NCT01603875

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
5 months until next milestone

Results Posted

Study results publicly available

February 25, 2014

Completed
Last Updated

February 25, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

May 16, 2012

Results QC Date

January 3, 2014

Last Update Submit

January 3, 2014

Conditions

Efficacy of the New CPRV

Keywords

CPRVSPEEDAintradermalpre-exposurebooster

Outcome Measures

Primary Outcomes (5)

  • 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.

    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

Secondary Outcomes (1)

  • Side Effects of the Vaccines. These Include Pain, Swelling, Redness, Myalgia, Rash, Fever. Serious Adverse Events Will Also be Recorded.

    up to 7 days after each injection

Study Arms (3)

PrEP and Simulated PEP with PVRV by intramuscular route

ACTIVE COMPARATOR
Biological: New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).

PrEP and Simulated PEP with new CPRV by intramuscular route

EXPERIMENTAL
Biological: New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).

PrEP and Simulated PEP with new CPRV by intradermal route

EXPERIMENTAL
Biological: New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).

Interventions

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

PrEP and Simulated PEP with PVRV by intramuscular routePrEP and Simulated PEP with new CPRV by intradermal routePrEP and Simulated PEP with new CPRV by intramuscular route

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy
  • Can visit according to the protocol

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Saovabha Memorial Institute

Bangkok, Bangkok, 10330, Thailand

Location

Related Links

Results Point of Contact

Title
Dr. Terapong Tantawichien
Organization
Queen Saovabha Memorial Institute
terapong_tantawichien@hotmail.com
66225201614

Study Officials

  • Terapong Tantawichien, M.D.

    Queen Saovabha Memorial Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jaruboot Angsanakul, Medical Officer 4

Study Record Dates

First Submitted

May 16, 2012

First Posted

May 23, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2013

Study Completion

October 1, 2013

Last Updated

February 25, 2014

Results First Posted

February 25, 2014

Record last verified: 2014-01

Locations

TH(1)