Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200

Bavarian Nordic

Status and phase

Completed

Phase 1

Conditions

Cholera

Treatments

Biological: PXVX0200

Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01585181

PXVX-VC-0200-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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