Next Gen Vaccinations: Phase 2b Clinical Trial Execution

Next Gen Vaccinations: Phase 2b Clinical Trial Execution

The Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response, US Department of Health and Human Services has made the below awards for projects for the advanced clinical development and assessment of next-generation vaccines and therapeutics for COVID-19. BARDA has previously identified a capability gap for COVID-19 vaccines that, when compared to current vaccines, offer improved durability, breadth of protection, and/or transmission blocking in the face of new SARS-CoV-2 variants. Through these awards, BARDA will partner with developers and other organizations to advance the clinical development of next-generation COVID-19 vaccines into a Phase 2b clinical trial to include planning and regulatory support as needed. The goal of this project is to provide better COVID-19 solutions and bolster preparedness and response against future health security threats.

Award Details

Member Organization: CastleVax, Inc.
Award Date: 06/03/2024
Award Amount: $33,793,676.00
Project Duration: 47 Months

Solicitation Number: RRPV RPP-24-04-NGVx
Project Title: Efficacy of a Next-generation, Mucosally-delivered, NDV-vectored COVID-19 Booster Vaccine

Project Objective: The objective of this project is to coordinate with BARDA’s Clinical Services Network (CSN) to conduct a Phase 2b study comparing the efficacy, safety, and immunogenicity of CastleVax’s next-generation COVID-19 vaccine candidate with a currently licensed COVID-19 vaccine.

Member Organization: CyanVac, LLC
Award Date: 06/04/2024
Award Amount: $40,167,897.00
Project Duration: 31 Months

Solicitation Number: RRPV RPP-24-04-NGVx
Project Title: Phase 2B Clinical Trial Execution of NextGen PIV5-Vectored Intranasal COVID-19 Vaccine Track 2

Project Objective: The purpose of this project is for CyanVac to partner with BARDA and other organizations to advance the clinical development of next-generation COVID-19 vaccines into a Phase 2B clinical trial to include planning and regulatory support and vaccine manufacture. The Phase 2B study will determine efficacy of  intranasal vaccine in adults of >18-years of age in comparison to an active comparator of FDA-approved SARS-CoV-2 mRNA vaccine.  BARDA’s Clinical Studies Network (CSN) [will] conduct the Phase 2B study and CyanVac would provide manufacturing and regulatory support and collaborate with the CSN, for clinical, sample collection/storage and analyses activities.

Member Organization: GeoVax, Inc.
Award Date: 06/12/2024
Award Amount: $24,321,841.00
Project Duration: 42 Months

Solicitation Number: RRPV RPP-24-04-NGVx
Project Title: Phase 2b study to evaluate GEO-CM04S1 COVID-19 Vaccine

Project Objective: The overarching goal of the outlined work is to demonstrate the efficacy of the GeoVax  vaccine as a heterologous Coronavirus Disease 2019 (COVID-19) vaccine candidate, compared to that of a Food and Drug Administration (FDA) approved and commercially available COVID-19 vaccine. GeoVax plans to accomplish this through a Phase 2b randomized, double- blind, active-controlled study to evaluate clinical efficacy, immunogenicity, and safety. Individuals recruited for this clinical study will be highly diverse with respect to age, ethnicity and comorbidities, reflecting both healthy adults and populations at risk for serious or fatal disease associated with SARS-CoV-2 infections.

Member Organization: Vaxart, Inc.
Award Date: 06/13/2024
Award Amount: $452,884,477.00
Project Duration: 38 Months

Solicitation Number: RRPV RPP-24-04-NGVx
Project Title: Oral Mucosal Vaccine for SARS-CoV2 Protection

Project Objective: The objective of this project is to complete a phase 2b clinical trial, comparing Vaxart’s  candidate vaccine  to an approved mRNA COVID-19 vaccine. Vaxart has divided the program into two phases. Phase 1 includes the execution of a Phase 2b clinical trial comparing Vaxart’s vaccine candidate and an mRNA vaccine comparator for efficacy, immune induction, and safety. Phase 2 includes further analysis to characterize the durability of the immune responses initially characterized by tracking mucosal samples from vaccinated individuals for a year, and assessing cross-reactivity over time.