A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults

June 26, 2023 updated by: Bavarian Nordic

A Phase III Randomized, Double-blind, Placebo-controlled Study in Older Adults to Assess Immunogenicity and Clinical Acceptability of a Single-dose of the Live Oral Cholera Vaccine Candidate PXVX0200 O1 Serotype Inaba Strain CVD 103-HgR

Demonstrate that the vaccine offers protection based on antibody levels in older adults and is similar to antibody levels in adults aged 18-45 following vaccination with PXVX0200.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Demonstrate that seroconversion by classical Inaba vibriocidal antibody at Day 11 in older adults ages 46-64 years (inclusive) was non inferior to seroconversion at Day 11 in younger adults ages 18-45 years following vaccination with PXVX0200.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
398

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research
    • Florida
      • DeLand, Florida, United States, 32720
        • Avail Clinical
      • Miami, Florida, United States, 33143
        • Miami Research Associates
      • Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Johnson County Clin-Trials
      • Wichita, Kansas, United States, 67207
        • Heartland Research
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02218
        • Boston University
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Center For Pharmaceutical Research
      • Saint Louis, Missouri, United States, 63104
        • St. Louis University
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research
    • Texas
      • Dallas, Texas, United States, 75234
        • Research Across America
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Jean Brown Research
    • Vermont
      • Burlington, Vermont, United States, 05405
        • University of Vermont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Able to understand the study and give written consent.
  2. Healthy male and female adults, age 46-64 years (inclusive) without significant medical history, physical, or abnormal screening laboratory test results at screening.
  3. Women of childbearing potential must have had a negative urine pregnancy test at screening, prior to vaccination. Female subjects must be of non-childbearing potential (as defined as surgically sterile or postmenopausal for more than 1 year), or if of childbearing potential must be practicing abstinence or using an effective licensed method of birth control (eg, use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, intrauterine devices [IUDs], cervical sponges, diaphragms, condoms with spermicidal agents; or must have a vasectomized partner) within 2 months of vaccination and must agree to continue such precautions during the study.
  4. Willing and able to comply with the study requirements and procedures.

Exclusion Criteria:

  1. Currently active unstable or undiagnosed medical conditions including immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurologic illness, psychiatric disorder requiring hospitalization, current drug or alcohol abuse. Examples of unstable or undiagnosed medical conditions including unstable angina pectoris, shortness of breath on exertion without clear etiology and chronic renal failure requiring dialysis. Examples of conditions that do not meet exclusion criteria include mild controlled hypertension, mild controlled asthma, and treated depression without hospitalization.
  2. Abnormal stool pattern defined as fewer than 3 stools per week or more than 2 stools per day in past 6 months.
  3. Regular use of laxatives in the past 6 months.
  4. Previously received a licensed or investigational cholera vaccine.
  5. History of cholera or enterotoxigenic E. coli infection (natural infection or experimental challenge).
  6. Travel to a cholera-endemic area in the previous 5 years.
  7. Received or plans to receive any other licensed vaccines, except for seasonal influenza vaccine, from 14 days prior to the study vaccination through to 29 days after vaccination.
  8. Received or plans to receive antibiotics or chloroquine within 14 days prior to the study vaccination through to 29 days after vaccination.
  9. Recipient of bone marrow or solid organ transplant.
  10. Use of systemic chemotherapy in the previous 5 years prior to the study.
  11. Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders diagnosed or treated during the past 5 years.
  12. Received or plans to receive systemic immunosuppressive therapy, radiation therapy, parenteral or high-dosage inhaled steroids (>800 µg/day of beclomethasone diproprionate or equivalent) within 6 months prior to the study vaccination through to Day 29.
  13. History of Guillain-Barré Syndrome.
  14. Pregnant or nursing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PXVX0200 in Older Adults
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension
Biological: PXVX0200
Placebo Comparator: Placebo in Older Adults
Placebo physiological saline
Biological: Placebo
Other: Historical Control: Adults Aged 18-45
This arm consists of historical data from subjects who received a single dose of PXVX0200 in study PXVX-VC-200-004. The data was included in study PXVX-VC-200-005 as a comparator bridging population for the Day 11 seroconversion. NCT02094586 PubMed ID:29317118
Biological: PXVX0200

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Seroconversion Rate at Day 11
Time Frame: Day 11
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
Day 11

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Geometric Mean Titer (GMT)
Time Frame: Day 11
The Day 11 vibriocidal GMTs were compared between older and younger adults.
Day 11

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumulative Seroconversion Through Day 29 Compared to Day 11 for Younger Adults
Time Frame: Day 29
The cumulative seroconversion through Day 29 for older adults was compared to the Day 11 seroconversion for the younger adults aged 18 - 45 yrs. Seroconversion is defined as a 4-fold rise in antibody titer relative to baseline values.
Day 29
Mean Fold Change in Vibriocidal Antibody Titer Between Day 1 and Day 11
Time Frame: Day 11
The mean log2 fold change between Day 1 and Day 11 in classical Inaba vibriocidal antibody titer attained by older adults was compared to the younger adults aged 18 - 45 yrs.
Day 11
Seroconversion Against Other V. Cholerae Biotypes/Serotypes
Time Frame: Day 11
Seroconversion of the vibriocidal antibody response against 4 V. cholerae biotypes/serotypes - classical Inaba, El Tor Inaba, classical Ogawa and El Tor Ogawa was assessed.
Day 11
Anti-CT Antibody Response in Older Adults
Time Frame: Day 11

The seroconversion of anti-Cholera Toxin (CT) antibody response in older adults was assessed.

Seroconversion is defined as a 4-fold rise in anti-CT antibody titer relative to baseline values.
Day 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bavarian Nordic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Emergent BioSolutions

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: James McCarty, MD, Emergent Travel Health Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PXVX-VC-200-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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