NCT01446978

Brief 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) - 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

4.9 years

First QC Date

October 3, 2011

Last Update Submit

November 17, 2015

Conditions

Vaccine Response Impaired

Keywords

hepatitis A vaccineTNF-alfa inhibitory drugsRheumatoid arthritismethotrexate

Outcome Measures

Primary Outcomes (1)

  • seroconversion after the first dose/doses of hepatitis A vaccine

    ELISA-titers are determined before the first dose/doses and at 1 month later

    one month after the first dose/doses

Secondary Outcomes (1)

  • seroconversion rates after three doses of hepatitis A vaccine

    12 months after the first doses

Study Arms (2)

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

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

Biological: hepatitis A vaccine

Interventions

hepatitis A vaccineBIOLOGICAL

3 doses of hepatitis A vaccine, given at 0+1+6 months

initial single dose of hep A vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dept infectious diseases

Eskilstuna, 631 88, Sweden

Location

Dept infectious diseases

Örebro, 70185, Sweden

Location

Department of infectious diseases

Stockholm, 17176, Sweden

Location

Dept infectious diseases

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

HepatitisArthritis, Rheumatoid

Interventions

Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • lars rombo, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 3, 2011

First Posted

October 5, 2011

Study Start

September 1, 2011

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

SE(4)