Atorvastatin treatment and vaccination efficacy
ISRCTN | ISRCTN87984926 |
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DOI | https://doi.org/10.1186/ISRCTN87984926 |
Secondary identifying numbers | N/A |
- Submission date
- 23/01/2006
- Registration date
- 25/01/2006
- Last edited
- 21/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Francois Mach
Scientific
Scientific
Cardiology Division
Geneva University Hospital
24 Rue Micheli-du-Crest
Geneva
1211
Switzerland
Phone | +41 (0)22 382 72 34 |
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francois.mach@medecine.unige.ch |
Study information
Study design | Interventional, double-blind, randomised, placebo-controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | Statin treatment may modulate, either negatively or positively, antibody responses to vaccination antigens. |
Ethics approval(s) | The protocol was approved by the Ethics Committee of the Geneva University Hospital (CE-04-029) and written informed consent was obtained from all participants |
Health condition(s) or problem(s) studied | Hepatitis A |
Intervention | Subjects were immunised against hepatitis A and subsequently received atorvastatin (40 mg per day) or placebo for a period of 28 days after immunisation. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Atorvastatin |
Primary outcome measure | The main outcome variable was the achievement of antibody levels greater than 20 IU/l against the hepatitis A virus one month after vaccination. |
Secondary outcome measures | 1. A secondary outcome variable was the mean log-transformed antibody titre 2. To document the effects of atorvastatin on total blood cholesterol, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C), triglycerides, and high-sensitivity C-Reactive Protein (hs-CRP) |
Overall study start date | 01/11/2004 |
Completion date | 30/06/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 312 |
Key inclusion criteria | Men and women who were greater than 18 years old were eligible for inclusion if they had neither morbidities nor immunity to hepatitis A |
Key exclusion criteria | 1. Anti-hepatitis A antibodies greater than 10 IU/l 2. Hypercholesterolemia 3. Hepatitis 4. Myositis 5. Chronic alcohol abuse 6. Pregnant or breast-feeding women 7. Volunteers on drug therapy except oral contraceptives |
Date of first enrolment | 01/11/2004 |
Date of final enrolment | 30/06/2005 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Cardiology Division
Geneva
1211
Switzerland
1211
Switzerland
Sponsor information
Geneva University Hospital (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Cardiology Division
24 rue Micheli-du-Crest
Geneva
1211
Switzerland
Phone | +41 (0)22 372 72 00 |
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marjorie.burkhard@hcuge.ch | |
Website | http://www.cardiology-geneva |
https://ror.org/01m1pv723 |
Funders
Funder type
University/education
Geneva University Hospital (Switzerland) - Department of Medicine
No information available
University of Geneva Cardiology Foundation (GECOR) (Switzerland) - had no role in the study design, analysis of data or report writing
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |