NCT01585181

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cholera

Interventions

Type	Name	Description
BIOLOGICAL	PXVX0200	Single dose; liquid suspension after reconstitution with buffer; 2x108 to 2x109 CFU in a liquid suspension
BIOLOGICAL	Placebo	Approx 2 grams of lactose reconstituted in water

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-08-01
• Completion: 2013-01-01
• First posted: 2012-04-25
• Last updated: 2023-06-27

Locations

2 sites across 1 country: United States