Brief Title
Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200
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 Cholerae Serotype 01 Inaba CVD 103-HgR Vaccine Strain
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Safety
Secondary Outcome
Kinetics
Condition
Cholera
Intervention
PXVX0200
Study Arms / Comparison Groups
Placebo
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
66
Start Date
April 2012
Completion Date
January 2013
Primary Completion Date
August 2012
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Gender
All
Ages
18 Years - 50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01585181
Organization ID
PXVX-VC-0200-002
Responsible Party
Sponsor
Study Sponsor
Emergent BioSolutions
Study Sponsor
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Verification Date
March 2020