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Completed

NCT Number: NCT02094586

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

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

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Key information

Conditions

Cholera Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Vibrio Infections

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

QIMR Berghofer Medical Research Institiue, Herston, Queensland, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PXVX0200 Lot A

Biological

Lot P700-1CA03

PXVX0200 Lot B

Biological

Lot P700-3CA03

PXVX0200 Lot C

Biological

Lot P700-6BA03

Placebo

Biological

Placebo

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. SVA Seroconversion at Day 11

    Time frame: Day 11

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

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

    Time frame: Day 1 - 181

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

  3. SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181

    Time frame: 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.

  4. Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bavarian Nordic

Industry

Collaborators

  • Emergent BioSolutions

Registry information

Official study title

Phase 3 Randomized, Double-blind, Placebo-Controlled 3-Lot Study in Healthy Volunteers to Assess Immunogenicity, & Acceptability of a Single-dose of Live Oral Cholera Vaccine, Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 24, 2014
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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