ADVANCE-VAC4PM organisational structure includes three types of consortium bodies: strategic, implementation and advisory bodies:
Strategic Bodies: Project Steering Committee, and Trial Management/Steering Group (WP3).
Implementation bodies: Coordinator and Project Management Team, Work Package Leaders.
Advisory Bodies: Scientific and Ethics Advisory Committee, and Data and Safety Monitoring Board.
ADVANCE-VAC4PM project is organised in nine complementary Work Packages, each led by a Work Package Leader.
WP1: Preclinical optimisation and post-clinical assessment of the vaccine-induced immune response – Led by Inserm. The main objectives of this work package are: • Antigen preparation and preclinical immunology assessment to support the start of the clinical activities • Evaluation of VAR2CSA-specific immune responses in a cohort of pregnant Ghanaian women • Immunological assessment of clinical samples (from WP3) • Establishment of direct antibody epitope mapping techniques to inform future clinical development
WP2: GMP Manufacturing of vaccine candidates – Led by AdaptVac. The main objectives of this work package are: • GMP Manufacturing and stability assessment of both PRIMVAC and PAMVAC-cVLP clinical lots, • Safety-toxicity evaluation of PAMVAC- cVLP and of its co-administration with PRIMVAC/GLA-SE
WP3: Clinical testing of vaccines against PM – Led by Radboudumc. The main objectives of this work package are: • Phase 1 first-in-human clinical trial to assess safety, tolerability and immunogenicity of PAMVAC-cVLP and co-administration with PRIMVAC/GLA-SE in malaria-naïve adults • Adaptive phase I/II bridging trial to assess safety, tolerability and immunogenicity of PAMVAC-cVLP, PRIMVAC/GLA-SE, and/or their co-administration, vs control vaccine in lifelong malaria-exposed nulliparous adult and subsequently adolescent women.
WP4: Creation of pregnancy registers and evaluation of pregnancy mobile applications as a potential tool for monitoring pregnancy outcomes in PM vaccine trials. – Led by KHRC. The main objectives of this work package are: • To develop pregnancy registers as base to study interventions in pregnant women • To map existing open access pregnancy mobile applications as tools for monitoring pregnancy outcomes in PM vaccine trials • To evaluate the feasibility and acceptability of open-source mobile applications as a tool for tracking pregnancy outcomes among pregnant women in sub-Saharan Africa
WP5: Modelling Cost-effectiveness, Acceptability and Feasibility of vaccines against PM – Led by MUST. The main objectives of this work package are: • To model the cost effectiveness of PM vaccines compared with current standard of care (chemoprophylaxis with IPTp-SP and use of insecticide-treated nets) for prevention of perinatal mortality from provider and household perspectives. • To evaluate acceptability and feasibility of PM vaccines: - To explore opinions, identify experiences, and describe perspectives on the acceptability and feasibility of PM vaccines for the prevention of malaria associated adverse pregnancy outcomes. - To describe the opinions of health administrators, health providers, donors, and policymakers on the feasibility of vaccine roll-out. - To understand the barriers and facilitators to roll out and upscaling the PM vaccines.
WP6: Capacity Building – Led by GRAS. The main objectives of this work package are: • To strengthen the infrastructure of the centers that will conduct the clinical trials in Africa • To develop clinical immunology capacity for assessment of immune responses to PM vaccines • To train the next generation of recognized research leaders in clinical trial research and related activities
WP7: Communication, Dissemination, Exploitation and Stakeholder engagement – Led by FORS. A series of strategically planned and coherent activities will be implemented surrounding communication, dissemination, and exploitation of the project results, with the goal to maximize the impact of ADVANCE-VAC4PM. The specific objectives are to: • Prepare a detailed plan for dissemination, exploitation, and communication •Communicate the overall project and increase its visibility • Ensure appropriate, effective dissemination and exploitation the project results and achievements.
WP8: Project Management & Coordination – Led by EVI. The main objective of this work package is to set up an effective management framework to ensure that the overall combined project progresses towards its planned objectives in line with contractual commitments. The specific objectives are to: • Establish an efficient management infrastructure including all governance bodies, management procedures and tools • Conduct overall coordination and project management of the consortium • Implement day-to-day operational management of the overall project
WP9: Ethics Requirements – Led by EVI. The main objectives of this work package are: • Ensure observance of the required ethical standards. • Provide all relevant information related to animal experimentation and human clinical trials to the EC and the Independent Ethics Advisor