A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults

Phase 3

Completed

• Conditions: Cholera

• Registration Number: NCT02094586
• Lead Sponsor: Bavarian Nordic

Brief Summary

The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.

Detailed Description

The primary goal of this Phase III study is to compare three lots for consistency of manufacture.

Study Timeline

• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-24
• Study Start: 2014-05
• Primary Completion: 2015-02
• Study Completion: 2015-06
• Results First Submitted: 2018-07-03
• Results First Submitted QC: 2021-06-24
• Results First Posted: 2021-07-15
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-26
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3146

Inclusion Criteria

• healthy men or women,
• age 18 to 45 years inclusive;
• normal medical history and physical examination
• 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;
• Currently active unstable or undiagnosed medical conditions
• current or recent antibiotic use;
• pregnancy or nursing;
• Previously received a licensed or investigational cholera vaccine
• History of cholera or enterotoxigenic E. coli infection
• History of Guillain-Barré Syndrome
• Received or plans to receive any other licensed vaccines, except for seasonal influenza
• Recipient of bone marrow or solid organ transplant
• Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders diagnosed or treated during the past 5 years
• Use of systemic chemotherapy in the previous 5 years prior to the study
• any immunosuppressive medical condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B	Day 11	The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5. Placebo GMT values were not included in the primary analysis.
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C	Day 11	The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5.
Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C	Day 11	The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5.

Secondary Outcome Measures

Name	Time	Method
SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181	Day 1 - 181	GMTs of vibriocidal antibody and anti-CT IgG concentrations at Days 1, 11, 29, 91, and 181.
SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181	Day 1 - 181	Proportion of subjects who demonstrated a ≥4-fold rise over baseline in vibriocidal antibody and anti-CT IgG concentration from baseline at Days 1, 11, 29, 91, and 181. Day 1 not reported as seroconversion on Day 1 not applicable.
Adverse Events	Day 1 - 29	Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, fever \& vomiting were collected from Day 1 - 8.; Incidence and severity of unsolicited adverse events were collected till Day 29.
SVA Seroconversion at Day 11	Day 11	Percentage of subjects who demonstrated a ≥4-fold rise over baseline in serum vibriocidal antibody (SVA) at Day 11

Trial Locations

Locations (25)

Coastal Clinical Research; 🇺🇸 Mobile, Alabama, United States

Clinical Reseach Consortium Arizona; 🇺🇸 Phoenix, Arizona, United States

Avail Clinical Research; 🇺🇸 DeLand, Florida, United States

Miami Research Associates; 🇺🇸 Miami, Florida, United States

Palm Beach Research; 🇺🇸 West Palm Beach, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Johnson County Clin-Trials; 🇺🇸 Lenexa, Kansas, United States

Heartland Research Associates; 🇺🇸 Wichita, Kansas, United States

Central Kentucky Research; 🇺🇸 Lexington, Kentucky, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

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