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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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Primary hypotheses:
The primary goal of this study is to compare the vaccination groups. Using GMTs to measure immunogenicity of the 3 different vaccination regimens, we will test for non-inferiority between Group I and Group II and between Group I and Group III.
Our hypotheses are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | will receive standard dose (0.5mL) delivered by standard intramuscular injection using a needle and syringe. |
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| Arm II | Experimental | will receive standard dose (0.5mL) delivered by intramuscular injection using the Pharmajet needle-free Stratis device. |
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| Arm III | Experimental | will receive a reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GINI | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Needle-free jet injection technology | The jet injector is based on simple, robust technology employing a spring and requiring no compressed gas, battery, or electricity to generate a liquid needle. PharmaJet has two product lines; one for intramuscular and subcutaneous (IM/SC) delivery of 0.5 mL and one for ID delivery of 0.1 mL. The IM/SC product, called Stratis, was FDA-cleared in 2011 and has a separate reset station to recharge the injector spring, while the ID product, Tropis, is in late stage product development and has the reset function integrated into the injector. Both products employ disposable, single-use, needle-free syringes and filling adapter components. To date the products have been used for routine vaccine delivery as well as in a number of clinical trials (including Inactivated Poliovirus Vaccine (IPV), HPV, and influenza). PharmaJet is working with vaccine manufacturers to co-develop custom pre-fillable syringes, e.g., a tetravalent Dengue vaccine with Inviragen.6 | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
1. Known contraindications to vaccination with Gardasil
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Thai Red Cross AIDS Research Centre | Pathum Wan | Bangkok | 10330 | Thailand |
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