Close Menu
    Facebook X (Twitter) Instagram
    Facebook Instagram Threads
    Global BiodefenseGlobal Biodefense
    Subscribe
    • Featured News
    • Funding
    • Directory
    • Jobs
    • Events
    Global BiodefenseGlobal Biodefense
    Industry News

    Successful Phase III Cholera Vaccine Trial

    By Global Biodefense StaffDecember 9, 2014
    Biodefense Vaccine Development
    Credit: Shutterstock, modified by Global Biodefense
    Share
    Facebook LinkedIn Reddit Email

    PaxVax Inc., a specialty vaccine company focused on travel and biodefense, this week announced positive results from a Phase 3 safety and lot-to-lot consistency trial of its single-dose oral cholera vaccine candidate, PXVX0200.

    The vaccine utilizes the same attenuated vaccine strain (CVD 103-HgR) previously approved and marketed in several countries under the brand name Orochol. PaxVax intends to submit a Biologics License Application (BLA) for this product, under the brand name Vaxchora, to the U.S. Food and Drug Administration (FDA) in mid-2015.

    The Phase 3 trial evaluated the immunogenicity and safety of three consecutive production lots of the PXVX0200 vaccine candidate. The three production lots induced immunological responses across the clinical trial subjects that met the pre-specified immunological endpoint for consistency of manufacture.

    The results of this trial are the last major clinical milestone prior to submission of market applications in the U.S., the European Union, Canada, and Australia.

    A vaccine for cholera is not currently available in the U.S. for residents who travel abroad to areas where cholera poses a risk, such as Haiti or Central Africa. A cholera vaccine is available in Europe and elsewhere for travelers, but it requires a two-dose regimen. If licensed, oral PXVX0200 would be the first single-dose vaccine against cholera making it more convenient for all travelers, particularly for those traveling on short notice.

    Source: PaxVax press release, adapted.

    Cholera Vaccine News
    Share. Facebook LinkedIn Reddit Email
    Previous ArticleHHS Backs 3 Ebola Vaccines with PREP Protections
    Next Article 2014 National Health Security Preparedness Index

    Related Stories

    Inflammatix Completes Development for Acute Infection and Sepsis Test System

    November 15, 2023

    NanoViricides’ Phase 1 Broad-Spectrum Antiviral Highly Effective for Mpox and Smallpox

    November 14, 2023

    COVID Moonshot Consortium Announces Crowd-Sourced Small Molecule Discovery

    November 11, 2023

    Call for Experts: Smallpox Medical Countermeasures

    October 28, 2023
    News Scan

    Biodefense Headlines – 30 November 2023

    News Scan November 30, 2023

    News highlights on health security threats and countermeasures curated by Global Biodefense This week’s selections include the largest ever outbreak of mpox in the DRC; launch of National Wastewater Surveillance Program dashboard; low uptake of COVID-19 boosters and flu vaccines;…

    Upcoming Events

    Mar 12
    Hybrid Hybrid Event
    March 12, 2024 - March 17, 2024

    2024 Fungal Genetics Conference

    Mar 21
    March 21, 2024 - March 23, 2024

    ASPPH 2024 Annual Meeting

    View Calendar

    Subscribe to Global Biodefense

    Get the latest news on pathogens and preparedness

    News on pathogens and preparedness for public health emergencies

    © 2023 Stemar Media Group LLC
    • About
    • Contact
    • Privacy
    • Subscribe

    Type above and press Enter to search. Press Esc to cancel.