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Immunogenicity of Influenza Vaccines in HIV-infected Persons in Thailand

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Centers for Disease Control and Prevention.
Recruitment status was  Recruiting
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

February 21, 2012
September 10, 2012
November 2011
July 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01538940 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Immunogenicity of Influenza Vaccines in HIV-infected Persons in Thailand
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Influenza
  • Biological: Intradermal vaccine
    15ug
  • Biological: Intramuscular vaccine
    15ug
  • Active Comparator: HIV+, CD4<200, ID vaccine
    Intervention: Biological: Intradermal vaccine
  • Active Comparator: HIV+, CD4<200, IM vaccine
    Intervention: Biological: Intramuscular vaccine
  • Active Comparator: HIV+, CD4>=200, ID vaccine
    Intervention: Biological: Intradermal vaccine
  • Active Comparator: HIV+, CD4 >=200, IM vaccine
    Intervention: Biological: Intramuscular vaccine
  • HIV-, ID vaccine
    Intervention: Biological: Intradermal vaccine
  • HIV-, IM vaccine
    Intervention: Biological: Intramuscular vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
480
Not Provided
July 2013   (final data collection date for primary outcome measure)

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
Male
18 Years to 60 Years
Yes
Thailand
 
NCT01538940
CDC-NCIRD-6181, 1U01GH000152
No
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
Ministry of Health, Thailand
Principal Investigator: Charung Muangchana, MD Ministry of Health, Thailand
Principal Investigator: Prasert Thongcharoen, MD Influenza Foundation of Thailand
Centers for Disease Control and Prevention
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP