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

NCT00758212 | Unknown

• 1 other identifier: azw6gmHHMO-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza; Acquired Immune Deficiency Syndrome; HIV Infections

Keywords

Influenza in Humans; Acquired Immune Deficiency Syndrome; Immunization, Active

Outcome Measures

Primary Outcomes (1)

• anti influenza antibody using Hemagglutination inhibition

  1 , 3 , 6 months

Secondary Outcomes (1)

• acceptability of influenza vaccination using mesotherapy

  1month

Study Arms (1)

A

EXPERIMENTAL

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

Interventions

Mesotherapy BIOLOGICAL

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.

Also known as: Vaxigrip Trivalent Influenza vaccine , diluted 1:10.

A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Allergy to eggs

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah U. hospital

Jerusalem, Israel

Location

Related Publications (2)

• 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.

  PMID: 11176770 BACKGROUND

• 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.

  PMID: 15525714 BACKGROUND

MeSH Terms

Conditions

Influenza, Human; Acquired Immunodeficiency Syndrome; HIV Infections; Motor Activity

Interventions

Mesotherapy

Condition Hierarchy (Ancestors)

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; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Cosmetic Techniques; Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy

Study Officials

• shlomo maayan, md

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: April 1, 2009
• Last Updated: October 9, 2008

Record last verified: 2008-09

Locations

IL (1)