Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- seroconversion after the first dose/doses of hepatitis A vaccine
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
排除标准
- •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)
结局指标
主要结局
seroconversion after the first dose/doses of hepatitis A vaccine
时间窗: one month after the first dose/doses
ELISA-titers are determined before the first dose/doses and at 1 month later
次要结局
- seroconversion rates after three doses of hepatitis A vaccine(12 months after the first doses)
研究者
Lars Rombo
Professor
Sormland County Council, Sweden