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| Name | Class |
|---|---|
| VINS Bioproducts Ltd. | UNKNOWN |
| Biogentech Co.,LTD | UNKNOWN |
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A single center, prospective cohort, open-label study of rabies post exposure program with equine rabies immunoglobulin (ERIG) and purified chick-embryo cell (PCEC) rabies vaccine in WHO category III exposed patients at Siriraj Hospital, Thailand aims to compare serum RVNA responses between obese (BMI > 30 kg/m2) and normal weight/underweight (BMI < 25 kg/m2) and to evaluate adverse events occurring after immunization on days 7, 14 and 28.
A single center, prospective cohort, open-label study of rabies post exposure program with equine rabies immunoglobulin (ERIG) and purified chick-embryo cell (PCEC) rabies vaccine in WHO category III exposed patients at Siriraj Hospital, Thailand aims to compare serum RVNA responses between obese (BMI > 30 kg/m2) and normal weight/underweight (BMI < 25 kg/m2) and to evaluate adverse events occurring after immunization on days 7, 14 and 28.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal BMI or underweight (< 24 Kg/m2) | Other |
| |
| Obese (BMI > 30 Kg/m2) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Equine Rabies Immunoglobulin | Biological | 40 IU per kg of body weight of ERIG at Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients. | To compare RVNA levels between obese and normal/underweight patients. | At day 7 prior to vaccination. |
| The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients. | To compare RVNA levels between obese and normal/underweight patients. | At day 14 prior to vaccination. |
| The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients. | To compare RVNA levels between obese and normal/underweight patients. | At day 28 prior to vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse event | Number of participants with ERIG or PCEC-related adverse events as assessed by investigator as per CTCAE v4.03. | From day 0 to day 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Siriraj Hospital, Mahidol University | Bangkok | Bangkok | 10700 | Thailand |
No plan to provide individual participant data (IPD). However, other researcher could request IPD from principal investigator.
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| ID | Term |
|---|---|
| D011818 | Rabies |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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|
| Purified chick-embryo cell rabies vaccine | Biological | 1 ml of PCEC Rabies vaccine on days 0, 3, 7, 14 and 28. |
|
|
| D007239 | Infections |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |