Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200
- Conditions
- Cholera
- Interventions
- Biological: PlaceboBiological: PXVX0200
- Registration Number
- NCT01585181
- Lead Sponsor
- Bavarian Nordic
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- Healthy Men or women, age 18 to 50 years (inclusive) without significant medical history, physical or clinical lab abnormalities (as per protocol defined ranges)
- Women of childbearing potential must have negative urine pregnancy test and must be willing to use adequate birth control for 2 months following vaccination and have additional pregnancy tests as indicated
- Vaccinees must live alone or have no more than two household contacts willing to sign informed consent and participate in the study
- Household contacts must be healthy (based on medical history) men or women aged 18-65 years (inclusive)
- Healthcare workers who have direct contact with patients who are immunodeficient, are HIV-positive, have unstable medical condition or are under the age of 18
- Childcare workers who have direct contact with children who are 2 years of age or younger or those employed in the food service industry
- Resides with HHCs who are under the age of 18 or over the age of 65
- Has abnormal stool pattern defined as fewer than 3 stools per week or more than 2 stools per day in past 6 months
- Has known allergy to, or known medical condition that precludes the use of both tetracycline or ciprofloxacin
- Previously received a licensed or investigational cholera vaccine
- Has history of cholera or enterotoxigenic E. coli infection (natural infection or experimental challenge)
- Travel to a cholera-endemic area and experienced symptoms consistent with traveler's diarrhea in the previous 5 years
- Received or plans to receive any other licensed vaccines from 14 days prior to the study vaccination until Day 28
- Received or plans to receive antibiotics (other than protocol-specified) or chloroquine within 14 days prior to the study vaccination through to Day 28
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - PXVX0200 PXVX0200 -
- Primary Outcome Measures
Name Time Method Safety Day 0-180 Safety defined as frequency and severity of vaccine-related reactogenicity events and reported AEs
Immunogenicity 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
- Secondary Outcome Measures
Name Time Method Serum anti-cholera toxin (CT) IgG antibody conversion rates Day 0-28 Anti-cholera toxin IgG antibody conversion rates
Kinetics Day 0-28 Kinetics of serum Inaba vibriocidal antibody after 1 oral dose of CVD 103-HgR
Vibriocidal seroconversion and shedding of CVD 103-HgR in household contacts Day 0-28 Vibriocidal seroconversion and shedding of CVD 103-HgR in household contacts
Fecal shedding Day 0-7 Fecal shedding of CVD 103-HgR by vaccine recipient
Trial Locations
- Locations (2)
University of Maryland
🇺🇸Baltimore, Maryland, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States