MedTrace Logo

Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs

NCT01446978 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-11-18

No results posted yet for this study

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

Conditions

  • Vaccine Response Impaired

Interventions

BIOLOGICAL

hepatitis A vaccine

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

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

Sponsors & Collaborators

  • Sormland County Council, Sweden

    lead OTHER

Principal Investigators

  • lars rombo, MD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01446978 on ClinicalTrials.gov