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VAXCHORA Pediatric Study to Assess Safety and Immunogenicity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03220737
Recruitment Status : Completed
First Posted : July 18, 2017
Results First Posted : November 19, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Emergent BioSolutions

Brief Summary:
VAXCHORA (Cholera Vaccine, Live, Oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. VAXCHORA is approved for use in adults 18 through 64 years of age travelling to cholera-affected areas. The primary goals of this Phase 4 study are to evaluate the safety and immunogenicity of a single dose of VAXCHORA (1 x 10e9 cfu/dose) in children ages 2 years to <18 years of age in developed countries.

Condition or disease Intervention/treatment Phase
Cholera (Disorder) Biological: VAXCHORA (Cholera Vaccine, Live, Oral) Other: Placebo Phase 4

Detailed Description:
This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.

The main study consists of a screening period of 30 days, a treatment period from Day 1 to Day 29, and a follow-up period through Day 181. Cohort 1 has an optional sub-study consisting of a long-term follow-up period through Day 730.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The study will be conducted as a double-blind study through 181, where neither the sponsor, the statistical team, study volunteer subjects, nor clinical site personnel (except for the unblinded administration staff) will know subjects' treatment assignment. Once each subject has reached their Day 181 visit they will be individually unblinded.
Primary Purpose: Prevention
Official Title: A Phase 4 Study to Assess the Safety and Immunogenicity of VAXCHORA (Cholera Vaccine, Live, Oral) in Children 2 to <18 Years of Age
Actual Study Start Date : July 21, 2017
Actual Primary Completion Date : September 10, 2019
Actual Study Completion Date : March 6, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholera Vaccines

Arm Intervention/treatment
Experimental: Cohort 1 (active, 12-17 yrs)
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
Biological: VAXCHORA (Cholera Vaccine, Live, Oral)
VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.

Placebo Comparator: Cohort 1 (placebo, 12 - 17 yrs)
Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Other: Placebo
Placebo control for this study is normal (0.9%) saline.

Experimental: Cohort 2 (active, 6 - 11 yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
Biological: VAXCHORA (Cholera Vaccine, Live, Oral)
VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.

Placebo Comparator: Cohort 2 (placebo, 6 - 11 yrs)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Other: Placebo
Placebo control for this study is normal (0.9%) saline.

Experimental: Cohort 3 (active, 2 - 5 yrs)
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
Biological: VAXCHORA (Cholera Vaccine, Live, Oral)
VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.

Placebo Comparator: Cohort 3 (placebo, 2 - 5 yrs)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Other: Placebo
Placebo control for this study is normal (0.9%) saline.

Historical Control: Adult Bridging Population
This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-006 as a comparator bridging population for the Day 11 seroconversion. NCT02094586 PubMed ID:29317118
Biological: VAXCHORA (Cholera Vaccine, Live, Oral)
VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.




Primary Outcome Measures :
  1. Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae [ Time Frame: Day 11 ]
    The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer

  2. Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae [ Time Frame: Day 11 ]
    The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer.

  3. Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae [ Time Frame: Day 11 ]
    The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer.

  4. Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years [ 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 pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.

  5. Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years [ 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 pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.

  6. Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years [ 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 pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of18 and 45 years.


Secondary Outcome Measures :
  1. Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29 [ Time Frame: Day 29 ]
    Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects

  2. Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91 [ Time Frame: Day 91 ]
    Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 91 for all subjects

  3. Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181 [ Time Frame: Day 181 ]
    Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 181 for all subjects

  4. Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365 [ Time Frame: Day 365 ]
    Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 365 for all subjects

  5. Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547 [ Time Frame: Day 547 ]
    Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 547 for all subjects

  6. Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730 [ Time Frame: Day 730 ]
    Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 730 for all subjects

  7. Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29 [ Time Frame: Day 29 ]
    Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects

  8. Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29 [ Time Frame: Day 29 ]
    Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects


Other Outcome Measures:
  1. Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 1 [ Time Frame: Day 1 ]
    Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 1 for the subjects in the active treatment group and the placebo crossover group

  2. Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 91 [ Time Frame: Day 91 ]
    Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 91 for the subjects in the active treatment group and the placebo crossover group

  3. Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 181 [ Time Frame: Day 181 ]
    Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 181 for the subjects in the active treatment group and the placebo crossover group

  4. Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 365 [ Time Frame: Day 365 ]
    Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 365 for the subjects in the active treatment group who participate in the substudy.

  5. Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 547 [ Time Frame: Day 547 ]
    Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 547 for the subjects in the active treatment group who participate in the substudy.

  6. Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 730 [ Time Frame: Day 730 ]
    Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 730 for the subjects in the active treatment group who participate in the substudy.

  7. Safety - Solicited Adverse Events [ Time Frame: Through Day 8 ]
    Evaluate the safety and tolerability of VAXCHORA by collecting solicited adverse events (abdominal pain, headache, lack of appetite, tiredness, diarrhea, nausea, vomiting and fever) by age cohort and overall through Day 8

  8. Safety - Unsolicited Adverse Events [ Time Frame: Through Day 29 ]
    Evaluate the safety and tolerability of VAXCHORA by collecting unsolicited adverse events by age cohort and overall through Day 29

  9. Safety - Serious Adverse Events [ Time Frame: Through Day 181 ]
    Evaluate the safety and tolerability of VAXCHORA by collecting serious adverse events by age cohort and overall through Day 181

  10. Acceptability [ Time Frame: Day 1 ]
    Evaluate the acceptability of VAXCHORA using the percent of subjects in each age cohort able to complete the dosing according to protocol.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or Female
  • Between 2 and <18 years of age on Day 1
  • In general good health
  • Able and willing to provide informed assent for study participation
  • Primary caregiver is able and willing to provide informed consent for study participation
  • (for females of childbearing potential) Using an acceptable method of contraception through Day 29

Exclusion Criteria:

  • Current acute gastrointestinal illness or loose stools within 3 days of Day 1 visit
  • Current acute febrile illness
  • History of cholera infection
  • History of cholera vaccination
  • History of severe allergic reaction (e.g. anaphylaxis) to any ingredient of VAXCHORA
  • Congenital or acquired immunodeficiency
  • Pregnancy (for females of childbearing potential)
  • Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject
  • Any other condition that, in the opinion of the Investigator, will interfere with the conduct of the study or the validity of the data
  • Duration of >2 weeks of abnormal stool pattern, defined as <3 stools per week or >2 stools per day in the past 6 months
  • Regular use of laxatives in the past 6 months
  • History of enterotoxigenic E. coli infection
  • Travel to cholera-endemic area in the previous 5 years
  • Nursing/Breastfeeding
  • Received or plans to receive the following from 14 days prior to the study vaccination through 11 days after vaccination: Any other licensed vaccines, antibiotics, or chloroquine
  • Received or plans to receive any other investigational agent throughout the main study (Day 181)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220737


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Kansas
Johnson County Clin-Trials, Inc.
Lenexa, Kansas, United States, 66219
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, New York
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
United States, Ohio
Aventiv Research Inc.
Columbus, Ohio, United States, 43123
United States, South Carolina
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Clinical Research Associates, Inc.
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Emergent BioSolutions
Investigators
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Study Director: Paul Andre de Lame, MD Emergent BioSolutions
  Study Documents (Full-Text)

Documents provided by Emergent BioSolutions:
Study Protocol  [PDF] November 15, 2017
Statistical Analysis Plan  [PDF] November 28, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT03220737    
Other Study ID Numbers: PXVX-VC-200-006
First Posted: July 18, 2017    Key Record Dates
Results First Posted: November 19, 2020
Last Update Posted: December 24, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholera
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections