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