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Completed

NCT Number: NCT03220737

VAXCHORA Pediatric Study to Assess Safety and Immunogenicity

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.

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Key information

Conditions

Cholera (Disorder) Bacterial Infections Bacterial Infections and Mycoses Cholera Gram-Negative Bacterial Infections Infections Vibrio Infections

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory University, Atlanta, Georgia, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

VAXCHORA (Cholera Vaccine, Live, Oral)

Biological

VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.

Placebo

Other

Placebo control for this study is normal (0.9%) saline.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bavarian Nordic

Industry

Collaborators

  • Emergent BioSolutions

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 18, 2017
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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