ISRCTN ISRCTN87984926
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

Cardiology Division
Geneva University Hospital
24 Rue Micheli-du-Crest
Geneva
1211
Switzerland

Phone +41 (0)22 382 72 34
Email francois.mach@medecine.unige.ch

Study information

Study designInterventional, double-blind, randomised, placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesStatin 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) studiedHepatitis A
InterventionSubjects were immunised against hepatitis A and subsequently received atorvastatin (40 mg per day) or placebo for a period of 28 days after immunisation.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Atorvastatin
Primary outcome measureThe 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 measures1. 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 date01/11/2004
Completion date30/06/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants312
Key inclusion criteriaMen 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 criteria1. 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 enrolment01/11/2004
Date of final enrolment30/06/2005

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Cardiology Division
Geneva
1211
Switzerland

Sponsor information

Geneva University Hospital (Switzerland)
Hospital/treatment centre

Cardiology Division
24 rue Micheli-du-Crest
Geneva
1211
Switzerland

Phone +41 (0)22 372 72 00
Email marjorie.burkhard@hcuge.ch
Website http://www.cardiology-geneva
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan