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Hepatitis A Vaccine Dosing Regimens Among Pediatric Patients on Immunosuppressive Therapy

Primary Purpose

Autoimmune Rheumatologic Disease

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Avaxim Pediatric®

Avaxim ® (adult)

About this trial

This is an interventional prevention trial for Autoimmune Rheumatologic Disease

Eligibility Criteria

12 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent provided for the subject by a parent or legal guardian.
Written informed assent from the participants themselves.
Subjects whose parents the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, record safety observations, able to converse with study personnel and contactable by telephone).
Age 12 years to 15 years and 5 months
Confirmed chronic rheumatologic condition
Maintained on any immunosuppressive medication with the exception of pulse steroids

Exclusion Criteria:

Systemic hypersensitivity to any Hepatitis A vaccine component such as neomycin, 2-phenoxyethanol, formaldehyde, aluminum hydroxide, Medium 199 Hanks, or Polysorbate 80.
Thrombocytopenia or any bleeding disorder that contraindicates IM injection or blood collection.
Receipt of blood or any blood-derived products (including IVIG) within the past 3 months.
Previous laboratory-confirmed infection with Hepatitis A
Previous vaccination with any Hepatitis A vaccine

The following conditions are temporary or self-limiting exclusions so a subject can be vaccinated once the condition has resolved and no other exclusion criteria exist:

Current febrile illness or oral temperature of ≥ 38.5 °C (or equivalent by other route) or other moderate to severe illness within 24 hours before study vaccine administration
Receipt of any Hepatitis B vaccine within 28 days of planned study vaccine doses. When Twinrix® has been studied, the response to Hepatitis B is amplified by the presence of Hepatitis A. It is unknown whether the reverse is also true.
Routine childhood vaccines (except MMR and Varicella) must be separated from a study vaccination by at least 7 days.

Sites / Locations

Alberta Children's Hospital/University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Avaxim Pediatric®

Avaxim ® (adult)

Arm Description

2 doses (0.5 mL each) six months apart of Avaxim Pediatric®

2 doses (0.5 mL each) six months apart of Avaxim ® (adult)

Outcomes

Primary Outcome Measures

Hepatitis A antibodies titre

Secondary Outcome Measures

Full Information

NCT ID

NCT02917577

First Posted

September 26, 2016

Last Updated

July 10, 2023

Sponsor

University of Calgary

1. Study Identification

Unique Protocol Identification Number

NCT02917577

Brief Title

Hepatitis A Vaccine Dosing Regimens Among Pediatric Patients on Immunosuppressive Therapy

Official Title

A Randomized Controlled Trial of Two Hepatitis A Vaccine Doses Among Adolescents With Juvenile Idiopathic Arthritis and Crohn's Disease on Immunosuppressive Therapy: A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

November 22, 2016 (Actual)

Primary Completion Date

June 2023 (Actual)

Study Completion Date

June 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Calgary

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study is a prospective, single centre, double-blinded randomized controlled trial whose goal is to compare the immune response of a population of immunosuppressed pediatric rheumatology patients on immunosuppressive medications to two different doses of Hepatitis A vaccine. The objectives are (a) to confirm that adolescents, like their adult counterparts, have a reduced immune response to hepatitis A vaccine, and (b) to compare the immunogenicity of two different dosing options of vaccine for this age group after one and two doses. A total of 60 adolescents aged 12 - 15 years with confirmed chronic rheumatologic conditions for which they are being treated with an immunosuppressive therapy will be recruited from the Rheumatology Clinic at Alberta Children's Hospital (ACH). Those found to have no immunity to hepatitis A will be enrolled. Informed, written consent will be obtained from the parent or guardian of subject, with assent obtained from the study subjects. Subjects will be randomly assigned to two doses of either Avaxim Pediatric® or Avaxim ® (adult) vaccine (Sanofi Pasteur Canada), six months apart, with hepatitis A titres done at baseline and one month after each dose. Both formulations are licensed for this age group.

Detailed Description

This is a prospective, single centre, randomized, controlled trial comparing immune responses to two doses of a licensed Hepatitis A vaccine in children. Subjects will receive 2 doses (0.5 mL each) of the assigned study vaccine (Avaxim Pediatric® or Avaxim ® (adult) vaccine). One lot of each vaccine formulation will be studied. All subjects will provide safety observations using a diary and sequential blood samples will be obtained to measure serologic/immunologic responses. The study population will include 60 subjects with confirmed rheumatologic condition on immunosuppressive medication, males and females, in the age range 12 - 15 years. The maximum age at enrollment is 15 years and 5 months, to allow for up to 7 months in which to complete 2 doses of vaccine before age 16 years.Both vaccine formulations used in this trial has been licensed for use in Canada in the age range of the subjects being studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autoimmune Rheumatologic Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Avaxim Pediatric®

Arm Type

Active Comparator

Arm Description

2 doses (0.5 mL each) six months apart of Avaxim Pediatric®

Arm Title

Avaxim ® (adult)

Arm Type

Active Comparator

Arm Description

2 doses (0.5 mL each) six months apart of Avaxim ® (adult)

Intervention Type

Biological

Intervention Name(s)

Avaxim Pediatric®

Intervention Description

2 doses (0.5 mL each) 6 months apart of Avaxim Pediatric® vaccine.

Intervention Type

Biological

Intervention Name(s)

Avaxim ® (adult)

Intervention Description

2 doses (0.5 mL each) 6 months apart of Avaxim ® (adult) vaccine.

Primary Outcome Measure Information:

Title

Hepatitis A antibodies titre

Time Frame

6 to 7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent provided for the subject by a parent or legal guardian. Written informed assent from the participants themselves. Subjects whose parents the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, record safety observations, able to converse with study personnel and contactable by telephone). Age 12 years to 15 years and 5 months Confirmed chronic rheumatologic condition Maintained on any immunosuppressive medication with the exception of pulse steroids Exclusion Criteria: Systemic hypersensitivity to any Hepatitis A vaccine component such as neomycin, 2-phenoxyethanol, formaldehyde, aluminum hydroxide, Medium 199 Hanks, or Polysorbate 80. Thrombocytopenia or any bleeding disorder that contraindicates IM injection or blood collection. Receipt of blood or any blood-derived products (including IVIG) within the past 3 months. Previous laboratory-confirmed infection with Hepatitis A Previous vaccination with any Hepatitis A vaccine The following conditions are temporary or self-limiting exclusions so a subject can be vaccinated once the condition has resolved and no other exclusion criteria exist: Current febrile illness or oral temperature of ≥ 38.5 °C (or equivalent by other route) or other moderate to severe illness within 24 hours before study vaccine administration Receipt of any Hepatitis B vaccine within 28 days of planned study vaccine doses. When Twinrix® has been studied, the response to Hepatitis B is amplified by the presence of Hepatitis A. It is unknown whether the reverse is also true. Routine childhood vaccines (except MMR and Varicella) must be separated from a study vaccination by at least 7 days.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heinrike Schmeling, MD

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alberta Children's Hospital/University of Calgary

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T3B6A8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Hepatitis A Vaccine Dosing Regimens Among Pediatric Patients on Immunosuppressive Therapy

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