Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200

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

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.

Study Overview

• Status: Completed
• Conditions: Cholera
• Intervention / Treatment: Biological: Placebo; Biological: PXVX0200

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0084
      • University of Kentucky
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Approx 2 grams of lactose reconstituted in water
Experimental: PXVX0200	Biological: PXVX0200; Single dose; liquid suspension after reconstitution with buffer; 2x108 to 2x109 CFU in a liquid suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Safety defined as frequency and severity of vaccine-related reactogenicity events and reported AEs	Day 0-180
Immunogenicity	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	Day 0-28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinetics	Kinetics of serum Inaba vibriocidal antibody after 1 oral dose of CVD 103-HgR	Day 0-28
Serum anti-cholera toxin (CT) IgG antibody conversion rates	Anti-cholera toxin IgG antibody conversion rates	Day 0-28
Fecal shedding	Fecal shedding of CVD 103-HgR by vaccine recipient	Day 0-7
Vibriocidal seroconversion and shedding of CVD 103-HgR in household contacts	Vibriocidal seroconversion and shedding of CVD 103-HgR in household contacts	Day 0-28

Collaborators and Investigators

• Sponsor: Bavarian Nordic
• Collaborators: Emergent BioSolutions

Publications and helpful links

General Publications

• 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.

Helpful Links

• PubMed (results)

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: April 23, 2012
• First Submitted That Met QC Criteria: April 24, 2012
• First Posted (Estimated): April 25, 2012

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Vaccine, Bacterial disease condition, Cholera
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vibrio Infections; Cholera
• Other Study ID Numbers: PXVX-VC-0200-002