This Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP-HTM) brings together a network of investigators representing two companies and five academic institutions to perform multidisciplinary preclinical and exploratory clinical studies with the goal of advancing a safe, novel trivalent topical microbicide, mapp66. This microbicide formulation is comprised of three monoclonal antibodies (Mabs), produced by genetic engineering in Nicotiana benthamiana (-N), that are designed to block distinct mechanisms of HIV sexual transmission. Success of this IPCP-HTM will rely upon an Administrative Core (Core A) that will provide scientific and administrative leadership in coordinating the six Scientific Projects, and the multiple sites that make up this IPCP-HTM program. The Administrative Core will also coordinate data and materials acquisition and sharing so that the research progresses in an integrated iterative fashion to meet individual project and programmatic milestones.
The Specific Aims of the Administrative Core are: 1. To provide scientific leadership and administrative oversight. Specifically, Core A will establish an Executive Committee (EC) for ongoing assessment of project and core milestones, resource allocation and changes to the experimental design. Core A will also convene a Scientific Advisory Panel (SAP) to review the program in years 3 and 5. Core A will facilitate communication through scheduled conference calls and investigator meetings, provide financial and administrative support, and insure adherence to institutional and federal guidelines 2. To coordinate data and materials acquisition and sharing to insure that project and program milestones are met. Specifically, Core A will be responsible for the reagent/research material and data management and sharing plan, for monitoring milestone achievements and coordinating biostatistical services, if required by the individual projects/cores.

Public Health Relevance

This Integrated Preclinical/Clinical Program for HIV Topical Microbicides will develop a combination monoclonal antibody product for use as a vaginal microbicide to protect against sexually transmitted infections, including HIV/AIDS and HSV/genital herpes.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
5U19AI096398-03
Application #
8515318
Study Section
Special Emphasis Panel (ZAI1-ESB-A)
Project Start
Project End
Budget Start
2013-08-01
Budget End
2014-07-31
Support Year
3
Fiscal Year
2013
Total Cost
$306,138
Indirect Cost
$38,117
Name
Boston University
Department
Type
DUNS #
604483045
City
Boston
State
MA
Country
United States
Zip Code
02118
Anderson, Deborah J; Politch, Joseph A; Zeitlin, Larry et al. (2017) Systemic and topical use of monoclonal antibodies to prevent the sexual transmission of HIV. AIDS 31:1505-1517
Daggett Jr, Gregory J; Zhao, Chunxia; Connor-Stroud, Fawn et al. (2017) Comparison of the vaginal environment in rhesus and cynomolgus macaques pre- and post-lactobacillus colonization. J Med Primatol 46:232-238
Zhao, Chunxia; Gunawardana, Manjula; Villinger, Francois et al. (2017) Pharmacokinetics and Preliminary Safety of Pod-Intravaginal Rings Delivering the Monoclonal Antibody VRC01-N for HIV Prophylaxis in a Macaque Model. Antimicrob Agents Chemother 61:
Henry, Christine E; Wang, Ying-Ying; Yang, Qi et al. (2016) Anti-PEG antibodies alter the mobility and biodistribution of densely PEGylated nanoparticles in mucus. Acta Biomater 43:61-70
Wessler, Timothy; Chen, Alex; McKinley, Scott A et al. (2016) Using Computational Modeling To Optimize the Design of Antibodies That Trap Viruses in Mucus. ACS Infect Dis 2:82-92
Ayehunie, Seyoum; Islam, Ayesha; Cannon, Chris et al. (2015) Characterization of a Hormone-Responsive Organotypic Human Vaginal Tissue Model: Morphologic and Immunologic Effects. Reprod Sci 22:980-90
Wang, Ying-Ying; Nunn, Kenetta L; Harit, Dimple et al. (2015) Minimizing biases associated with tracking analysis of submicron particles in heterogeneous biological fluids. J Control Release 220:37-43
Nunn, Kenetta L; Wang, Ying-Ying; Harit, Dimple et al. (2015) Enhanced Trapping of HIV-1 by Human Cervicovaginal Mucus Is Associated with Lactobacillus crispatus-Dominant Microbiota. MBio 6:e01084-15
Chen, Alex; McKinley, Scott A; Shi, Feng et al. (2015) Modeling of Virion Collisions in Cervicovaginal Mucus Reveals Limits on Agglutination as the Protective Mechanism of Secretory Immunoglobulin A. PLoS One 10:e0131351
Anderson, Deborah J; Politch, Joseph A (2015) Role of Seminal Plasma in Human Female Reproductive Failure: Immunomodulation, Inflammation, and Infections. Adv Exp Med Biol 868:159-69

Showing the most recent 10 out of 27 publications