Immunogenicity and Safety Study of A New Chromatographically Purified Vero Cell Rabies Vaccine With ID Regimen and ERIG

Queen Saovabha Memorial Institute

Status and phase: Completed; Phase 4

Conditions: Rabies

Treatments: Biological: SPEEDA and TRCS SPEEDA

Study type: Interventional

Funder types: Other

Identifiers

NCT01137045

RC5301

Details and patient eligibility

About

A comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically purified vero cell rabies vaccine (SPEEDA)which is filled by Queen Saovabha Memorial Institute (TRCS SPEEDA)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.

Full description

Rabies is an important world health problem especially in developing countries.Although the case-fatality ratio of human rabies is 100%,the disease is preventable by the modern cell-culture vaccine and rabies immunoglobulin.Post-exposure rabies vaccination with the modified Thai Red Cross intradermal(modified TRC-ID)regimen has been approved by WHO and proven to be immunogenic and effective. It represents a significant saving in vaccine cost and is now established in several developing countries. SPEEDA,chromatography purified vero cell derived rabies vaccine,approved by Thai FDA on 8 April 2009 and drug registration code of SPEEDA is 1C 90022/51. This study has a goal to determine the immunogenicity and safety of SPEEDA and TRCS-SPEEDA (SPEEDA which is filled by Queen Saovabha Memorial Institute)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.

Enrollment: 210 patients

Sex: All

Ages: 15 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• subjects are healthy population older than 15 years.
• subjects are willing to give signed informed consents.
• subjects are willing to give blood samples on recommended days.
• subjects are available for follow up according to the table of administration

Exclusion criteria

• subjects who had received any type of rabies vaccination in the past
• subjects who had received rabies immunoglobulin in the past
• subjects who had known as immunocompromised hosts
• subjects on steroids or any other immunosuppressant
• subjects on concomitant antimalarials
• subjects who have received of any blood products within the previous 3 months
• subjects with history of allergy to any ingredient of the vaccine
• subjects who had known as pregnancy in first recruitment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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210 participants in 6 patient groups

SPEEDA with modified TRC-ID regimen

Active Comparator group

Description:

35 healthy volunteers

Treatment:

Biological: SPEEDA and TRCS SPEEDA

VERORAB with modified TRC-ID regimen

Active Comparator group

Description:

35 healthy volunteers

Treatment:

Biological: SPEEDA and TRCS SPEEDA

SPEEDA with modified TRC-ID regimen plus ERIG

Active Comparator group

Description:

35 healthy volunteers

Treatment:

Biological: SPEEDA and TRCS SPEEDA

VERORAB with modified TRC-ID regimen plus ERIG

Active Comparator group

Description:

35 WHO category III patients

Treatment:

Biological: SPEEDA and TRCS SPEEDA

SPEEDA with ESSEN IM regimen plus ERIG

Active Comparator group

Description:

35 healthy volunteers

Treatment:

Biological: SPEEDA and TRCS SPEEDA

TRCS SPEEDA with modified TRC-ID regimen plus ERIG

Active Comparator group

Description:

35 healthy volunteers

Treatment:

Biological: SPEEDA and TRCS SPEEDA