Phase 3 N=197 Randomized Quadruple-blind Prevention

Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera

Cholera

Bottom Line

View on ClinicalTrials.gov: NCT01895855 ↗

Enrolled (actual)

197

Serious AEs

1.0%

Results posted

Apr 2021

Primary outcome: Primary: % of Participants With Moderate to Severe Diarrhea — 5.7; 59.1 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: PXVX0200 (Biological); placebo (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Bavarian Nordic
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY % of Participants With Moderate to Severe Diarrhea	12.1; 59.1	—
PRIMARY % of Participants With Moderate to Severe Diarrhea	12.1; 59.1	—
SECONDARY Total Weight of Diarrheal Stools Following the 10 Day Cholera Challenge	309; 4524	0.0073 sig
SECONDARY Total Weight of Diarrheal Stools Following the 90 Day Cholera Challenge	603; 4524	<0.0001 sig
SECONDARY % of Participants With Diarrhea of Any Severity Following a 10 Day Cholera Challenge	14.3; 92.4	—
SECONDARY % of Participants With Diarrhea of Any Severity Following a 90 Day Challenge	45.5; 92.4	—
SECONDARY % of Participants With Fever Following the 10 Day Cholera Challenge	2.9; 27.3	0.0025 sig
SECONDARY % of Participants With Fever Following the 90 Day Cholera Challenge	6.1; 27.3	0.0159 sig
SECONDARY Number of Days With Fecal Shedding Following 10 Day Challenge	0.0; 3.0	<0.0001 sig
SECONDARY Number of Days With Fecal Shedding Following 90 Day Challenge	2.0; 3.0	<0.0001 sig
SECONDARY # of Days With Positive Stool Culture Following 10 Day Cholera Challenge	0.9; 3.3	<0.0001 sig
SECONDARY # of Days With Positive Stool Culture Following 90 Day Cholera Challenge	2.1; 3.3	<0.0001 sig
SECONDARY % of Participants With Reactogenicity, Diarrhea, Fever or Unsolicited Adverse Events Following Vaccination	49.5; 50.0; 1.1; 3.0; 2.2; 1.0	—

Summary

The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection

Eligibility Criteria

Inclusion Criteria

healthy men or women,
age 18 to 45 years inclusive;
normal medical history and physical examination; and
no clinically significant abnormalities from:
urine dipstick for glucose, protein, and blood
complete blood count,
serum hepatic transaminases,
total bilirubin (direct if abnormal),
creatinine,
electrolytes,
albumin, or
electrocardiogram.
Women must have a negative pregnancy test.

Exclusion Criteria

travel to a cholera endemic area in the previous 5 years;
abnormal stool pattern or regular use of laxatives;
history of eating disorders (such as bulimia), anal or rectal disorders, allergy to tetracycline and/or ciprofloxacin;
history of cholera or enterotoxigenic E. coli challenge or infection;
current or recent antibiotic use;
pregnancy or nursing;
positive serology for HIV, hepatitis B antigen, or hepatitis C;
any immunosuppressive medical condition;
history of hospitalization for psychiatric illness or use of specific psychiatric drugs.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01895855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.