A randomized, double-blind, placebo-controlled clinical trial to evaluate the immunogenicity enhancement and safety after inoculation with 4-cell culture influenza surface antigen vaccine by eating aloe vera gel powder for 8 weeks in healthy adults
- Conditions
- Factors influencing health status and contact with health servisces
- Registration Number
- KCT0002843
- Lead Sponsor
- Chonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1) Male and female subject aged between 39 years and 70 years
2) subjects who decided to voluntarily participate in this clinical trial and complete to sign on the informed consent
1) subjects who got a vaccination within 6 months before screening
2) subjects who got any vaccination within 1 months from screening or will sceduled vaccination in the intake period(8 weeks)
3) subjects who got immunosuppressant or immunemodifying drug within in the 3 months from screening
? such as Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus,Everolimus, Sirolimus, Cyclophophamid, 6-mercaptopurine, Methotrexate, Rapamycin, Leflunomide
? subjects who had received steroid more than 14 days within 3 months of screening
4) subjects who had received or are scheduled to receive those products ( Immunoglobulin or blood-derived product ) within 3 months from screening
5) subject who got the psychotropic drugs and narcotic analgesic drugs within 6 months of screening
6) subjects who have a history of hypersensitivity about vaccination such as Guillang-Barre syndrome
7) hemophilia patients at risk of serious bleeding with intramuscular injection or who had taken an anticoagulant
8) subjects who have other clinically significant medical history of liver-biliary system, renal system, nervous system(central or peripheral), respiratory system(asthma, etc.), endocrine system(diabetes, hyperlipidemia, etc.), cardiovascular system(congestive heart failure, coronary heart disease, myocardial infarction, uncontrollable hypertension, etc.), blood tumor, urinary system, psychiatry, musculoskeletal system, immune system(rheumatoid arthritis, systemic lupus erythematosus, etc.) or who were considered by the investigator to be ineligible for the study
9) subjects who have hypersensitive or clinically significant hypersensitivity history due to drug, experimental product((Aloe vera gel), influenza vaccination and Other ingredients(formalin, etc.)
10) subjects who are suspected drug abuse or have a medical history of dependent on drug
11) subjects who have a medical history of gastrointestinal diseases(Crohn's disease, etc.) or operation(except appendectomy or herniotomy)
12) subject who drink constantly(21 units/week excess) or have a medical history of dependent on alcohol abuse
13) subject who show the following results in the screening test
? AST, ALT > more than 2 times of the upper limit
? Serum creatinine > 2.0 mg/dL
14) subjects who involved in other clinical trial within 2 months before screening test
15) subjects who are planning a pregnancy or are breastfeeding during this study
16) subject who do not perform adequate contraception(using a condom, contraceptive diaphragm, intrauterine contraceptive device from 21 days before vaccination with the investigational product or whose male partner had undergone a vasectomy) in the urban eligible women
17) subject who deemed inappropriate to participate this clinical trial by research director due to other reasons including screening test
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seroprotection rate of HI antibody
- Secondary Outcome Measures
Name Time Method Frequency, severity, and duration of URI;GMT increase fold of antibody titer;Seroconversion rate;Seroprotection rate;INF-? producing cell