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

Study results available
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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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01603875 on ClinicalTrials.gov