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Completed

NCT Number: NCT01641315

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

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.

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Key information

Conditions

Rabies Infections Mononegavirales Infections RNA Virus Infections Rhabdoviridae Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Saovabha Memorial Institute

Bangkok, 10330, Thailand

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteers age 18-60 years.

Exclusion criteria

  • received prior rabies immunization
  • pregnancy
  • immunocompromised conditions

Treatment and study plan

Rabies vaccine

Biological

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.

Other names: Equine rabies immunoglobulin produced by Thai Red Cross

Primary outcomes

  1. Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14

    Time frame: 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 outcomes

  1. Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,28

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Queen Saovabha Memorial Institute

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 16, 2012
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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