Cholera (Disorder) Clinical Trial
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
| Verified date | June 2023 |
| Source | Bavarian Nordic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 550 |
| Est. completion date | March 6, 2020 |
| Est. primary completion date | September 10, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 2 Years to 17 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Emory University | Atlanta | Georgia |
| United States | Boston Medical Center | Boston | Massachusetts |
| United States | Aventiv Research Inc. | Columbus | Ohio |
| United States | The Center for Pharmaceutical Research | Kansas City | Missouri |
| United States | Johnson County Clin-Trials, Inc. | Lenexa | Kansas |
| United States | University of Kentucky | Lexington | Kentucky |
| United States | Coastal Carolina Research Center | Mount Pleasant | South Carolina |
| United States | Clinical Research Associates, Inc. | Nashville | Tennessee |
| United States | Rochester Clinical Research, Inc. | Rochester | New York |
| United States | Heartland Research Associates, LLC | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Bavarian Nordic | Emergent BioSolutions |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at 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 | Day 1 | |
| Other | Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at 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 | Day 91 | |
| Other | Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at 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 | Day 181 | |
| Other | Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at 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. | Day 365 | |
| Other | Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at 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. | Day 547 | |
| Other | Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at 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. | Day 730 | |
| Other | Safety - Solicited Adverse Events | 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 | Through Day 8 | |
| Other | Safety - Unsolicited Adverse Events | Evaluate the safety and tolerability of VAXCHORA by collecting unsolicited adverse events by age cohort and overall through Day 29 | Through Day 29 | |
| Other | Safety - Serious Adverse Events | Evaluate the safety and tolerability of VAXCHORA by collecting serious adverse events by age cohort and overall through Day 181 | Through Day 181 | |
| Other | Acceptability | Evaluate the acceptability of VAXCHORA using the percent of subjects in each age cohort able to complete the dosing according to protocol. | Day 1 | |
| Primary | Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae | 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 | Day 11 | |
| Primary | Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae | 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. | Day 11 | |
| Primary | Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae | 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. | Day 11 | |
| Primary | Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years | 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. | Day 11 | |
| Primary | Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years | 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. | Day 11 | |
| Primary | Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years | 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. | Day 11 | |
| Secondary | Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects | Day 29 | |
| Secondary | Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 91 for all subjects | Day 91 | |
| Secondary | Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 181 for all subjects | Day 181 | |
| Secondary | Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 365 for all subjects | Day 365 | |
| Secondary | Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 547 for all subjects | Day 547 | |
| Secondary | Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 730 for all subjects | Day 730 | |
| Secondary | Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects | Day 29 | |
| Secondary | Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects | Day 29 |