Hepatitis A Vaccine Dosing Regimens Among Pediatric Patients on Immunosuppressive Therapy

NCT02917577 | Completed Results

• 1 other identifier: HEP-2016
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Rheumatologic Disease

Outcome Measures

Primary Outcomes (1)

• Hepatitis A Antibodies Titre

  6 to 7 months

Study Arms (2)

Avaxim Pediatric®

ACTIVE COMPARATOR

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

Biological: Avaxim Pediatric®

Avaxim ® (adult)

ACTIVE COMPARATOR

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

Biological: Avaxim ® (adult)

Interventions

Avaxim Pediatric® BIOLOGICAL

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

Avaxim Pediatric®

Avaxim ® (adult) BIOLOGICAL

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

Avaxim ® (adult)

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Alberta Children's Hospital/University of Calgary

Calgary, Alberta, T3B6A8, Canada

Location

Results Point of Contact

• Title: Heinrike Schmeling
• Organization: UCalgary

schmelingresearch@albertahealthservices.ca

4039553194

Study Officials

• Heinrike Schmeling, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 28, 2016
• Study Start: November 22, 2016
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 3, 2024
• Results First Posted: October 3, 2024

Record last verified: 2024-06

Locations

CA (1)