Contact information
Type
Scientific
Primary contact
Prof Francois Mach
ORCID ID
Contact details
Cardiology Division
Geneva University Hospital
24 Rue Micheli-du-Crest
Geneva
1211
Switzerland
+41 (0)22 382 72 34
francois.mach@medecine.unige.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Statin treatment may modulate, either negatively or positively, antibody responses to vaccination antigens.
Ethics approval
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
Study design
Interventional, double-blind, randomised, placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Atorvastatin
Primary outcome measures
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 trial start date
01/11/2004
Overall trial end date
30/06/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
312
Participant 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
Recruitment start date
01/11/2004
Recruitment end date
30/06/2005
Locations
Countries of recruitment
Switzerland
Trial participating centre
Cardiology Division
Geneva
1211
Switzerland
Sponsor information
Organisation
Geneva University Hospital (Switzerland)
Sponsor details
Cardiology Division
24 rue Micheli-du-Crest
Geneva
1211
Switzerland
+41 (0)22 372 72 00
marjorie.burkhard@hcuge.ch
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Geneva University Hospital (Switzerland) - Department of Medicine
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Geneva Cardiology Foundation (GECOR) (Switzerland) - had no role in the study design, analysis of data or report writing
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary