NCT00758212

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Influenza
• Acquired Immune Deficiency Syndrome
• HIV Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-01-01
• Completion: 2009-04-01
• First posted: 2008-09-25
• Last updated: 2008-10-09

Locations

1 site across 1 country: Israel