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A Phase 1 Randomized, Observer-Blind, Active- and Placebo-Controlled Dose Comparison, Safety, Tolerability and Immunogenicity Study of Intranasal Adjuvanted Anthrax Vaccine (BW-1010; rPA + 20%W805EC) in Healthy Adult Volunteers Administered by Nasal Sprayer and Pipette With an Additional Unblinded Positive Control Arm

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Trial Profile

A Phase 1 Randomized, Observer-Blind, Active- and Placebo-Controlled Dose Comparison, Safety, Tolerability and Immunogenicity Study of Intranasal Adjuvanted Anthrax Vaccine (BW-1010; rPA + 20%W805EC) in Healthy Adult Volunteers Administered by Nasal Sprayer and Pipette With an Additional Unblinded Positive Control Arm

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 20 May 2022

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At a glance

  • Drugs BW 1010 (Primary) ; Anthrax vaccine
  • Indications Anthrax
  • Focus Adverse reactions; First in man; Pharmacodynamics; Proof of concept
  • Acronyms IN NE-rPA
  • Sponsors BlueWillow Biologics

Most Recent Events

  • 11 May 2022 Status changed from active, no longer recruiting to completed.
  • 26 Oct 2021 According to a BlueWillow Biologics media release, data from this study will be presented at the Lightning Talks Session of BARDA's Industry Day, Nov 3 - 4 , 2021.
  • 24 Aug 2021 According to a BlueWillow Biologics media release, the trial was funded under contract HHSN272201600045C from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

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