Clinical Trial: Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1 Randomized, Double-Blind Placebo Controlled Study to Evaluate the Safety and Immunogenicity of the LIve Oral Cholera Vaccine Candidate PXVX0200 Vibrio

Brief Summary: The purpose of this study is to compare the safety and immunogenicity of a single dose of the PXVX0200 live cholera vaccine versus placebo in volunteers (Vaccinees) and whether PXVX0200, which is a live attenuated bacteria, can be transmitted to other adults living in the same household.

Detailed Summary: Approximately 60 subjects and up to 120 household contacts will be enrolled in the United States. Vaccinees will be randomly assigned to receive either PXVX0200 or placebo in a 5:1 ratio and will be followed for 180 days postdose.
Sponsor: PaxVax, Inc.

Current Primary Outcome:

  • Safety [ Time Frame: Day 0-180 ]
    Safety defined as frequency and severity of vaccine-related reactogenicity events and reported AEs
  • Immunogenicity [ Time Frame: Day 0-28 ]
    Immunogenicity as defined as rate of seroconversion (4-fold rise) of serum Inaba vibriocidal antibody and initial estimates of between subject variability of vibriocidal antibody response


Original Primary Outcome:

  • Safety defined as frequency and severity of vaccine-related reactogenicity events and reported AEs [ Time Frame: Day 0-180 ]
  • Immunogenicity defined as rate of seroconversion (4-fold rise) of serum Inaba vibriocidal antibody and initial estimates of between subject variability of vibriocidal antibody response [ Time Frame: Day 0-28 ]


Current Secondary Outcome:

  • Kinetics [ Time Frame: Day 0-28 ]
    Kinetics of serum Inaba vibriocidal antibody after 1 oral dose of CVD 103-HgR
  • Serum anti-cholera toxin (CT) IgG antibody conversion rates [ Time Frame: Day 0-28 ]
    Anti-cholera toxin IgG antibody conversion rates
  • Fecal shedding [ Time Frame: Day 0-7 ]
    Fecal shedding of CVD 103-HgR by vaccine recipient
  • Vibriocidal seroconversion and shedding of CVD 103-HgR in household contacts [ Time Frame: Day 0-28 ]
    Vibriocidal seroconversion and shedding of CVD 103-HgR in household contacts


Original Secondary Outcome:

  • Kinetics of serum Inaba vibriocidal antibody after 1 oral dose of CVD 103-HgR [ Time Frame: Day 0-28 ]
  • Serum anti-cholera toxin (CT) IgG antibody conversion rates [ Time Frame: Day 0-28 ]
  • Fecal shedding of CVD 103-HgR by vaccine recipient [ Time Frame: Day 0-7 ]
  • Vibriocidal seroconversion and shedding of CVD 103-HgR in household contacts [ Time Frame: Day 0-28 ]


Information By: PaxVax, Inc.

Dates:
Date Received: April 23, 2012
Date Started: April 2012
Date Completion:
Last Updated: March 12, 2015
Last Verified: March 2015