Influenza Vaccination at a Reduced Dose Using Mesotherapy in HIV/AIDS Patients at the Hadassah AIDS Center, Jerusalem

October 8, 2008 updated by: Hadassah Medical Organization

Influenza Vaccination at a Reduced Dose of 1:10 Using Mesotherapy in HIV/AIDS Patients at the Hadassah AIDS Center, Jerusalem

Influenza vaccination has proved it's effectiveness over many years of usage including HIV/AIDS patients who are immunocompromised. In those patients, however, a noted rise in HIV viral load which follows intramuscular injection of the vaccine is of unknown significance over the long run. Mesotherapy is a procedure developed and practiced in france by which a reduced and diluted amounts of antigens is being introduced by multiple intradermal injections over the torso and upper back. Mesotherapy is mainly used as a vehicle for introducing pain medicine and cosmetics.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We will test the effectiveness of mesotherapy as a vehicle for influenza vaccination.We will use 1:10th of the amount of seasonal trivalent influenza vaccine in approx.50 HIV/AIDS patients.A control group of approx.50 matched patients for age ,treatment schedule and immune status will receive the regular injection of trivalent vaccine. We will follow patients clinically for symptoms compatible with seasonal influenza and for direct side effects of the vaccine.In addition we will measure anti influenza antibody in the two groups .Follow up will be for 6 months following vaccination.Anti influenza antibody will be measured at 1,3,6months using hemagglutination inhibition (HAI) test.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah U. hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Virologic diagnosis of HIV/AIDS.
  • Any immune derangement is acceptable

Exclusion Criteria:

  • Allergy to eggs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
The experimental group will consist of HIV/AIDS patients(approx.50) who volunteer to receive a reduced dose Influenza vaccine using mesotherapy as a mode of injecting the vaccine intradermally.
Biological: Mesotherapy
The regular seasonal trivalent Influenza vaccine( Vaxigrip) will be diluted 1:10 in saline.The diluted vaccine will be given intra-dermally using Mesotherapy,namely multiple injections given at one time in the torso, back and axillae.
Other Names:
  • Vaxigrip Trivalent Influenza vaccine , diluted 1:10.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
anti influenza antibody using Hemagglutination inhibition
Time Frame: 1 , 3 , 6 months
1 , 3 , 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
acceptability of influenza vaccination using mesotherapy
Time Frame: 1month
1month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: shlomo maayan, md, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

January 1, 2009

Study Completion (Anticipated)

April 1, 2009

Study Registration Dates

First Submitted

September 23, 2008

First Submitted That Met QC Criteria

September 23, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Estimate)

October 9, 2008

Last Update Submitted That Met QC Criteria

October 8, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • azw6gmHHMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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