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Immunogenicity of Influenza Vaccines in HIV-infected Persons in Thailand

This study is currently recruiting participants.
Verified September 2012 by Centers for Disease Control and Prevention
Sponsor:
Collaborator:
Ministry of Health, Thailand
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01538940
First received: February 21, 2012
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

This study will assess the efficacy of a new intradermal formulation of the trivalent inactivated influenza vaccine compared to the standard intramuscular vaccine in HIV-infected men who have sex with men in Bangkok, Thailand. Relative efficacy of the two different formulations of influenza vaccine will be assessed by comparing immunologic responses to vaccine between the two study arms.


Condition Intervention Phase
Influenza
 Biological: Intradermal vaccine
Biological: Intramuscular vaccine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial to Compare the Immunogenicity of Intramuscular Versus Intradermal Trivalent Inactivated Split Virion Influenza Vaccine in HIV-infected Men Who Have Sex With Men in Bangkok, Thailand

Resource links provided by NLM:

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

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Antibody titers [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine


Secondary Outcome Measures:
  • Antibody titers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine

  • Antibody titers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine


Estimated Enrollment: 480
Study Start Date: November 2011
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HIV+, CD4<200, ID vaccine Biological: Intradermal vaccine
15ug
Active Comparator: HIV+, CD4<200, IM vaccine Biological: Intramuscular vaccine
15ug
Active Comparator: HIV+, CD4>=200, ID vaccine Biological: Intradermal vaccine
15ug
Active Comparator: HIV+, CD4 >=200, IM vaccine Biological: Intramuscular vaccine
15ug
HIV-, ID vaccine Biological: Intradermal vaccine
15ug
HIV-, IM vaccine Biological: Intramuscular vaccine
15ug

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Thai men by nationality who have sex with men
  • HIV-infected or HIV-uninfected men
  • At least 18 years of age
  • Willing and able to provide written informed consent
  • Availability and commitment for 12 months of study follow-up (3 study visits)

Exclusion Criteria:

  • Men with severe allergies to chicken eggs (they will specifically be asked about severe egg allergies during the screening visit; appendix C1)
  • Men > 60 years of age
  • Men who have had a severe reaction to influenza vaccine in the past
  • Men with a history of Guillain-Barré Syndrome
  • Men who received influenza vaccine within 12 months prior to enrollment
  • Men who are on steroid therapy or other immunosuppressant medications
  • Men who received any vaccine in the 4 weeks prior to the first study visit or who plan to receive a vaccine (other than influenza vaccine provided through the study protocol) in the 4 weeks following the first study visit
  • Men who received an experimental agent (vaccine, drug, biologic, device, blood product, medication) within 1 month prior to enrollment in this study, or expect to receive an experimental agent during the 12 month study period
  • Men who have any condition, in the opinion of the investigator, that would place them at an unacceptable risk of injury or render them unable to meet requirements of the protocol. (e.g., severe reaction to another vaccine, blood clotting disorder, inflammatory skin condition).
  • Foreign (non-Thai) nationality
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538940

Locations
Thailand
Silom Community Clinic Recruiting
Bangkok, Thailand
Contact: Pornchai Sornsathapornkul, RN     +66-2-634-2917     fnpst@diamond.mahidol.ac.th    
Sponsors and Collaborators
Centers for Disease Control and Prevention
Ministry of Health, Thailand
Investigators
Principal Investigator: Charung Muangchana, MD Ministry of Health, Thailand
Principal Investigator: Prasert Thongcharoen, MD Influenza Foundation of Thailand
  More Information

Additional Information:
Website for clinic where the study is being conducted.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01538940     History of Changes
Other Study ID Numbers: CDC-NCIRD-6181, 1U01GH000152
Study First Received: February 21, 2012
Last Updated: September 10, 2012
Health Authority: Thailand: Ministry of Public Health
United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Influenza
Vaccine
Thailand

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013