Skip to main content
OpenTrials
Completed

NCT Number: NCT01610362

Human Rabies Immunoglobulin (HRIG)- Dosage Determination and Interference With the Active Immune Response

Dosage of rabies immune globulin was calculated from the victim's body weight, then the amount of rabies immune globulin would be injected as much as possible to all of the wounds. Increase dosage of rabies immune globulin was needed in situation of multiple severe bite-wounds especially among children whose had lower body weight than adults. Our study would be conducted in order to determine whether the increase dosage of rabies immune globulin would interfere with the protective antibody levels against rabies.

Completed

Looking for future studies?

Notify Me

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, Thai Red Cross Society

Bangkok, 10330, Thailand

About this study

  • Controlled trial study.
  • All 50 volunteers who had never had rabies immunization would be enrolled and designated into 2 groups.

group 1 : 15 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 20 IU/kg of human rabies immune globulin (HRIG).

group 2 : 35 Healthy volunteers age 18 - 60 yr receive 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 IU/kg of human rabies immune globulin (HRIG).

5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28 and 90 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

Human Rabies Immune Globulin

Biological

HRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers on day 0

Other names: Human Rabies Immune Globulin produced by Thai Red Cross

Primary outcomes

  1. Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg

    Time frame: Change from baseline of Rabies Neutralizing Antibody Titers at 3 - month period

    Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg would be determined on day 0,14, 28 and 90. Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.

Secondary outcomes

  1. Number of participants who have Rabies Neutralizing antibody titers above protective levels.

    Time frame: Number of participants who have Rabies Neutralizing antibody titers above protective levels at 3-month period..

    Number of participants who have Rabies Neutralizing antibody titers above protective levels (> 0.5 IU/mL as recommended by WHO)at 3-month period.

Sponsors and collaborators

Lead sponsor

Queen Saovabha Memorial Institute

Other

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2012
Registry last updated
Apr 9, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.