PRECLINICAL AND TRANSLATIONAL VACCINE DEVELOPMENT FOR HIV AND OTHER CANDIDATE AGENTS   8

The development of a safe and efficacious preventive HIV-1 vaccine is one of the highest priorities of the National Institute of Allergy and Infectious Diseases (NIAID). NIAID supports a portfolio of preclinical, translational, and clinical research to advance HIV vaccine efforts. The Division of AIDS (DAIDS) supports research programs to discover novel vaccine strategies, assess correlates of immunogenicity and of protections elicited by experimental vaccines and provides an infrastructure for the manufacturing and testing of novel products. To achieve this goal, the Government anticipates awarding Indefinite Delivery/Indefinite Quantity (IDIQ) contracts to multiple Contractors that meet the overall qualifications for individual Task Areas.

There are two current single-award IDIQ contracts that provide preclinical services for HIV Vaccine efforts ranging from initial product discovery through full current Good Manufacturing Practices (CGMP) manufacturing and readiness for clinical trials and/or product licensure.

Contract No. HHSN272201700010I, with Advanced BioScience Laboratories, Inc. (ABL), entitled NIAID Preclinical Development Support was awarded in June 2017 as a single award IDIQ type contract for a period of seven years (6/10/2017 through 6/9/2024) and a maximum quantity of $318,500,000.00.

Contract No. HHSN272201600011I, with the International AIDS Vaccine Initiative (IAVI), entitled NIAID Process and Analytical Support for Development of HIV Vaccines was awarded in July 2016 as a single-award IDIQ type contract for a period of seven years (7/15/2016 through 7/14/2023) and a maximum quantity of $98,587,183.00

The current Contractors have provided preclinical services including: manufacturing feasibility assessments, analytical characterization and method development, audits, regulatory documentation, process development and current Good Manufacturing Practices (CGMP) manufacturing, and safety and immunogenicity studies. Additional services have included project management, technical support, quality assurance, product shipping and storage, and document management.

Changes to the contract requirements from previous IDIQ single-award competitions include use of the multiple award structure and incorporating activities currently found in the Essential Core Activities Task Area into each Task Order in the new awards.

The purpose of this solicitation is to award multiple IDIQ contracts to support the full range of activities for preclinical and translational support services from initial product discovery through full (CGMP) manufacturing and readiness for clinical trials and/or product licensure.

The contracts will support tasks in the following areas:

Research and Development Product Storage and Shipping (Task Area A)

Safety and Immunogenicity Studies (Task Area B)

Feasibility Studies and Early Manufacturability Assessments (Task Area C)

Analytical Characterization and Method Development (Task Area D)

Process Development, CGMP Manufacturing, and Stability (Task Area E)

Fill-Finish, Packaging, and Labeling (Task Area F)

Scientific, Quality, and Regulatory Support Services (Task Area G)

NIAID anticipates Task Orders issued against the IDIQ contracts will be cost reimbursement and/or firm fixed price. While the Base IDIQ contracts will not have options, options may be included at the individual Task Order level.

It is anticipated that NIAID will award Base contracts to one or multiple contractors for each of the Task Areas A, B, C, D, E, F, and G. Task Area G is set aside for small business concerns.