We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00758212
Recruitment Status : Unknown
Verified September 2008 by Hadassah Medical Organization.
Recruitment status was:  Enrolling by invitation
First Posted : September 25, 2008
Last Update Posted : October 9, 2008
Sponsor:
Information provided by:
Hadassah Medical Organization

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Influenza Acquired Immune Deficiency Syndrome HIV Infections Biological: Mesotherapy Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2008
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Vaxigrip Trivalent Influenza vaccine , diluted 1:10.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. anti influenza antibody using Hemagglutination inhibition [ Time Frame: 1 , 3 , 6 months ]

Secondary Outcome Measures :
  1. acceptability of influenza vaccination using mesotherapy [ Time Frame: 1month ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00758212


Locations
Layout table for location information
Israel
Hadassah U. hospital
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Layout table for investigator information
Principal Investigator: shlomo maayan, md Hadassah Medical Organization
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Shlomo Maayan MD ; Director, Hadassah AIDS Center, Hadassah Medical organization
ClinicalTrials.gov Identifier: NCT00758212    
Other Study ID Numbers: azw6gmHHMO-CTIL
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: October 9, 2008
Last Verified: September 2008
Keywords provided by Hadassah Medical Organization:
Influenza in Humans
Acquired Immune Deficiency Syndrome
Immunization, Active
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Blood-Borne Infections
 Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Immune System Diseases
Slow Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs