Clinical Trial Research - for HIV and related common co-infections

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), Military HIV Research Program (MHRP) Subject: Clinical Trial Research - for HIV and related common co-infections. This This Request for Information (RFI)/Sources Sought (SS) Notice is for market research, information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of Walter Reed Army Institute of Research (WRAIR) or the US Army Medical Research Acquisition Activity (USAMRAA). This market research is seeking sources only that have the knowledge and capabilities to conduct Good Clinical Practices (GCP) for the studies in HIV and related co-infections. The research sites particularly include locations Outside the Continental United States (OCONUS). The NAICS code for this requirement is 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Only capability statements and/or fact sheets will be accepted. DISCLAIMER: This RFI is NOT a Request for Proposals (RFP) or a Request for Quotations (RFQ); This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Responses to the RFI will not be returned. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. No Contract will be awarded from this announcement. No reimbursement will be made of any costs to provide information in response to this announcement or any follow up information requests. Responders are solely responsible for all expense associated with responding to this RFI. Availability of any formal solicitation will be announced under a separate announcement. All information received in response to this RFI will be treated as business confidential information. Submitters should properly mark their responses if the information is confidential. All information received in response to this RFI that is marked Proprietary will be handled accordingly. At this time, questions concerning the composition and requirements for a future RFP will not be entertained. Background: The MHRP is a globally recognized leader in HIV research from basic and preclinical science, through phase 1 development to advanced clinical trials and requires the collaboration of an equivalent level leader in HIV scientific and medical science to design, conduct, and manage research and early development focused on developing new medical products and countermeasures that will advance the program toward the goal of defeating HIV. Scope: Ongoing studies plan and execute some new studies. Develop the research agenda focused on HIV medical countermeasures and will plan and execute to those objectives. As a research effort, there will be USG involvement in all aspects of developing the research program and scientific/medical means and approaches to advance toward the MHRP objectives. Research Objectives: Perform basic research through early pre-clinical and clinical development focused on HIV and related STIs and common co-infections of HIV. This requirement pertains directly to MHRP projects that are part of an intra-Government collaboration between MHRP and the Division of AIDS within NIAID/NIH. The Awardee shall design and conduct research and provide the inherent operational and technical support to ensure its success. Overall objective of this effort is to advance the scientific and medical state of the art to overcome the threat of HIV infection, the expected results will be new scientific knowledge, techniques, and candidate MCMs (i.e., prototypes) that may be further selected for continued Product Development (PD) under separate contracts or agreements. Study and Site General Requirements: Kenya, Uganda, Tanzania, Thailand, and other locations to be determined) Clinical Trials/Research include but not limited to: Cohort Observational Study for characterization of acute HIV infections. Monitoring Study to ensure the safety of HIV-infected volunteers who complete HIV remission trials that include an analytic treatment interruption (ATI) or other experimental interventions hypothesized to affect the size of the HIV reservoir. Administration of Acute HIV Infection in a placebo-controlled Phase 1 clinical trial evaluating the safety and virologic effect of a monoclonal antibody (VRC01) alone or in combination with antiretroviral therapy (ART) against early acute HIV infection. Prospective observational cohort study of HIV incidence and prevalence rates in Kenya enrolling HIV uninfected participants and those who are high risk for HIV infection. The enrollment of participants at high risk for HIV to investigate the HIV and STI incidence and establish a cohort. Clinical operations support and coordinating group that will perform, oversee, and manage clinical operations functions to ensure startup, conduct, and management of clinical studies/trials under this award to ensure efficiency and consistency of efforts across the research portfolio. Provide extensive and comprehensive knowledge of pharmaceutical/vaccine project management; laboratory and clinical operations; and international site development in order to coordinate the research and development efforts. Instructions to Responders: Respondents should address how they best can fulfil the requirements set forth above in their capabilities statement. Capability Statements or any other proprietary information relative to this RFI should adhere to the following formatting and outline instructions: 1. All submissions shall be made electronically and be in one of the following formats: Microsoft Word or Adobe PDF and shall not exceed 5 pages. 2. Please note that the response shall be sufficiently detailed. 3. The requested information shall be submitted via email. The point of contact for this action is Jennifer Jackson, Contracting Officer/Agreements Officer, email: jennifer.c.jackson18.civ@mail.mil. Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE.