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Pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies vaccine.
After the pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients on day 42 are 0.5 IU/ml or more.
And Simulated post-exposure rabies booster vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies vaccine.
After the simulated post-exposure rabies booster vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients on day 14 after the booster are 0.5 IU/ml or more.
Pre-exposure vaccination will be done according to standard protocol. Participants will be injected with one dose on day 0, 7 and 28. Blood samples will be taken on day 0, 28 and 42 after the first vaccination dose.
360 days later, participants will receive simulated post-exposure rabies booster vaccination one dose on day 0 and 3. Blood samples will be taken again on day 0(360 days) and 14(374 days) after the booster vaccination.
Rabies neutralizing antibody levels will be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT). And the levels of 0.5 IU/ml or more is considered acceptable protective level.
For statistical analysis, percentage of subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time. The average of the titer used in this study is Geometric mean titer(GMT). 95 percent confidence interval(95% CI) of the GMT will be calculated for each study group from individual measurements of serum rabies antibody levels at each sampling time. One-way ANOVA would be used to calculated the significance of the difference between the GMT of three groups, SPEEDA® intradermal injection, SPEEDA® intramuscular injection and PVRV intramuscular injection. The primary criterion for this comparison are the rabies antibody value on day 42 (2 weeks after the third vaccine dose of pre-exposure vaccination) and on day 374(2 weeks after the first vaccine dose of booster vaccination). Results will be deemed statistically significant at p < 0.05. Safety data (immediate, local and systemic reactions) were summarized as numbers and percentages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PrEP and Simulated PEP with PVRV by intramuscular route | Active Comparator |
| |
| PrEP and Simulated PEP with new CPRV by intramuscular route | Experimental |
| |
| PrEP and Simulated PEP with new CPRV by intradermal route | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV). | Biological | new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) | Blood samples will be drawn on day 0(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time. | on day 0 |
| Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) | Blood samples will be drawn on day 28(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time. | on day 28 |
| Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) | Blood samples will be drawn on day 42(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time. | on day 42 |
| Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) | Blood samples will be drawn on day 360(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time. |
| Measure | Description | Time Frame |
|---|---|---|
| Side Effects of the Vaccines. These Include Pain, Swelling, Redness, Myalgia, Rash, Fever. Serious Adverse Events Will Also be Recorded. | There are five injections, on day 0, 7, 28, 360 and 363. The side effects will be record in number and percentage. | up to 7 days after each injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terapong Tantawichien, M.D. | Queen Saovabha Memorial Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Saovabha Memorial Institute | Bangkok | Bangkok | 10330 | Thailand |
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| Label | URL |
|---|---|
| Contact information | View source |
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We recruited 66 subjects from Faculty of Veterinarian, Chulalongkorn University. The recruitment held between June 25, 2012 and July 2, 2012. Others 39 subjects was recruited from Faculty of Veterinarian, Mahanakorn University of Technology.
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| ID | Title | Description |
|---|---|---|
| FG000 | PrEP and Simulated PEP With PVRV by Intramuscular Route | New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention |
| FG001 | PrEP and Simulated PEP With New CPRV by Intramuscular Route | New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention |
| FG002 | PrEP and Simulated PEP With New CPRV by Intradermal Route | New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PrEP and Simulated PEP With PVRV by Intramuscular Route | New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention |
| BG001 | PrEP and Simulated PEP With New CPRV by Intramuscular Route |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) | Blood samples will be drawn on day 0(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time. | Posted | Geometric Mean | Full Range | International unit per ml | on day 0 |
|
42 days since the first dose was administered. One year later, 14 days since the first booster dose was administered.
Pain, pruritus, erythema, induration, fever, urticaria, arthralgia, myalgia, dizziness, headache, nausea, vomiting, lymphadenopathy were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PrEP and Simulated PEP With PVRV by Intramuscular Route | New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Terapong Tantawichien | Queen Saovabha Memorial Institute | 66225201614 | 125 | terapong_tantawichien@hotmail.com |
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| on day 360 |
| Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) | Blood samples will be drawn on day 374(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time. | on day 374 |
| Protocol Violation |
|
New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention |
| BG002 | PrEP and Simulated PEP With New CPRV by Intradermal Route | New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PrEP and Simulated PEP With New CPRV by Intramuscular Route |
New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention |
| OG002 | PrEP and Simulated PEP With New CPRV by Intradermal Route | New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention |
|
|
| Primary | Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) | Blood samples will be drawn on day 28(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time. | Posted | Geometric Mean | Full Range | International unit per ml | on day 28 |
|
|
|
| Primary | Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) | Blood samples will be drawn on day 42(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time. | Posted | Geometric Mean | Full Range | International unit per ml | on day 42 |
|
|
|
| Primary | Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) | Blood samples will be drawn on day 360(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time. | Posted | Geometric Mean | Full Range | International unit per ml | on day 360 |
|
|
|
| Primary | Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) | Blood samples will be drawn on day 374(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time. | Posted | Geometric Mean | Full Range | International unit per ml | on day 374 |
|
|
|
| Secondary | Side Effects of the Vaccines. These Include Pain, Swelling, Redness, Myalgia, Rash, Fever. Serious Adverse Events Will Also be Recorded. | There are five injections, on day 0, 7, 28, 360 and 363. The side effects will be record in number and percentage. | Not Posted | up to 7 days after each injection |
| 0 |
| 35 |
| 35 |
| 35 |
| EG001 | PrEP and Simulated PEP With New CPRV by Intramuscular Route | New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention | 0 | 35 | 35 | 35 |
| EG002 | PrEP and Simulated PEP With New CPRV by Intradermal Route | New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention | 0 | 35 | 35 | 35 |
| pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| induration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| fever | General disorders | Systematic Assessment |
|
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