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PA00XCSB.Pdf Leidos Proprietary 1. EXECUTIVE SUMMARY A summary of efforts for the planned, ongoing, and completed projects for the Malaria Vaccine Development Program (MVDP) contract for this reporting period are herein detailed. A compiled Gantt chart including activities associated with each of the projects has been created and included as an attachment to this report. Ongoing projects that will continue through FY2019 include two vaccine development projects, the CSP vaccine development project (CSP Vaccine) and liver stage vaccine development project (Liver Stage Vaccine), as well as the clinical study with RH5 (RH5.1 Clinical Study), the latter to assess long-term immunogenicity in RH5.1/AS01 vaccinees. Of note is that while both the CSP and the liver stage vaccine development projects were initiated as epitope-based projects, these have since been realigned to target whole proteins; therefore, the project names have also been realigned to remove “epitope-based.” Expansion of work on the RCR complex into a vaccine development project (RCR Complex) occurred in early FY2019 and this project will continue until the end date of the contract. Lastly, a new project, the RH5.1 human monoclonal antibody identification and development project (RH5.1 Human mAb), was initiated in early FY2019 and will continue until the end date of the contract. Two projects were completed in FY2019, the blood stage epitope-based vaccine development project and the PD1 blockade inhibitor project (PD1 Block Inh). Leidos continues to seek collaborators for information exchange under NDA, reagent exchange under MTA, and collaboration under CRADA, to expand our body of knowledge and access to reagents with minimal cost to the program. This type of collaboration benefits the malaria research community and extends the utility of the contract. The information contained herein is intended to provide technical detail regarding activities conducted within the specified reporting period; however, at the request of USAID, Leidos retains data in quarterly reports for activities completed within the relevant fiscal year. Of note is that GO (Gene Ontology) standards have been adopted for protein naming conventions. 2. CONTRACTS MANAGEMENT AND ADMINISTRATION 2.1. CURRENT BUDGET SUMMARY The budget summary for FY19 is provided in Table 2.1-1. Table 2.1-2 provides FY19 to-date costs against FY19 Annual Work Plan Estimates. Detailed subcontractor spending is provided in the associated Q4 financial report. MVDP Quarterly Report 2 Leidos Proprietary MVDP Quarterly Report 3 Leidos Proprietary Table 2.2-1. Deliverable Summary Deliverable/Work ID* Actions/Status Notes Product CONTRACTS AND ADMINISTRATION Signed: 5/28/15 Modifications: MOD 1 2/22/16 MOD 2 3/4/16 MOD 3 8/16/16 MOD 4 2/13/17 MVDP Operations Manager key personnel Prime Contract MOD 5 5/1/17 approval notice received 9/13/19. MOD 6 7/18/17 MOD 7 9/28/17 MOD 8 1/09/18 MOD 9 12/20/18 MOD 10 3/1/19 Contractor – Employee Non- Disclosure/Conflict Signed Non-Disclosure/COI Agreements i. Delivered of Interest (COI) are located on SharePoint. Agreements Delivered: 09/3/19 ii. Annual Work Plan Approved: Q1 FY19 Delivered: 01/14/19 vi. Quarterly Reports Q2 FY19 Delivered: 04/15/19 Upcoming Reports: 01/14/2020 Q3 FY19 Delivered: 07/15/19 Q1 FY19 Delivered: 01/14/19 Quarterly Financial vii. Q2 FY19 Delivered: 04/15/19 Upcoming Reports: 01/14/2020 Reports Q3 FY19 Delivered: 07/15/19 Delivered: 10/14/19 viii. Annual Report/Q4 Report Approved: Delivered: The Small Business Small Business H.10.a Subcontracting Plan was Subcontracts Subcontracting Plan included in Leidos’ proposal. Due: Annually in October; Individual Subcontract H.10.b.1 submitted via eSRS by Leidos’ Upcoming Reports: 10/30/18 Reports Small Business Liaison office. Due: Annually in October; Summary Subcontract Upcoming Report: 10/30/19 H.10.b.2 submitted via eSRS by Leidos’ Report Small Business Liaison office. Final Overall Contract ix. N/A Upcoming Report: 5/27/20 Report Held: See Table 2.4-1. Upcoming Meetings: Regularly Biweekly USAID–Leidos C.4.4 Ad hoc meetings held: See scheduled biweekly meetings are held the Update Meetings Table 2.4-1. first and third Wednesdays of each month. Contract Administration Meetings with No actions in the reporting G.4.C Contracting Officer’s period. Representative (COR) MVDP Quarterly Report 4 Leidos Proprietary Table 2.2-1. Deliverable Summary Deliverable/Work ID* Actions/Status Notes Product Due: All contracts and Upon approval of all future deliverables, USAID Development administration deliverables will Leidos will upload to the DEC. At xiv. Experience Information be uploaded to the DEC after contract completion, Leidos will upload all 30 days from approval. task-associated documents as well. ELEMENT 1: PROTOCOL DEVELOPMENT/WHITE PAPERS See section 3.2 regarding abstract/poster xii. Publications/Posters Q1 FY2019: 4 posters submissions. C.3.2.2 New Project Proposals None in the reporting period ELEMENT 2: IMPLEMENTATION OF RESEARCH AND DEVELOPMENT PROJECTS CSP Vaccine Development Project Project Plan approved by USAID on Final Individual Project iii. Approved 1/29/16. descriptions Revised Project Plan approved 04/26/2017. Q1 FY2019: procurement activities Subcontract/Task Order completed for IMV, JHU, VaxDesign, and Awards: VLP Biotech, JHU, VLP Biotech. ADARC, EpiVax, Precision Subcontracts: Q2 FY2019: procurement completed for Antibody, ImmunoVaccine, xii. Procurement of Materials, VaxDesign and ongoing for JHU. VaxDesign Supplies, and Services Q3 FY2019: procurement completed for Other Procurement JHU (passive transfer study). Vehicles: CPC Scientific, Q4 FY2019: procurement completed for Vaxine JHU (passive transfer study) Final Individual Project iv. — Report VLP Biotech Quarterly Reports VLP162 + DPX4 Stability Study Documentation Individual Project Data Provided herein, circulated via email v. (ImmunoVaccine) Sets and/or uploaded to SharePoint. VaxDesign Data Slides CSP Project Update Slides JHU Study Data See section 3.2 regarding abstract/poster xii. Publications None during reporting period. submissions. ix. Other/Ad Hoc Reports — RH5.1/AS01 Vaccine Clinical Study Final Individual Project Plan approved by USAID on iii. Approved Project descriptions 2/17/16. Q1 FY2019: procurement for recently approved activities is ongoing for Oxford. Subcontract/Task Order Procurement of Materials, Q2 FY2019: Oxford procurement xii. Awards: University of Oxford, Supplies, and Services completed. EpiVax Q3 FY2019: none Q4 FY2019: none Final Individual Project iv. — Report MVDP Quarterly Report 5 Leidos Proprietary Table 2.2-1. Deliverable Summary Deliverable/Work ID* Actions/Status Notes Product Schedule and regulatory approvals for late Individual Project Data Provided herein, circulated via email, v. immunogenicity time point Set and/or uploaded to SharePoint. Oxford quarterly reports Oxford data updates See section 3.2 regarding abstract/poster xii. Publications None during reporting period. submissions. ix. Other/Ad Hoc Reports — Trial registered on September 5, 2016 xii. Registration of Trials Completed (ClinicalTrials.gov) Liver Stage Vaccine Development Project Project Plan approved by USAID on Final Individual 6/13/16. Attachment 1 - CD8 platform iii. Approved Project descriptions scouting plan approved by USAID on 6/6/19. Q2 FY2019: procurement completed for Subcontract Awards: SGI (kickoff held 3/27/2019) and GeoVax EpiVax, VaxDesign, Precision Procurement of Materials, (kickoff held 3/7/19). xii. Antibody, Multimeric Supplies, and Services Q3 FY2019: procurement completed for BioTherapeutics, ADARC, ADARC (MVA construct testing). GeoVax Q4 FY2019: none Final Individual Project iv. — Report Individual Project Data VaxDesign, ADARC and Provided herein, circulated via email v. Set GeoVax data sets and/or uploaded to SharePoint. See section 3.2 regarding abstract/poster xii. Publications None during reporting period. submissions. Data report for CRADA with ix. Other/Ad Hoc Reports Leidos/NMRC data exchange NMRC RCR Complex Vaccine Development Project-WEHI Final Individual Project Project Plan approved by USAID on iii. Approved descriptions 3/21/2019. Q1 FY2019: procurement ongoing with WEHI, SGI, and Precision Antibody Q2 FY2019: Procurement completed for IMV (W2), SGI (kickoff meeting held Pending: WEHI (W3), IMV 3/27/19) and Precision Antibody; ongoing (W3) for WEHI (W2) Procurement of Materials, Q3 FY2019: Procurement completed for xii. Subcontract/Task Order Supplies, and Services Awards: WEHI (W2 in Q3), WEHI (W2); Kickoff meeting with ImmunoVaccine (W2 in Q2), Precision Antibody held in May 2019. SGI and Precision Antibody task order discontinued. Q4 FY2019: Procurement ongoing for WEHI Q4 FY2019: Procurement completed for IMV (W3). MVDP Quarterly Report 6 Leidos Proprietary Table 2.2-1. Deliverable Summary Deliverable/Work ID* Actions/Status Notes Product Final Individual Project iv. — Report Preliminary ELISA dataset for Study W1 Repeat ELISA dataset for Study W1 The preliminary ELISA dataset was GIA for Study W1 circulated to USAID and the repeat ELISA Preliminary ELISA dataset for was discussed in the biweekly meeting and Individual Project Data Study W2 provided herein. v. Set Repeat ELISA dataset for Study An IPT meeting was conducted to discuss W2 Test Bleed WEHI W1/W2 ELISA and GIA results on ELISA dataset for Study W2 September 17, 2019 (US/UK)/September Terminal Bleed 18, 2019 (AUS). Repeat RH5 ELISA for Study W2 GIA-LDH for Study W1 See section 3.2 regarding abstract/poster xii. Publications None during reporting
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