N/A N=105 Randomized Prevention

Immune Response in Adults to PrEP and Simulated Booster PEP With a New CPRV

Efficacy of the New CPRV

Bottom Line

View on ClinicalTrials.gov: NCT01603875 ↗

Enrolled (actual)

105

Serious AEs

0.0%

Results posted

Feb 2014

Primary outcome: Primary: Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT) — 0; 0; 0 International unit per ml

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV). (Biological)
Age: Pediatric, Adult · 15+ yrs
Sex: All
Sponsor: Queen Saovabha Memorial Institute
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)	29.16; 45.99; 11.93	—
PRIMARY Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)	29.16; 45.99; 11.93	—
PRIMARY Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)	29.16; 45.99; 11.93	—
PRIMARY Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)	29.16; 45.99; 11.93	—
PRIMARY Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)	29.16; 45.99; 11.93	—
SECONDARY Side Effects of the Vaccines. These Include Pain, Swelling, Redness, Myalgia, Rash, Fever. Serious Adverse Events Will Also be Recorded.	—	—

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.

Eligibility Criteria

Inclusion Criteria

Healthy
Can visit according to the protocol

Exclusion Criteria

Fever
Acute illness
History of rabies vaccination
Allergic to the vaccines' component
Immunosuppressive conditions such as HIV infection, transplantation, chronic renal failure, received steroid or immunosuppressive drugs and anti-malarial drugs within previous two months or any blood products within previous three months
Female participant must not be pregnant
All female participant must have urine pregnancy test negative prior to participate the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01603875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.