MVP Access Program Access to Data and Sera collected during the MenAfriVac clinical trials

Transcription

1 MVP Access Program Access to Data and Sera collected during the MenAfriVac clinical trials 23 February 2016 The MVP Closure Conference Lionel Martellet Clinical Opera0ons Manager

2 Presenta;on Overview 1. Aim of the MVP Access Program 2. Overview of MVP Data/Sera Collec0on 3. Loca0on and set-up of the Sera Bank 4. MVP Access Program Governance 5. Steps for Access to Sera and Data 6. Follow-up to delivery of samples/data 7. Link for further informa0on

3 MVP Access Program Aim Establish a mechanism to enable qualified inves;gators (in collabora0on with study sites) to access data/sera collected during the Meningi;s Vaccine Project and answer specific research ques0ons of public health interest (excluding gene0c research). A qualified inves;gator may be from the study site or may be from another ins0tu0on. However, each proposal submiqed must include at least one qualified inves0gator from each ins0tu0on from which data or sera are to be u0lized. 2

4 MVP Clinical Development Program PsA-TT-003a 2-10 year-olds, n=340 PsA-TT year-olds, n=830 Phase II/III India Phase II Ghana Phase III Mali Phase III India Phase II Mali PsA-TT-006, safety only 1-29 year-olds, n=6000 PsA-TT-004 Infants, n=1200 PsA-TT-007 Infants, n=1500 Phase II Mali The Gambia Phase II/III, Mali Senegal, The Gambia PsA-TT years, n=900 PsA-TT years, n=600 Persistence Pers , n=1223 PsA-TT-001 Adults, n= 74 WHO Submission WHO Pre- Qualifica;on Phase I India DCGI Submission DCGI Export License DCGI License for India Pediatric Indica;on Submission Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun

5 MVP Access Program Collec;on (Sera and Data) Study PsA-TT-002 Phase 2 PsA-TT-003 Phase 2/3 PsA-TT-004 Phase 2 PsA-TT-007 Phase 3 Pers Phase 4 Study objec;ves Safety, Immunogenicity, Immune Persistence (The Gambia, Mali) Safety, Immunogenicity, Immune Persistence, Carriage (The Gambia, Mali, Senegal) Dose Selec0on, Schedule Evalua0on, Immune Persistence (Ghana) Confirming Schedule, Expanding Safety (Mali) Persistence measure (The Gambia, Mali, Senegal) Age of enrolled subjects Number of subjects months year-olds weeks months year-olds of 9 Clinical Study files, Case Report Form data and Laboratory Results from four study sites in West Africa 4

6 MVP Sera Bank Collec;on Samples from all African studies ~74,000 vials Long term storage -80 o C Sample quan0ty varies by study Subjects contribu0ng serum range in ages 14 wks to 29 yrs. Storage was maintained at -20 o C (or lower) at sites during study conduct Serum sample quan00es can be confirmed prior to any shipment to ensure samples meet the needs of the inves0gator 5

7 MVP Sera Bank Collec;on Number of tubes (less than 500 µl each) 17,670 22,674 20,280 11, PsA-TT-002 PsA-TT-003 PsA-TT-004 PsA-TT-007 Pers-002 Pers-003 Mali, The Gambia Mali, The Gambia, Senegal Ghana Mali Mali, The Gambia Mali, The Gambia, Senegal n=600 n=900 n=1200 n=1500 n=509 n= yrs 2-30 yrs 14 wks-4 yrs 9 mos-19mos 6-7 yrs 6-36 yrs 7 0mepoints 4 0mepoints 8 0mepoints 4 0mepoints once once 7

8 MVP Sera Bank, University of Siena, Italy Four -80 o Celsius Freezers (3+1 back-up) under restricted access 24/7 temperature controlled facili0es Database system for tracking of inventories and shipments Coordina0on of shipments and monitoring of storage GCLP trained staff SOP system for QA Filing system for all Sera Bank records Accountability PATH and SIIL joint ownership of the sera PATH-SIIL contract UNISI for the Sera Bank opera0on 6

9 MVP Access Program Governance The governance of this program is established in a specific Memorandum of Understanding (MoU) signed by PATH, SIIL and each par0cipa0ng study site. The MoU defines Guiding Principles of the Program Roles and Responsibili0es of the different par0es Steps for access to either Sera or Data housed from the African studies 8 MoU has key suppor0ng appendices: ICFs from the MVP Clinical Studies Proposal template for sera/data request Material Transfer Agreement (MTA) Template Analyzed Data Transfer Agreement (ADTA) Template

10 Overview of steps for Sera access 1. Access website for preliminary informa;on hqp:// advancing-research.php hqp:// 6. If posi0ve decision is obtained then all required scien;fic/erc approvals at each QI s site must be submiqed along with the final approved protocol. 7. PATH will confirm these approved documents align with the original research proposal submiqed prior to execu0ng a material transfer agreement (MTA). 2. Request further informa;on on studies and process for submikng a research proposal from PATH through address: meningi0sresearch@path.org 3. Based on specific interest, PATH will inves;gate and confirm availability of samples in sera bank 9 5. PATH and SIIL joint review on first come first serve basis and share decision with QIs. 4. Qualified Inves;gator(s) (QI) submits a research proposal using the PATH template. At least one QI must be listed for each site where serum or data are being u0lized. 8. The MTA is signed by qualified inves0gators and PATH prior to samples or data being made available. 9. A shipment plan with EpidMol (UNISI) is established for the transfer of the samples. PATH may then authorize shipment 8. The research ;tle is posted externally on the PATH website

11 10 Overview of steps for Data Access Same steps for serum access The PATH Sta0s0cian is responsible for conduc0ng analysis and providing data output to the QIs Amer the ADTA is signed, an agreed upon 0meframe will be established between the QIs and the PATH Sta0s0cian for the release of the data Post-access follow-up of all Approved Proposals Repor0ng to PATH on research ac0vi0es based on planned 0melines Final traceability and accountability for all samples Publica0on plan completed with appropriate acknowledgement of MVP, Study Sites, PATH and SIIL.

12 MVP Access Program Info: hqp:// hqp://