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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01GH000152 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Ministry of Health, Thailand | OTHER_GOV |
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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.
This study will assess the efficacy of a new intradermal formulation of the trivalent inactivated influenza vaccine (TIV) compared to standard intramuscular TIV in HIV-infected men who have sex with men (MSM) in Bangkok, Thailand. Eligible participants will be randomized to receive standard full-dose intramuscular vaccine versus full-dose intradermal vaccine. Full dose (15 micrograms) intradermal TIV will be licensed for use in adult's ≥ 60 years of age in Thailand in mid-2011. In this study, intradermal TIV will be used off-label as the 15 microgram dose will be administered to individuals < 60 years of age. Efficacy of the two different formulations of influenza vaccine will be assessed by comparing immunologic responses to vaccine between the two HIV-infected study arms. Both humoral (influenza antibody) and cell-mediated (influenza- specific CD4 and CD8 T cell) immune responses will be evaluated. Humoral and cell-mediated immune responses among HIV-infected individuals with CD4 cell counts less than 200 per microliter will also be compared to immune responses in HIV-infected individuals with CD4 cell counts of 200 per microliter or greater. A small HIV-uninfected MSM control group will also be enrolled (with persons randomized into either an intramuscular or intradermal TIV arm) to serve as a comparator group for the cell-mediated immunity studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV+, CD4<200, ID vaccine | Active Comparator | Humoral and cell-mediated immune responses among HIV-infected individuals with CD4 cell counts less than 200 per microliter will be compared to immune responses in HIV-infected individuals with CD4 cell counts of 200 per microliter or greater. |
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| HIV+, CD4<200, IM vaccine | Active Comparator | Humoral and cell-mediated immune responses among HIV-infected individuals with CD4 cell counts less than 200 per microliter will be compared to immune responses in HIV-infected individuals with CD4 cell counts of 200 per microliter or greater. |
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| HIV+, CD4>=200, ID vaccine | Active Comparator | Humoral and cell-mediated immune responses among HIV-infected individuals with CD4 cell counts less than 200 per microliter will be compared to immune responses in HIV-infected individuals with CD4 cell counts of 200 per microliter or greater. |
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| HIV+, CD4 >=200, IM vaccine | Active Comparator | Humoral and cell-mediated immune responses among HIV-infected individuals with CD4 cell counts less than 200 per microliter will be compared to immune responses in HIV-infected individuals with CD4 cell counts of 200 per microliter or greater. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intradermal vaccine | Biological | 15ug |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charung Muangchana, MD | Ministry of Health, Thailand | Principal Investigator |
| Prasert Thongcharoen, MD | Influenza Foundation of Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silom Community Clinic | Bangkok | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31045222 | Derived | Amoah S, Mishina M, Praphasiri P, Cao W, Kim JH, Liepkalns JS, Guo Z, Carney PJ, Chang JC, Fernandez S, Garg S, Beacham L, Holtz TH, Curlin ME, Dawood F, Olsen SJ, Gangappa S, Stevens J, Sambhara S. Standard-Dose Intradermal Influenza Vaccine Elicits Cellular Immune Responses Similar to Those of Intramuscular Vaccine in Men With and Those Without HIV Infection. J Infect Dis. 2019 Jul 31;220(5):743-751. doi: 10.1093/infdis/jiz205. | |
| 26486702 | Derived |
| Label | URL |
|---|---|
| Website for clinic where the study is being conducted. | View source |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| HIV-, ID vaccine |
| Other |
A small HIV-uninfected MSM control group will be enrolled (with persons randomized into either an intramuscular or intradermal TIV arm) to serve as a comparator group for the cell-mediated immunity studies. |
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| HIV-, IM vaccine | Other | A small HIV-uninfected MSM control group will be enrolled (with persons randomized into either an intramuscular or intradermal TIV arm) to serve as a comparator group for the cell-mediated immunity studies. |
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| Intramuscular vaccine | Biological | 15ug |
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| 12 months |
| Garg S, Thongcharoen P, Praphasiri P, Chitwarakorn A, Sathirapanya P, Fernandez S, Rungrojcharoenkit K, Chonwattana W, Mock PA, Sukwicha W, Katz JM, Widdowson MA, Curlin ME, Gibbons RV, Holtz TH, Dawood FS, Olsen SJ. Randomized Controlled Trial to Compare Immunogenicity of Standard-Dose Intramuscular Versus Intradermal Trivalent Inactivated Influenza Vaccine in HIV-Infected Men Who Have Sex With Men in Bangkok, Thailand. Clin Infect Dis. 2016 Feb 1;62(3):383-391. doi: 10.1093/cid/civ884. Epub 2015 Oct 20. |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |