Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins

Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins for Post-exposure Rabies Treatment

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01641315

Enrollment

Registered

2012-07-16

Start date

2015-09-30

Completion date

2018-04-30

Last updated

2018-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rabies

Keywords

rabies, rabies immunoglobulin

Brief summary

Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen with rabies immunoglobulin have never been studied in the aspect that the immunity level would above the protective level required by WHO (0.5 IU/ml) for at least a year period. This study would access this subject.

Detailed description

* Controlled trial study * All 75 volunteers who had never had rabies immunization would be enrolled and designated into 3 groups. group 1 : 25 Healthy volunteers age 18 - 60 yr who were attacked by mammals, possible exposed to rabies and had WHO category III exposure, all receive standard post - exposure rabies treatment with 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 IU/kg of equine rabies immune globulin (ERIG). group 2 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,14 and 40 IU/kg of equine rabies immune globulin (ERIG). group 3 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,28 and 40 IU/kg of equine rabies immune globulin (ERIG). 5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28, 90 and 360 for rabies neutralizing antibody titers (RNab). The GMTs of RNab among both groups would be analyzed and compared.

Interventions

BIOLOGICALrabies vaccine

Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0. Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0. Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy volunteers age 18-60 years.

Exclusion criteria

* received prior rabies immunization * pregnancy * immunocompromised conditions

Design outcomes

Primary

Measure	Time frame	Description
Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14	Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period	Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14 would be determined on day 0,14, 28, 90 and 360. Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.

Secondary

Measure	Time frame	Description
Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,28	Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period	Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7 and 28 would be determined on day 0,14, 28, 90 and 360. Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026