Atorvastatin treatment and vaccination efficacy

ISRCTN	ISRCTN87984926
DOI	https://doi.org/10.1186/ISRCTN87984926
Secondary identifying numbers	N/A

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

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 design	Interventional, double-blind, randomised, placebo-controlled trial
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

Participant type(s)	Patient
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

Cardiology Division

Geneva
1211
Switzerland

Geneva University Hospital (Switzerland)
Hospital/treatment centre

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

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

Intention to publish date
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