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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00758212
First received: September 23, 2008
Last updated: October 8, 2008
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention
Influenza
Acquired Immune Deficiency Syndrome
HIV Infections
 Biological: Mesotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influenza Vaccination at a Reduced Dose of 1:10 Using Mesotherapy in HIV/AIDS Patients at the Hadassah AIDS Center, Jerusalem

Resource links provided by NLM:

MedlinePlus related topics: Flu HIV/AIDS
U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • anti influenza antibody using Hemagglutination inhibition [ Time Frame: 1 , 3 , 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • acceptability of influenza vaccination using mesotherapy [ Time Frame: 1month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: November 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Vaxigrip Trivalent Influenza vaccine , diluted 1:10.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy to eggs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758212

Locations
Israel
Hadassah U. hospital
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: shlomo maayan, md Hadassah Medical Organization
  More Information

Additional Information:
The mesotherapy service at Hadassah complementary medicine department  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Shlomo Maayan MD ; Director, Hadassah AIDS Center, Hadassah Medical organization
ClinicalTrials.gov Identifier: NCT00758212     History of Changes
Other Study ID Numbers: azw6gmHHMO-CTIL
Study First Received: September 23, 2008
Last Updated: October 8, 2008
Health Authority: Israel: Ethics Commission

Keywords provided by Hadassah Medical Organization:
Influenza in Humans
Acquired Immune Deficiency Syndrome
Immunization, Active

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Influenza, Human
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013