Sources Sought Notice Information

Introduction

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

Background

In 2019, to advance research and development of promising new influenza vaccines that provide broader and more durable protection and immunity, NIAID supported a coordinated multi-disciplinary effort under Research Area 003 of the Broad Agency Announcement (BAA) HHS-NIH-NIAID-BAA2018 that established the NIAID Collaborative Influenza Vaccine Innovation Centers (CIVICs) program. An additional contract was awarded under RFP-NIAID-DAIT-NIHAI201800018 for the CIVICs Statistical, Data Management and Coordination Center (SDMCC) to provide statistical analysis, pre-clinical and clinical data management, and study coordination services. 

The overarching goals of the CIVICs program included: (1) supporting improvements in the immunogenicity and durability of seasonal influenza vaccines; (2) developing innovative influenza vaccine approaches that provide robust, durable, broadly protective mucosal and systemic anti-influenza immunity; and (3) conducting iterative vaccine design based on detailed immunologic assessment of influenza vaccine candidates through preclinical animal studies, early phase clinical trials, and healthy volunteer controlled human infection studies.

The CIVICs program made significant progress during the current funding period, including:  conduct of several Phase 1 clinical trials to assess vaccine candidates; conduct of clinical trials of additional human influenza challenge viruses (dose-finding studies); GMP manufacturing of additional vaccine candidates; ongoing process development studies with several Phase 1 trials being planned for 2025; and pre-clinical assessment of numerous promising influenza vaccine candidates.

SDMCC accomplishments include the development and launch of:

The CIVICs public website: https://www.niaidcivics.org.

Development of data standards and a data submission and validation pipeline for the CIVICs program that facilitated submission of CIVICs-generated data to public repositories, including submission of over 22 studies, involving more than 2,600 subjects, to the ImmPort public repository (www.Immport.org).

A single ecosystem, termed the SDMCC Private Portal, which provides a Single-Sign-On (SSO) solution infrastructure connected it to a Nextcloud collaboration platform, which is used by the CIVICs investigators and NIAID for sharing internal documents, resources, and reagents across the program.

CIVICs database models for collection and sharing of CIVICs-generated research data. This database system consists of an Amazon Web Service (AWS) DynamoDB, which is a NoSQL database that supports both key value and document data models. DynamoDB is made available through AWS Cloud as a fully managed serverless service that automatically scales to accommodate demand.

CIVICs Data Submission portal, which is part of the Nextcloud platform and is being used by the CIVICs investigators to submit research data and associated meta-data.

CIVICs Data Standards and Data submission templates. These standards and templates are based upon those created and used by the ImmPort data repository (https://www.immport.org ), which serves as the primary public repository for CIVICs-generated datasets.

The CIVICs program is being recompeted (NIAID-DAIT-NIHAI201800018), with an anticipated award date in or around July 2026. 

The renewed CIVICs program is anticipated to include at least four (4) Vaccine Centers that are responsible for comprehensive design, development, and immunologic evaluation of candidate influenza vaccines. To simplify the CIVICs program, the re-competition will not include separate Clinical Cores.  These activities will be supported by existing clinical infrastructure and programs at NIAID. Furthermore, the re-competition will not support a separate Manufacturing and