NCT01548326

Brief Summary

The purpose of this study is to determine whether short-term Atorvastatin can increase the immunity response to hepatitis B vaccination in vaccine Nonresponders.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

10 months

First QC Date

February 27, 2012

Last Update Submit

March 6, 2012

Conditions

Hepatitis BVaccination Failure

Keywords

Vaccination FailureNonresponderHepatitis B virusAtorvastatinImmunization against viral Hepatitis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in serum HBsAb level

    HBsAb level in serum measurement with quantitative ELIZA method

    1 month after vaccination

Secondary Outcomes (4)

  • IL-4 level in WBC culture

    1 month after vaccination

  • IL 17 level in WBC culture

    1 month after vaccination

  • TGF-beta level in WBC culture

    1 month after vaccination

  • IFN-gamma level in WBC culture

    1 month after vaccination

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

will receive one 40 mg Atorvastatin tablet orally per day for 10 days and in 5th day 1 dose of recombinant yeast-derived Hepatitis B vaccine intramuscular in left Deltoid muscle

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

will receive one Placebo tablet orally per day for 10 days and in 5th day 1 dose of recombinant yeast-derived Hepatitis B vaccine intramuscular in left Deltoid muscle

Drug: placebo

Interventions

AtorvastatinDRUG

one 40 mg Atorvastatin tablet orally per day for 10 days

Atorvastatin
placeboDRUG

one Placebo tablet orally per day for 10 days

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Previous 3 dose hepatitis B vaccination
  • Negative HBc Ab
  • Negative HBs Ag
  • HBs Ab less than 10 in ELIZA

You may not qualify if:

  • positive serologic evidence of Hepatitis B infection
  • Chronic use of Atorvastatin
  • Immunosuppressive Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baqiyatallah University of Medical Sciences

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Nematollah Jonaidi Jafari, MD

    Baqiyatallah University of Medical Sciencesc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Health Research Center

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 8, 2012

Study Start

September 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

IR(1)