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

Primary Purpose

Influenza, Acquired Immune Deficiency Syndrome, HIV Infections

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Mesotherapy
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza focused on measuring Influenza in Humans, Acquired Immune Deficiency Syndrome, Immunization, Active

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy to eggs

Sites / Locations

  • Hadassah U. hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

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.

Outcomes

Primary Outcome Measures

anti influenza antibody using Hemagglutination inhibition

Secondary Outcome Measures

acceptability of influenza vaccination using mesotherapy

Full Information

First Posted
September 23, 2008
Last Updated
October 8, 2008
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00758212
Brief Title
Influenza Vaccination at a Reduced Dose Using Mesotherapy in HIV/AIDS Patients at the Hadassah AIDS Center, Jerusalem
Official Title
Influenza Vaccination at a Reduced Dose of 1:10 Using Mesotherapy in HIV/AIDS Patients at the Hadassah AIDS Center, Jerusalem
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
January 2009 (Anticipated)
Study Completion Date
April 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Acquired Immune Deficiency Syndrome, HIV Infections
Keywords
Influenza in Humans, Acquired Immune Deficiency Syndrome, Immunization, Active

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Mesotherapy
Other Intervention Name(s)
Vaxigrip Trivalent Influenza vaccine , diluted 1:10.
Intervention Description
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.
Primary Outcome Measure Information:
Title
anti influenza antibody using Hemagglutination inhibition
Time Frame
1 , 3 , 6 months
Secondary Outcome Measure Information:
Title
acceptability of influenza vaccination using mesotherapy
Time Frame
1month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Virologic diagnosis of HIV/AIDS. Any immune derangement is acceptable Exclusion Criteria: Allergy to eggs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shlomo maayan, md
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah U. hospital
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
11176770
Citation
Lin JC, Nichol KL. Excess mortality due to pneumonia or influenza during influenza seasons among persons with acquired immunodeficiency syndrome. Arch Intern Med. 2001 Feb 12;161(3):441-6. doi: 10.1001/archinte.161.3.441.
Results Reference
background
PubMed Identifier
15525714
Citation
Kenney RT, Frech SA, Muenz LR, Villar CP, Glenn GM. Dose sparing with intradermal injection of influenza vaccine. N Engl J Med. 2004 Nov 25;351(22):2295-301. doi: 10.1056/NEJMoa043540. Epub 2004 Nov 3.
Results Reference
background

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

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