the project attended the TBVI meeting “Accelerating the TB vaccine pipeline – towards Horizon Europe” from 27-29 January 2020. This meeting brought together 120 scientists and policy makers from 70 research institutes, universities, industry, funding agencies, technical agencies from 21 countries.
In parallel to this meeting a joint meeting was organised with EDCTP funded TB-projects. EDCTP is funding three TB vaccine clinical trial projects knowing POR TB (coordinated by Statens Serum Institute, Denmark), priMe (coordinated by Vakzine Projekt Management GmbH, Germany) and MTBVAC in newborns (coordinated by BioFabri, Spain).
To enhance the collaboration between the projects and to maximise the impact, TBVI, commissioned by EDCTP, will develop tools that may support these joint project activities and help future TB vaccine clinical trial projects. This meeting in Les Diablerets was a kick off and meant to explain the purpose of the tools and the joint activities that will be developed.
EPLS as well as IPM presented their clinical sites during this meeting:
18 October 2019
Prof Dr Carlos Martin meets with the Pope
During the General Audience, Carlos Martín met the pope to tell him that after 30 years of research, an effective vaccine against tuberculosis may have been found. Please take a look at the video made by RomeReports.
25 July 2019
Annual meeting MTBVAC in newborns 3-4 July in Saint Louis, Senegal
The second annual project meeting of the Clinical Phase 2a study of MTBVAC vaccine in newborns took place at 3 and 4 July in Senegal. The Senegalese partner CRB-EPLS hosted the meeting and organised a visit to their sites in Saint Louis.
The project partners from Biofabri (Spain), Unizar (Spain), Satvi (South Africa), IPM (Madagascar), TBVI (the Netherlands) and of course CRB-EPLS from Senegal presented the progress of the several work packages and had a discussion about the progression of the project in general. The project implementation proceeds according to the original plan. The Steering Committee (SC) and the Scientific and Clinical Advisory Team (SCAT) had a separate meeting to discuss progress and next steps to be taken. Michelle Helinski as EDCTP observer attended the SC & SCAT meeting via TC.
Besides carrying out the Phase 2a dose-defining safety and immunogenicity study, the project also includes capacity building. This supports the vaccine efficacy trials in Tuberculosis-endemic regions of Sub-Saharan Africa. The project is part of the EDCTP2 programme supported by the European Union.
Dr Ingrid Murillo, coordinator of the project, says “This first annual project meeting brought together again all the partners one year after the Kick off Meeting in South Africa. The clinical trial Phase 2a together with the different work packages were reviewed and so many fruitful discussions took place. Projection of the study and next actions and steps were defined moving forward to the next study milestones. Dr. Gilles Riveau and his team demonstrated an excellent hospitality and the meeting organization was brilliant.”
25 March 2019
World TB Day: EDCTP investments in TB research rise to EUR 127 million
In 2018, three major grants were committed to support the development of several candidate TB vaccines: a total of EUR 31.5 million for three large clinical trials. Currently, these clinical trials conducted by 28 research institutions from sub-Saharan Africa, Europe and India, are well underway. The projects are PORTB, priME and MTBVAC in newborns. Please read the article on the EDCTP website.
18 February 2019
First enrolment into MTBVAC 202 – a Phase 2a trial in newborns
Today the first newborn baby for the MTBVAC 202 Phase 2a trial of a novel TB vaccine was enrolled onto the study and received her study vaccination. This trial is being conducted in the Western Cape, South Africa by the South African Tuberculosis Vaccine Initiative (SATVI), University of Cape Town.
In total 99 healthy, BCG naïve, HIV unexposed newborns will be enrolled onto the study in the coming months and carefully followed up over a 12 month period.
According to the project coordinator Dr Ingrid Murillo this study marks an important step forward in the development of MTBVAC. This trial, funded and supported by European and Developing Countries Clinical Trials Partnership (EDCTP) will build the bridge to the efficacy trial, the next MTBVAC challenge.
14 February 2019
Publication “Vaccination against tuberculosis”
The article ‘Vaccination against tuberculosis’ written by C Martin, N Aguilo and J Gonzalo-Asensio Enferm has been published: Infecc Microbiol Clin. 2018 Dec;36(10):648-656. Doi 10.1016/j.eimc.2018.02.006.
14 December 2018
“Dose-Defining Safety and Immunogenicity Study of MTBVAC in South African Neonates”
For information about the clinical trial, please follow the link “Dose-Defining Safety and Immunogenicity Study of MTBVAC in South African Neonates” (ClinicalTrials.gov: NCT03536117).
25 September 2018
Joint symposium at the EDCTP Forum 19 September 2018: ‘TB vaccine development: the results of unique collaborative effort’
At the EDCTP Forum that was held from 17-21 September 2018 in Lisbon, four EDCTP projects on TB vaccine clinical development presented their vaccine candidate during a symposium ‘TB vaccine development: the results of unique collaborative effort’.
The symposium provided an overview of recent progress in the development of TB vaccines and the results from collaborative efforts. It also highlighted the crucial role that EDCTP is playing in the clinical development of TB vaccine candidates.
The introductory presentation covered the current state of the TB vaccine pipeline and described a stage gating approach developed by Aeras and TBVI. The developed webtool ‘TB Vaccine Development Pathway’ for the TB vaccine community supports the development of novel vaccine candidates. This presentation was followed by a series of presentations on four large TB vaccine clinical trials recently funded by EDCTP. 28 Research institutions from sub-Saharan Africa, Europe and India will work closely together on these trials. These trials will evaluate the three different vaccine candidates (H56:IC31, VPM1002 and MTBVAC) and represent the largest European investment into clinical development of TB vaccines to date. Finally Aeras presented a collaborative approach to community engagement.
On 6-7 June the kick off meeting of MTBVAC in Newborns took place in Cape Town, South Africa. This project contains a Phase 2a dose-defining safety and immunogenicity study is being carried out. The project includes also capacity building to support vaccine efficacy trials in Tuberculosis-endemic regions of Sub-Saharan Africa. The project is part of the EDCTP2 programme supported by the European Union.
Project partners from South Africa (Satvi, UCT), Senegal (CRB-EPLS), Madagascar (IPM), Spain (Biofabri and Unizar) and the Netherlands (TBVI) attended the meeting. Also a representative of EDCTP, Tom Nyirenda, joined the kick off of this project. Furthermore, the Steering Committee held their first face-to-face meeting.
Work package leaders and members had the opportunity to be introduced to each other and to discuss about the study approach. The South African partner Satvi hosted also a visit to their field site. The meeting turned out to be a wonderful and promising start of the project.