Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs
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ClinicalTrials.gov Identifier: NCT01446978 |
Recruitment Status
: Unknown
Verified November 2015 by Lars Rombo, Sormland County Council, Sweden.
Recruitment status was: Active, not recruiting
First Posted
: October 5, 2011
Last Update Posted
: November 18, 2015
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vaccine Response Impaired | Biological: hepatitis A vaccine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate |
Study Start Date : | September 2011 |
Estimated Primary Completion Date : | August 2016 |
Estimated Study Completion Date : | August 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: initial single dose of hep A vaccine
The participants will receive a single dose of hepatitis A vaccine at 0+1+6 months
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Biological: hepatitis A vaccine
3 doses of hepatitis A vaccine, given at 0+1+6 months
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Active Comparator: initial double dose
Participants will receive one dose of hepatitis A vaccine in each M. deltoids and an additional dose at 6 months later
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Biological: hepatitis A vaccine
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
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- 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
- seroconversion rates after three doses of hepatitis A vaccine [ Time Frame: 12 months after the first doses ]We determine seroconversion rates before the third vaccine dose (6 months after the first) and at 1 and 6 months after the second dose

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 -
Exclusion Criteria:
- 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
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446978
Sweden | |
Dept infectious diseases | |
Eskilstuna, Sweden, 631 88 | |
Department of infectious diseases | |
Stockholm, Sweden, 17176 | |
Dept infectious diseases | |
Uppsala, Sweden, 75185 | |
Dept infectious diseases | |
Örebro, Sweden, 70185 |
Principal Investigator: | lars rombo, MD | Karolinska Institutet |
Responsible Party: | Lars Rombo, Professor, Sormland County Council, Sweden |
ClinicalTrials.gov Identifier: | NCT01446978 History of Changes |
Other Study ID Numbers: |
Rombo - 2 |
First Posted: | October 5, 2011 Key Record Dates |
Last Update Posted: | November 18, 2015 |
Last Verified: | November 2015 |
Keywords provided by Lars Rombo, Sormland County Council, Sweden:
hepatitis A vaccine TNF-alfa inhibitory drugs Rheumatoid arthritis methotrexate |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Vaccines Methotrexate Immunologic Factors Physiological Effects of Drugs |
Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |