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| Name | Class |
|---|---|
| Chulalongkorn University | OTHER |
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A four-site intradermal rabies booster vaccination in HIV - infected patients who have ever received primary rabies vaccination could improve their immune response to this kind of vaccine.
A four-site intradermal rabies booster vaccination has shown higher immune response than conventional intramuscular rabies booster vaccination in healthy persons. So, the investigators hypothesized the same outcome in HIV - infected patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Four-site intradermal vaccination | Experimental | 0.1 ml of rabies vaccine is distributed to 4 sites over both arms and thigh intradermally on day 0. Blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14. |
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| Intramuscular vaccination | Active Comparator | 0.5 ml of rabies vaccine is injected to one arm on day 0 and 3.Blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rabies vaccine | Biological | Rabies vaccine is injected according to the protocol then blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14. |
| Measure | Description | Time Frame |
|---|---|---|
| Rabies neutralizing antibody titers | Rabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs) | Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Specific T cell response | Specific T cell response is measured by OX-40 assay | Change from baseline of percentages of rabies-antigen specific CD4+ T cells at 2 weeks |
| Cytokines assessment | A few cytokines levels are measured by multiplex bead array assay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suda Sibunruang, MD | Contact | +66 81 7366076 | sudapunrin@gmail.com | |
| Terapong Tantawichien, MD | Contact | +66 81 7350654 | terapong_tantawichien@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Suda Sibunruang, MD | Queen Saovabha Memorial Institute. Faculty of Medicine, Chulalongkorn university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Saovabha Memorial Institute, Thai Red Cross Society | Recruiting | Bangkok | 10330 | Thailand |
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| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D011819 | Rabies Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Change from baseline of cytokines levels at 1 week |
| D007239 | Infections |