The World Bank Implementation Status & Results Report HIV Vaccine Research and Development (P167064) HIV Vaccine Research and Development (P167064) OTHER | World | Health, Nutrition & Population Global Practice | Recipient Executed Activities | Investment Project Financing | FY 2019 | Seq No: 1 | ARCHIVED on 26-Apr-2019 | ISR36624 | Implementing Agencies: International AIDS Vaccine Initiative, International AIDS Vaccine Initiative Key Dates Key Project Dates Bank Approval Date: 23-Jan-2019 Effectiveness Date: 01-Feb-2019 Planned Mid Term Review Date: -- Actual Mid-Term Review Date: -- Original Closing Date: 30-Jun-2021 Revised Closing Date: 30-Jun-2021 pdoTable Project Development Objectives Project Development Objective (from Project Appraisal Document) To develop and characterize viable HIV vaccine candidate(s) and other potential viral vectors as basic research for new technologies against infectious diseases of poverty. Has the Project Development Objective been changed since Board Approval of the Project Objective? No Components Table Name 1. Research and Development (R&D):(Cost $5.37 M) 2. Knowledge Dissemination and Coordination (non-R&D):(Cost $0.38 M) Overall Ratings Name Previous Rating Current Rating Progress towards achievement of PDO -- Satisfactory Overall Implementation Progress (IP) -- Satisfactory Overall Risk Rating -- Low Implementation Status and Key Decisions The Project was approved in late January 2019 and the grant agreement was signed in February. Therefore, it is too early to report any progress thus far. The first implementation support mission is planned in June 2019 at IAVI's research laboratory in New York in order to review the progress of R&D activities. IAVI successfully co-organized a symposium titled “Accelerating Innovation and Access in Global Health Technologies: The latest progress in the fight against infectious diseases,” in Tokyo on February 25, 2019. The event was planned and implemented with Coalition for Epidemic Preparedness Innovations and Global Health Innovative Technology Fund. The co-hosts of the symposium also included the Foundation for Innovative New Diagnostics and Mitsubishi UFJ Research and Consulting to create a synergy with diagnostics advocacy and to strengthen private sector involvement. The summary of the discussions will shortly be available in English and Japanese. 4/26/2019 Page 1 of 7 The World Bank Implementation Status & Results Report HIV Vaccine Research and Development (P167064) Risks Systematic Operations Risk-rating Tool Risk Category Rating at Approval Previous Rating Current Rating Political and Governance Low -- Low Macroeconomic Low -- Low Sector Strategies and Policies Low -- Low Technical Design of Project or Program Moderate -- Moderate Institutional Capacity for Implementation and Sustainability Low -- Low Fiduciary Moderate -- Moderate Environment and Social Moderate -- Moderate Stakeholders Low -- Low Other -- -- -- Overall Low -- Low Results PDO Indicators by Objectives / Outcomes Project Development Objective IN00690074 ►1.1 VSV-∆G (HIV.Env) vector fully characterized including in immunological, genetic and cellular propagation aspects (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Jun-2021 VSV-∆G (HIV.Env) vector fully characterized including in immunological, genetic and cellular propagation Comments: aspects IN00690075 ►1.2.Two further novel vectors (VSV(NJ) and a novel VSV-like vector) constructed and characterized (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Jun-2021 Comments: Two further novel vectors (VSV(NJ) and a novel VSV-like vector) constructed and characterized IN00690076 4/26/2019 Page 2 of 7 The World Bank Implementation Status & Results Report HIV Vaccine Research and Development (P167064) ►1.3.GMP compliant cell line for use in manufacturing of VSV-based HIV vaccine vectors produced (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Jun-2021 Comments: GMP compliant cell line for use in manufacturing of VSV-based HIV vaccine vectors produced IN00690077 ►2.Joint learning events and meeting outputs developed with global partners in vaccine R&D for potential epidemic diseases and diseases of poverty (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Jun-2021 Joint learning events and meeting outputs developed with global partners in vaccine R&D for potential Comments: epidemic diseases and diseases of poverty Intermediate Results Indicators by Components 1.1 Detailed immunologic and transcriptomics analysis on samples collected from studies IN00690078 ►1.1.a Primary sample analysis, antibody titers (Elisa) and T-cell from animals immunized with the VSV∆G-Env vector completed. (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Sep-2019 Primary sample analysis, antibody titers (Elisa) and T-cell from animals immunized with the VSV∆G-Env Comments: vector completed. IN00690082 ►1.1.b Advanced characterization of Env-specific serum antibodies induced by vaccination completed incl. epitope specificity determination by binding and competition assays & evaluation of effects (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Sep-2020 Advanced characterization of Env-specific serum antibodies induced by vaccination completed incl. Comments: epitope specificity determination by binding and competition assays & evaluation of sieve effects IN00690086 ►1.1.c Analysis of blood transcriptomic profiles at select time points after vaccination completed and how vaccination affects modular gene sets such as those connected to B- and T-cell responses etc. (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Sep-2019 4/26/2019 Page 3 of 7 The World Bank Implementation Status & Results Report HIV Vaccine Research and Development (P167064) Analysis of blood transcriptomic profiles at select time points after vaccination completed and how Comments: vaccination affects modular gene sets such as those connected to B- and T-cell responses etc. IN00690090 ►1.1.d A pre-master virus seed (pre-MVS) that supports future cGMP manufacturing derived, if VSV∆G-Env produces preclinical data superior to the original VSV∆G-Env chimeric virus vaccine. (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Sep-2020 A pre-master virus seed (pre-MVS) that supports future cGMP manufacturing derived, if VSV∆G-Env Comments: produces preclinical data superior to the original VSV∆G-Env chimeric virus vaccine. 1.2 Research on development of a cell line supporting GMP manufacturing of G-pseudo. VSV∆G-ENV IN00690079 ►1.2.a Technical feasibility of two approaches to producing a VSV G pseudotyping cell including: G expression following extended cell passage and ability to propagate VSV∆G-Env vector determined. (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Sep-2019 Technical feasibility of two approaches to producing a VSV G pseudotyping cell including: G expression Comments: following extended cell passage and ability to propagate VSV∆G-Env vector determined. IN00690083 ►1.2.b Technical feasibility of ( a)DNA expression construct encoding alternative G glycoprotein less cytotoxic (b)DNA expression construct encoding alternative viral glycoprotein & supports VSV pseudo (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Sep-2020 Technical feasibility of ( a)DNA expression construct encoding alternative G glycoprotein less cytotoxic Comments: (b)DNA expression construct encoding alternative viral glycoprotein & supports VSV pseudo IN00690087 ►1.2.c A GMP compliant cell line of for use in GMP manufacturing of VSV based HIV vaccine vectors produced, if the pseudotyping cell line has been demonstrated to be feasible. (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Jun-2021 A GMP compliant cell line of for use in GMP manufacturing of VSV based HIV vaccine vectors produced, Comments: if the pseudotyping cell line has been demonstrated to be feasible. 1.3. Construction and characterization of two VSV-like vectors IN00690080 ►1.3.a A VSV(NJ)∆G-Env vector shown to have replicative capacity equivalent to the original VSV∆G-Env counterpart based on VSV(IND) constructed. (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes 4/26/2019 Page 4 of 7 The World Bank Implementation Status & Results Report HIV Vaccine Research and Development (P167064) Date 01-Oct-2018 -- 23-Apr-2019 30-Sep-2019 A VSV(NJ)∆G-Env vector shown to have replicative capacity equivalent to the original VSV∆G-Env Comments: counterpart based on VSV(IND) constructed. IN00690084 ►1.3.b A second vector platform for further evaluation & development from among, but not limited to VSVlike viruses (Cocal, Carajas, Maraba) or other more immunologically distant relatives identified (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Sep-2019 A second vector platform for further evaluation & development from among, but not limited to VSVlike Comments: viruses (Cocal, Carajas, Maraba) or other more immunologically distant relatives identified IN00690088 ►1.3.c In addition to VSV(NJ), a second new vector developed and characterized based on an immunologically distant VSV- like virus to be determined after database sequence comparison. (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Sep-2020 In addition to VSV(NJ), a second new vector developed and characterized based on an immunologically Comments: distant VSV-like virus to be determined after database sequence comparison. IN00690091 ►1.3.d If appropriate based on result from 3.a and 3.c, (up to) two new vector backbone (HIV.Env) candidates selected for use in vaccine development used to product material comparable to the research (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Jun-2020 If appropriate based on results from 3.a and 3.c, (up to) two new vector backbone (HIV.Env) candidates Comments: selected for use in vaccine development used to product material comparable to the research 2. Strengthening coordination among key global stakeholders to promote further engagements IN00690081 ►2.a Joint meetings to reach out to potential global partners organized three times. (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Jun-2020 Comments: Joint meetings to reach out to potential global partners organized three times. IN00690085 ►2.b Communication material for global partners developed. (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Sep-2019 4/26/2019 Page 5 of 7 The World Bank Implementation Status & Results Report HIV Vaccine Research and Development (P167064) Comments: Communication material for global partners developed. IN00690089 ►2.c Field visit(s) by potential global partners organized. (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No -- No Yes Date 01-Oct-2018 -- 23-Apr-2019 30-Sep-2020 Comments: Field visit(s) by potential global partners organized. Data on Financial Performance Disbursements (by loan) Project Loan/Credit/TF Status Currency Original Revised Cancelled Disbursed Undisbursed % Disbursed P167064 TF-A9266 Effective USD 5.75 5.75 0.00 0.00 5.75 0%% Key Dates (by loan) Project Loan/Credit/TF Status Approval Date Signing Date Effectiveness Date Orig. Closing Date Rev. Closing Date P167064 TF-A9266 Effective 23-Jan-2019 01-Feb-2019 01-Feb-2019 30-Jun-2021 30-Jun-2021 Cumulative Disbursements 4/26/2019 Page 6 of 7 The World Bank Implementation Status & Results Report HIV Vaccine Research and Development (P167064) Restructuring History There has been no restructuring to date. Related Project(s) There are no related projects. 4/26/2019 Page 7 of 7