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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Influenza, Acquired Immune Deficiency Syndrome, HIV Infections

Intervention / Treatment
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* Biological: Mesotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Virologic diagnosis of HIV/AIDS. Any immune derangement is acceptable Exclusion Criteria: Allergy to eggs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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<br>* 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.<br>* Other names: Vaxigrip Trivalent Influenza vaccine , diluted 1:10.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti influenza antibody using Hemagglutination inhibition |  | 1 , 3 , 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acceptability of influenza vaccination using mesotherapy |  | 1month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza in Humans, Acquired Immune Deficiency Syndrome, Immunization, Active