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Effect of ERIG Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response

Effect of Equine Rabies Immunoglobulin Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03524417
Enrollment
20
Registered
2018-05-14
Start date
2018-04-30
Completion date
2023-12-30
Last updated
2022-04-29

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

Conditions

Rabies

Keywords

Rabies immunoglobulin

Brief summary

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).

Detailed description

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.

Interventions

BIOLOGICALEquine 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.

Sponsors

Queen Saovabha Memorial Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18 - 60 years * WHO category III rabies exposure * Received rabies vaccination on day 0 and 3.

Exclusion criteria

* Received RIG * Immunocompromised hosts or receiving immunosuppressive therapy * Received blood or blood product within 3 months * Received anti-malarial drugs

Design outcomes

Primary

MeasureTime frameDescription
Rabies neutralizing antibody titersChange from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeksRabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs)

Countries

Thailand

Contacts

Primary ContactSuda Sibunruang, MD
sudapunrin@gmail.com+66 2 2520161
Backup ContactTerapong Tantawichien, MD
terapong_tantawichien@hotmail.com+66 2 2520161

Outcome results

None listed

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