SOW redacted - Emergent.pdf

ATTACHMENT 1: STATEMENT OF WORK

Title: Extension of Stability Testing Program for Two HIV Vaccine Candidates

1.0 INTRODUCTION/OVERVIEW

The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. NIAID has a unique mandate, which requires the Institute to respond to emerging public health threats. The Division of AIDS (DAIDS) is a program within NIAID. The DAIDS was formed in 1986 to develop and implement the national research agenda to address the HIV/AIDS epidemic. Toward that end, the division supports a global research portfolio to advance biological knowledge of HIV/AIDS, its related co-infections, and co-morbidities. With the ultimate goal of creating an “AIDS-Free Generation,” the division develops and supports the infrastructure and biomedical research needed to: 1) halt the spread of HIV through the development of an effective vaccine and biomedical prevention strategies that are safe and desirable; 2) develop novel approaches for the treatment and cure of HIV infection; 3) treat and/or prevent HIV co-infections and co-morbidities of greatest significance; and 4) partner with scientific and community stakeholders to efficiently implement effective interventions.

Under an on-going NIAID sponsored program, the Contractor previously developed and manufactured two clinical scale adenoviral vectored HIV vaccine candidates. These two vaccine candidates are under investigation in a Phase 1 clinical study for which enrollment is ongoing. The trial was temporarily paused due to resources being diverted for COVID and has since resumed enrollment. However, this delay in enrollment has extended the timelines for the completion of the trial, requiring an extension of the stability testing program to assure the safety and stability of the products in trial until a year after the completion of the enrollment. In addition, one of the investigational vaccine candidates has also been approved for use in another NIAID-sponsored clinical study to be conducted by the NIAID-funded HIV Vaccine Trials Network (HVTN308). The original contract has ended but the Stability Program needs to be continued until past the last vaccination of the trial participant. The purpose of this contract is to extend the stability programs of the two adenoviral vectored HIV vaccine candidates already being tested in the clinical trial to account for delays in enrollment due to COVID. The other clinical trial being planned with these two vaccine candidates will likely take 3-4 years to complete. Thus, the product stability program for these Adeno products needs to be extended for 4 more years annually than originally planned.

The FDA requires product stability studies to be performed yearly to ensure that the product retains purity, potency, and safety characteristics when stored at specified conditions during ongoing clinical studies.

2.0 BACKGROUND

Under an on-going NIAID sponsored program, the Contractor developed and manufactured two clinical scale adenoviral vectored HIV vaccines. These two vaccine candidates are under investigation in Phase 1 clinical study, enrollment for which is ongoing. The trial was temporarily stopped in the middle due to the resources being diverted for COVID and has resumed enrollment since. However, this delay and slow enrollment has extended the timelines for the completion of the trial, requiring the Program to extend the stability testing program for assuring the safety and stability of the products in trial until past a year after the completion of the enrollment. In addition, one of the investigational vaccine candidates has been approved for use in another NIAID sponsored clinical study to be conducted by the NIAID funded HIV Vaccine Trials Network (HVTN308)

The anticipated period of performance will be for one (1) base year with four (4) option years. The option years may be exercised at the discretion of the Government.

6.0 PLACE OF PERFORMANCE

The contractor shall perform the testing in their facilities, providing equipment and resources.

7.0 GOVERNMENT FURNISHED EQUIPMENT AND FACILITIES

7.1 Facilities, Supplies and Services

Contractor shall provide the facility and the materials required, oversight, and quality assurance for the release of the COA, COC, and stability report.

7.2 Information

The Government will provide information, materials, and forms unique to the Government for supporting the work. All Government unique information related to this requirement, which is necessary for Contractor performance, will be made available to the Contractor. The COR will be the point of contact for identification of any required information to be supplied by the Government.

7.3 Documentation

All existing documentation, relevant to the required work, will be made available to the Contractor. The Contractor will be required to prepare documentation in accordance with defined guidelines provided by the Government.