Immune Response in Adults to PrEP and Simulated Booster PEP With a New CPRV
NCT01603875 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105
Last updated 2014-02-25
Summary
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.
Conditions
- Efficacy of the New CPRV
Interventions
- BIOLOGICAL
-
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
Sponsors & Collaborators
-
Queen Saovabha Memorial Institute
lead OTHER
Principal Investigators
-
Terapong Tantawichien, M.D. · Queen Saovabha Memorial Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2013-07-31
- Completion
- 2013-10-31
Countries
- Thailand
Study Locations
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