Effect of ERIG Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response
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|ClinicalTrials.gov Identifier: NCT03524417|
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : May 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rabies||Biological: Equine rabies immunoglobulin injection on day 7||Not Applicable|
Rabies immunoglobulin (RIG) should be administered as soon as possible after the initiation of post-exposure prophylaxis. RIG should not be given after day 7 following the first rabies vaccine dose, because circulating neutralizing antibody will have begun to appear. Nevertheless, no study was conducted to evaluate the rabies neutralizing antibody titers after RIG injection on day 7.
The only study that has supported the delay of RIG administration was done in 1996 by our institute, of which RIG was given on day 5 with the original Thai Red Cross intradermal regimen (2-2-2-0-1-1). The ongoing study would prove the validity of the recommendation and eliminate the controversies in clinical practice.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Equine Rabies Immunoglobulin Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response|
|Actual Study Start Date :||April 30, 2018|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Experimental: RIG injection
RIG injection on day 7
Biological: Equine rabies immunoglobulin injection on day 7
The patients with WHO category III rabies exposure, who have received first dose of rabies vaccination a week before and have not received rabies immunoglobulin were enrolled. Blood for Rabies neutralizing antibody titers (RNab) would be examined on day 0. On the same day, Equine rabies immunoglobulin (ERIG) at the dosage of 40 IU/kg would be injected into and around the wound as much as possible and the rest would be injected intramuscularly at the site distance from rabies vaccine. Then blood for RNab would be serially examined on day 7, 14, 90, 365.
- Rabies neutralizing antibody titers [ Time Frame: Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks ]Rabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524417
|Contact: Suda Sibunruang, MD||+66 2 2520161 ext firstname.lastname@example.org|
|Contact: Terapong Tantawichien, MD||+66 2 2520161 ext email@example.com|
|Queen Saovabha Memorial Institute, Thai Red Cross Society||Recruiting|
|Bangkok, Thailand, 10330|
|Contact: Suda Sibunruang, M.D. +66 81 7366076 firstname.lastname@example.org|
|Contact: Terapong Tantawichien, M.D. +66 2 2520161 ext 125 email@example.com|
|Principal Investigator: Suda Sibunruang, M.D.|
|Principal Investigator:||Suda Sibunruang, MD||Queen Saovabha Memorial Institute|