Online recruitment campaign for an influenza virus seasonal epidemic and pandemic Phase 1 study

PRE-SOLICITATION NOTICE – NOTICE OF INTENT TO SOLE SOURCE

NOI-NIAID-25-2251388

NAICS – 541810, Advertising Agencies

This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with BuildClinical, LLC of New York, NY to procure an online recruitment campaign for an influenza virus seasonal epidemic and pandemic Phase 1 open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of mosaic hexavalent influenza vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) with and without Army Liposome Formulation containing saponin QS-21 (ALFQ) adjuvant.

NIAID conducts many clinical trials at the NIH Clinical Center, America’s research hospital, which is located on the main campus in Bethesda, Maryland. NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world. NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. Influenza virus causes seasonal epidemics and pandemics at irregular intervals that result in significant morbidity and mortality. According to the World Health Organization (WHO) the annual epidemics result in 3 to 5 million cases of severe illness and about 290,000 to 650,000 respiratory deaths. The Center for Disease Control (CDC) estimates that during the 2019-2020 influenza season, there were 56 million illnesses, 26 million medical visits, 740,000 hospitalizations, and 62,000 deaths in the United States (US). Despite the annual influenza vaccination campaigns, influenza has continued to be a major public health concern in the US. The estimated average annual total economic burden of influenza to the healthcare system and society in the US was $6.3–$25.3 billion. The preferred method of reducing the incidence, morbidity, and mortality of influenza remains prevention of the disease through vaccination. Influenza vaccination reduces productive time lost due to illness, and it is the most cost-effective medicine intervention that yields health benefits among all age groups, especially among high-risk populations. Various forms of influenza virus vaccines have been used for this purpose since the 1940’s; however, as of today, there are no influenza vaccines that are highly cross-reactive across influenza viruses. With the goal of developing a universal influenza vaccine, the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) has developed a mosaic nanoparticle vaccine that may provide durable and cross-strain protection against different influenza viruses. Underway is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of mosaic hexavalent influenza vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) with and without Army Liposome Formulation containing saponin QS-21 (ALFQ) adjuvant. The hypotheses are that the FluMos-v2 vaccine is safe and tolerable when administered alone or with ALFQ adjuvant, that this vaccine elicits antigen-specific immune responses, and that addition of the ALFQ adjuvant increases the magnitude and breadth of the elicited immune responses. The primary objective is to evaluate the safety and tolerability of the investigational vaccine with and without ALFQ adjuvant in healthy adults. Secondary objectives are related to the immunogenicity of the investigational vaccine with and without ALFQ adjuvant. Needed is a recruitment for a Phase I clinical trial with healthy adults (n=35 with enrollment of up to 45 allowed), between the ages of 18-50 years; Body Mass Index (BMI) ≤ 35; agrees to not receive the 2023-2024 licensed influenza vaccination during study participation; agrees to not receive the 2024-2025 or 2025-2026 licensed influenza vaccination during study participation. BuildClinical is a company that will optimally deploy advertisements across web platforms to engage our specific patient population via their patient advertising network and provide usage of their management tools and reporting services. Historically, recruitment has to be done by an NIH recruitment team, however, NIH is extremely concerned that they will not be able to recruit a sufficient number of study participants who meet the very specific criteria and are willing to participate in a time-intensive clinical trial. Other studies and recruitment campaigns done throughout NIH have proven that BuildClinical is highly effective and efficient at identifying potential study participants, which will expedite the trial significantly, saving time and resources in the long term by shortening the time of the study and enabling us to enroll multiple participants simultaneously, and additionally this company has been granted government and NIH IT security approval, whereas other companies are not pre-approved. This study is also of value to the US Government so faster, more representative patient recruitment will enable NIH to make scientific discoveries more quickly.

The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement. All required documents must be submitted via the NIAID electronic Simplified Acquisition Submission System (eSASS) website at https://esass.nih.gov by January 3, 2025 at 5:00 pm ET. All vendors must register in the eSASS system to submit their documentation. Instructions on how to register /submit documents are included on the website. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.