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

Not Applicable

• Conditions: Influenza; Acquired Immune Deficiency Syndrome; HIV Infections
• Interventions: Biological: Mesotherapy

• Registration Number: NCT00758212
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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.

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 Timeline

• Status Verified: 2008-09
• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-23
• Study First Posted: 2008-09-25
• Last Update Submitted: 2008-10-08
• Last Update Posted: 2008-10-09
• Study Start: 2008-11
• Primary Completion: 2009-01
• Study Completion: 2009-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Allergy to eggs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Mesotherapy	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.

Primary Outcome Measures

Name	Time	Method
anti influenza antibody using Hemagglutination inhibition	1 , 3 , 6 months

Secondary Outcome Measures

Name	Time	Method
acceptability of influenza vaccination using mesotherapy	1month

Trial Locations

Locations (1)

Hadassah U. hospital; 🇮🇱 Jerusalem, Israel