Clinical trial NCT01585181: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cholera
Keywords: Vaccine, Bacterial disease condition, Cholera
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
Collaborators: name: Emergent BioSolutions
First posted: 2012-04-25
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Safety
timeFrame: Day 0-180
measure: Immunogenicity
timeFrame: Day 0-28
Secondary outcomes:
measure: Kinetics
timeFrame: Day 0-28
measure: Serum anti-cholera toxin (CT) IgG antibody conversion rates
timeFrame: Day 0-28
measure: Fecal shedding
timeFrame: Day 0-7
measure: Vibriocidal seroconversion and shedding of CVD 103-HgR in household contacts
timeFrame: Day 0-28
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
References:
citation: Chen WH, Greenberg RN, Pasetti MF, Livio S, Lock M, Gurwith M, Levine MM. Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR, prepared from new master and working cell banks. Clin Vaccine Immunol. 2014 Jan;21(1):66-73. doi: 10.1128/CVI.00601-13. Epub 2013 Oct 30.