Condition category
Infections and Infestations
Date applied
23/01/2006
Date assigned
25/01/2006
Last edited
21/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.cardiology-geneva

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

Publication citations

Additional files

Editorial Notes