Immunogenicity of Influenza Vaccines in HIV-infected Persons in Thailand

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Influenza

Intervention / Treatment
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* Biological: Intradermal vaccine
* Biological: Intramuscular vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIV+, CD4<200, ID vaccine<br> | Biological: Intradermal vaccine<br>* 15ug<br>|
| Active Comparator: HIV+, CD4<200, IM vaccine<br> | Biological: Intramuscular vaccine<br>* 15ug<br>|
| Active Comparator: HIV+, CD4>=200, ID vaccine<br> | Biological: Intradermal vaccine<br>* 15ug<br>|
| Active Comparator: HIV+, CD4 >=200, IM vaccine<br> | Biological: Intramuscular vaccine<br>* 15ug<br>|
| Other: HIV-, ID vaccine<br> | Biological: Intradermal vaccine<br>* 15ug<br>|
| Other: HIV-, IM vaccine<br> | Biological: Intramuscular vaccine<br>* 15ug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody titers | Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody titers | Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine | 6 months | 
| Antibody titers | Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Vaccine, Thailand