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A comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically purified vero cell rabies vaccine (SPEEDA)which is filled by Queen Saovabha Memorial Institute (TRCS SPEEDA)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.
Rabies is an important world health problem especially in developing countries.Although the case-fatality ratio of human rabies is 100%,the disease is preventable by the modern cell-culture vaccine and rabies immunoglobulin.Post-exposure rabies vaccination with the modified Thai Red Cross intradermal(modified TRC-ID)regimen has been approved by WHO and proven to be immunogenic and effective. It represents a significant saving in vaccine cost and is now established in several developing countries. SPEEDA,chromatography purified vero cell derived rabies vaccine,approved by Thai FDA on 8 April 2009 and drug registration code of SPEEDA is 1C 90022/51. This study has a goal to determine the immunogenicity and safety of SPEEDA and TRCS-SPEEDA (SPEEDA which is filled by Queen Saovabha Memorial Institute)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPEEDA with modified TRC-ID regimen | Active Comparator | 35 healthy volunteers |
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| VERORAB with modified TRC-ID regimen | Active Comparator | 35 healthy volunteers |
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| SPEEDA with modified TRC-ID regimen plus ERIG | Active Comparator | 35 healthy volunteers |
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| VERORAB with modified TRC-ID regimen plus ERIG | Active Comparator | 35 WHO category III patients |
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| SPEEDA with ESSEN IM regimen plus ERIG | Active Comparator | 35 healthy volunteers |
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| TRCS SPEEDA with modified TRC-ID regimen plus ERIG | Active Comparator | 35 healthy volunteers |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPEEDA and TRCS SPEEDA | Biological | For modified TRC-ID regimen,0.1 ml of SPEEDA, TRCS SPEEDA or VERORAB will be given at each of two sites,intradermally on upper arms on days 0,3,7 and 28. For ESSEN regimen, 1 vial of SPEEDA will be given intramuscularly at upper arm on days 0,3,7,14 and 28. For ERIG,it would be given in a single dose 40 IU/Kg at the same time as the first dose of vaccine. ERIG will be infiltrated around and into all wounds as recommended by WHO for patients in group IV and injected intramuscular at each of both gluteal areas for participants in group III,V,VI |
| Measure | Description | Time Frame |
|---|---|---|
| immunogenicity (the level of rabies neutralizing antibodies by RFFIT test) | The immunogenicity (Rabies neutralizing antibodies) would be checked from the blood samples for 7 times (on days 0,7,14,28,90,180 and 360)for one year duration in each phase. | 32 months |
| Measure | Description | Time Frame |
|---|---|---|
| safety | This would based on general examination, local examination and subjective evaluation of both solicited and unsolicited adverse events. | 32 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terapong Tantawichien, MD.,Prof | Queen Saovabha Memorial Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suda Sibunruang | Bangkok | 10130 | Thailand | |||
| Queen Saovabha Memorial Institute |
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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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| Bangkok |
| 10330 |
| Thailand |
| D007239 | Infections |