Trial | NCT01538940  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    480
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.
Study Started
Nov 30
2011
Primary Completion
Jul 31
2013
Anticipated
Last Update
Sep 11
2012
Estimate

Biological Intradermal vaccine

15ug

Biological Intramuscular vaccine

15ug

HIV+, CD4<200, ID vaccine Active Comparator

HIV+, CD4<200, IM vaccine Active Comparator

HIV+, CD4>=200, ID vaccine Active Comparator

HIV+, CD4 >=200, IM vaccine Active Comparator

HIV-, ID vaccine Other

HIV-, IM vaccine Other

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
No Results Posted