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

Phase 3CompletedNCT02094586

Bavarian Nordic3,146 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

3,146

Conditions

Cholera

Interventions

PXVX0200 Lot ABIOLOGICAL

Lot P700-1CA03

PXVX0200 Lot BBIOLOGICAL

Lot P700-3CA03

PXVX0200 Lot CBIOLOGICAL

Lot P700-6BA03

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (25)

Coastal Clinical Research

Mobile, Alabama, United States

Outcomes

Primary Outcomes

Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B

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.

Time frame: Day 11

Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C

Time frame: Day 11

Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

SVA Seroconversion at Day 11

Percentage of subjects who demonstrated a ≥4-fold rise over baseline in serum vibriocidal antibody (SVA) at Day 11

Time frame: Day 11

SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181

GMTs of vibriocidal antibody and anti-CT IgG concentrations at Days 1, 11, 29, 91, and 181.

Time frame: Day 1 - 181

SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 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.

Time frame: Day 1 - 181

Adverse Events

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.

Time frame: Day 1 - 29