Vaccine Response ImpairedPhase 2NCT01446978
Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs
A Phase 2 study testing hepatitis A vaccine in people with Vaccine Response Impaired, run by Sormland County Council, Sweden at 4 sites in Sweden.
Trial summary
Hepatitis A vaccine is the most frequently used traveler's vaccine, yet data on its ability to induce protective immunity in immunosuppressed travelers are scarce. The investigators assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis (RA) treated with Tumor Necrosis Factor (TNF)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaccine Response Impaired
- What is being tested?
- hepatitis A vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesSweden
- Study dates
- Sep 2011to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of rheumatoid arthritis
- TNF-alfa blocker and / or methotrexate in use as a medication against RA
- A desire to get protected against hepatitis A
- Men and women age 18-65 years
- Written informed consent
- Women of childbearing potential must use effective contraception -
Who cannot join
- Treatment with rituximab within 9 months before study start
- Known previous hepatitis A infection
- Previous vaccination against hepatitis A
- Allergy to eggs or formaldehyde
- Pregnancy or lactation
- Excessive use of alcohol
Show all 16Show fewer
- Mental retardation
- Acute disease at the time of examination (fever > 38 degrees)
- Volunteer works as an employee of the researchers
- Previous vaccination against hepatitis A
- Egg-, hen-protein- or formaldehyde allergy
- Pregnancy or lactation
- Excessive use of alcohol
- Another vaccine given within a month
- Acute disease at the time of examination (fever > 38 degrees)
- Not suitable for other reason in the investigator's opinion (other serious disease, i.e. AIDS/HIV-positive, cancer with ongoing cytostatic treatment)
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Dept infectious diseases
Eskilstuna, 631 88
Dept infectious diseases
Örebro, 70185
Department of infectious diseases
Stockholm, 17176
Dept infectious diseases
Uppsala, 75185
About this study
Official title: Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate
Hepatitis A vaccine is the most frequently used traveler's vaccine, yet data on its ability to induce protective immunity in immunosuppressed travelers are scarce. The investigators assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis (RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx).
In a previous study, 2 doses were not considered effective and there is therefore need for a study with an additional dose
Read the detailed description
Methods: Parameters registered at baseline were: age, sex, duration of disease, medications, activity of disease (Visual Analogue Scale), Health Assessment Questionnaire Disability Index, Disease Activity Score, Acute phase reactant and total immunoglobulin G in plasma). Hepatitis A vaccine (Epaxal or Havrix) were given at 0 and 6 months. Hepatitis A virus (HAV) antibodies is measured before vaccination and at month 1, 6 (before dose 2), 7 and 12 with quantitative HAV IgG, using the HAVAb-IgG Architect System, and by the HAVAB 2.0 assay on the AxSYM machine from Abbott. The level of protective immunity to HAV is defined as HAV IgG > 10mIU/mL.
- Conditions
- Vaccine Response Impaired
- Being tested
- hepatitis A vaccine
- Keywords
- hepatitis A vaccine, TNF-alfa inhibitory drugs, Rheumatoid arthritis, methotrexate
- Medical subject headings
- Hepatitis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatitis A vaccineBiological
3 doses of hepatitis A vaccine, given at 0+1+6 months
hepatitis A vaccineBiological
Two doses of hepatitis A vaccine given at day 0, one in each M deltoids. An additional dose will be given at 6 months later
| Study group | Role | What they receive |
|---|---|---|
| initial single dose of hep A vaccine | Active comparator | The participants will receive a single dose of hepatitis A vaccine at 0+1+6 months Receives: Biological: hepatitis A vaccine |
| initial double dose | Active comparator | Participants will receive one dose of hepatitis A vaccine in each M. deltoids and an additional dose at 6 months later Receives: Biological: hepatitis A vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroconversion after the first dose/doses of hepatitis A vaccine
ELISA-titers are determined before the first dose/doses and at 1 month later
Measured: one month after the first dose/doses
Secondary outcomes (1)
seroconversion rates after three doses of hepatitis A vaccine
We determine seroconversion rates before the third vaccine dose (6 months after the first) and at 1 and 6 months after the second dose
Measured: 12 months after the first doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Response ImpairedStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sormland County Council, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Rombo, Sormland County Council, Sweden
- Investigators
- lars rombo, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446978
- Sponsor's protocol ID
- Rombo - 2
- Status last verified
- Nov 2015
- First submitted
- 3 Oct 2011
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate
- ClinicalTrials.gov ID
- NCT01446978
- Acronym / sponsor ID
- Rombo - 2
- Conditions
- Vaccine Response Impaired
- Keywords
- hepatitis A vaccine, TNF-alfa inhibitory drugs, Rheumatoid arthritis, methotrexate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sormland County Council, SwedenUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatitis A vaccine is the most frequently used traveler's vaccine, yet data on its ability to induce protective immunity in immunosuppressed travelers are scarce. The investigators assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis (RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx).
In a previous study, 2 doses were not considered effective and there is therefore need for a study with an additional dose
Detailed description
Methods: Parameters registered at baseline were: age, sex, duration of disease, medications, activity of disease (Visual Analogue Scale), Health Assessment Questionnaire Disability Index, Disease Activity Score, Acute phase reactant and total immunoglobulin G in plasma). Hepatitis A vaccine (Epaxal or Havrix) were given at 0 and 6 months. Hepatitis A virus (HAV) antibodies is measured before vaccination and at month 1, 6 (before dose 2), 7 and 12 with quantitative HAV IgG, using the HAVAb-IgG Architect System, and by the HAVAB 2.0 assay on the AxSYM machine from Abbott. The level of protective immunity to HAV is defined as HAV IgG > 10mIU/mL.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| initial single dose of hep A vaccine | Active comparator | Biological: hepatitis A vaccineThe participants will receive a single dose of hepatitis A vaccine at 0+1+6 months |
| initial double dose | Active comparator | Biological: hepatitis A vaccineParticipants will receive one dose of hepatitis A vaccine in each M. deltoids and an additional dose at 6 months later |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of rheumatoid arthritis
- TNF-alfa blocker and / or methotrexate in use as a medication against RA
- A desire to get protected against hepatitis A
- Men and women age 18-65 years
- Written informed consent
Key exclusion criteria (16 listed)
- Treatment with rituximab within 9 months before study start
- Known previous hepatitis A infection
- Previous vaccination against hepatitis A
- Allergy to eggs or formaldehyde
- Pregnancy or lactation
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 |
|---|---|---|
| hepatitis A vaccine3 doses of hepatitis A vaccine, given at 0+1+6 months | Biological | initial single dose of hep A vaccine |
| hepatitis A vaccineTwo doses of hepatitis A vaccine given at day 0, one in each M deltoids. An additional dose will be given at 6 months later | Biological | initial double dose |
Primary outcome
seroconversion after the first dose/doses of hepatitis A vaccine
Time frame: one month after the first dose/doses
ELISA-titers are determined before the first dose/doses and at 1 month later
1 secondary outcome
seroconversion rates after three doses of hepatitis A vaccine
Time frame: 12 months after the first doses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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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.
lars rombo, MD principal investigator
Karolinska Institutet
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hepatitis A vaccine in people with Vaccine Response Impaired, run by Sormland County Council, Sweden at 4 sites in Sweden.
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 16 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: status not confirmed, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
seroconversion after the first dose/doses of hepatitis A vaccine (time frame: one month after the first dose/doses). 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 18 Nov 2015.