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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1122-2546 | Other Identifier | WHO |
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The purpose of this study is to assess the 4-site "one-week" post-exposure prophylaxis (PEP) regimen as a possible alternative to the 2-site updated Thai Red Cross (TRC) PEP regimen.
Primary objective:
Secondary objectives:
Participants with WHO Category II exposure will receive PEP, using "one-week, 4-site" ID vaccination regimen. Participants with WHO Category III exposure will receive PEP, using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen and pERIG Favirab® or using the updated 2-site TRC (2-2-2-0-2) ID vaccination regimen and pERIG Favirab®. All participants will receive a "single-visit, 4-site" booster vaccination five years later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Patients with WHO Category II exposure receive PEP with PVRV using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later |
|
| Group 2 | Experimental | Patients with WHO Category III exposure receive PEP with PVRV using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen and pERIG Favirab®, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later |
|
| Group 3 | Active Comparator | Patients with WHO Category III exposure receive PEP with PVRV using the updated 2-site TRC (2-2-2-0-2) ID vaccination regimen and pERIG Favirab®, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVRV | Biological | 0.1 mL, 4 site 'one week' (4-4-4-0-0) administered intradermally |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with seroconversion on Day 14 | Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL | Day 14 post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with seroconversion before and after primary vaccination | Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL | Day 0, Day 14, Day 90 |
| Percentage of participants with seroconversion after primary vaccination (antibody persistence) |
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Inclusion Criteria:
For all patients:
For adults:
For children:
Exclusion Criteria:
For all patients:
For infants or toddlers :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Muntinlupa | 1781 | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30890382 | Derived | Quiambao BP, Ambas C, Diego S, Bosch Castells V, Korejwo J, Petit C, Houillon G. Intradermal post-exposure rabies vaccination with purified Vero cell rabies vaccine: Comparison of a one-week, 4-site regimen versus updated Thai Red Cross regimen in a randomized non-inferiority trial in the Philippines. Vaccine. 2019 Apr 10;37(16):2268-2277. doi: 10.1016/j.vaccine.2019.02.083. Epub 2019 Mar 16. |
| Label | URL |
|---|---|
| Related Info | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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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| PVRV and pERIG Favirab® | Biological | 0.1 mL of vaccine administered intradermally in 4 site 'one week' (4-4-4-0-0) regimen, and pERIG Favirab® (volume to be calculated according to the patient' body weight) infiltrated into and around wound(s) |
|
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| PVRV and pERIG Favirab® | Biological | 0.1 mL of vaccine administered intradermally in 2-site TRC (2-2-2-0-2) regimen, and pERIG Favirab® (volume to be calculated according to the patient' body weight) infiltrated into and around wound(s) |
|
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Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL |
| Year 1 to Year 5 |
| Percentage of participants with seroconversion after booster vaccination | Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL | Year 5 + 11 days |
| Geometric mean titers (GMTs) before and after primary vaccination | Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test | Day 0, Day 14, Day 90 |
| GMTs after primary vaccination (antibody persistence) | Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test | Year 1 to Year 5 |
| GMTs after booster vaccination | Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test | Year 5 + 11 days |
| Number of participants reporting solicited injection site reactions following primary and booster vaccination | Solicited injection site reactions are tenderness (for participants aged ≤ 23 months), pain (for participants aged ≥ 2 years), redness and swelling (for all participants) | 7 days after each and any injection |
| Number of participants reporting solicited systemic reactions following primary and booster vaccination | Solicited systemic reactions are Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability for participants aged ≤ 23 months and Fever (Temperature), Headache, Malaise, and Myalgia for participants aged ≥ 2 years | From Day 0 up to 7 days after injection 3, and 7 days after subsequent injections |
| D007239 | Infections |