Autoimmune Rheumatologic DiseaseNCT02917577
Hepatitis A Vaccine Dosing Regimens Among Pediatric Patients on Immunosuppressive Therapy
A study testing Avaxim Pediatric® and Avaxim ® (adult) in people with Autoimmune Rheumatologic Disease, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Autoimmune Rheumatologic Disease
- What is being tested?
- Avaxim Pediatric® and Avaxim ® (adult)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 22 Nov 2016to Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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:
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Alberta Children's Hospital/University of Calgary
Calgary, Alberta, T3B6A8
About this study
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
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.
Read the 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.
- Conditions
- Autoimmune Rheumatologic Disease
- Being tested
- Avaxim Pediatric®, Avaxim ® (adult)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avaxim Pediatric®Biological
2 doses (0.5 mL each) 6 months apart of Avaxim Pediatric® vaccine.
Avaxim ® (adult)Biological
2 doses (0.5 mL each) 6 months apart of Avaxim ® (adult) vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Avaxim Pediatric® | Active comparator | 2 doses (0.5 mL each) six months apart of Avaxim Pediatric® Receives: Biological: Avaxim Pediatric® |
| Avaxim ® (adult) | Active comparator | 2 doses (0.5 mL each) six months apart of Avaxim ® (adult) Receives: Biological: Avaxim ® (adult) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis A Antibodies Titre
Measured: 6 to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start22 Nov 2016
- Primary completionJun 2023
- Study completionJun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autoimmune Rheumatologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heinrike Schmeling, University of Calgary
- Investigators
- Heinrike Schmeling, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917577
- Sponsor's protocol ID
- HEP-2016
- Status last verified
- Jun 2024
- First submitted
- 26 Sep 2016
- Last updated
- 3 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02917577
- Acronym / sponsor ID
- HEP-2016
- Conditions
- Autoimmune Rheumatologic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- Jun 2023 (actual)
- Study completion
- Jun 2023 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Posted 3 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avaxim Pediatric® | Active comparator | Biological: Avaxim Pediatric®2 doses (0.5 mL each) six months apart of Avaxim Pediatric® |
| Avaxim ® (adult) | Active comparator | Biological: Avaxim ® (adult)2 doses (0.5 mL each) six months apart of Avaxim ® (adult) |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avaxim Pediatric®2 doses (0.5 mL each) 6 months apart of Avaxim Pediatric® vaccine. | Biological | Avaxim Pediatric® |
| Avaxim ® (adult)2 doses (0.5 mL each) 6 months apart of Avaxim ® (adult) vaccine. | Biological | Avaxim ® (adult) |
Primary outcome
Hepatitis A Antibodies Titre
Time frame: 6 to 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heinrike Schmeling, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avaxim Pediatric® and Avaxim ® (adult) in people with Autoimmune Rheumatologic Disease, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatitis A Antibodies Titre (time frame: 6 to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.