NCT03093545

Brief Summary

A single center, prospective cohort, open-label study of rabies post exposure program with equine rabies immunoglobulin (ERIG) and purified chick-embryo cell (PCEC) rabies vaccine in WHO category III exposed patients at Siriraj Hospital, Thailand aims to compare serum RVNA responses between obese (BMI \> 30 kg/m2) and normal weight/underweight (BMI \< 25 kg/m2) and to evaluate adverse events occurring after immunization on days 7, 14 and 28.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

1.6 years

First QC Date

January 24, 2017

Last Update Submit

March 31, 2017

Conditions

Rabies

Keywords

rabiesobeseimmunoglobulinrabies vaccinepost-exposureimmunogenicity

Outcome Measures

Primary Outcomes (3)

  • The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.

    To compare RVNA levels between obese and normal/underweight patients.

    At day 7 prior to vaccination.

  • The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.

    To compare RVNA levels between obese and normal/underweight patients.

    At day 14 prior to vaccination.

  • The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.

    To compare RVNA levels between obese and normal/underweight patients.

    At day 28 prior to vaccination.

Secondary Outcomes (1)

  • Incidence of adverse event

    From day 0 to day 60

Study Arms (2)

Normal BMI or underweight (< 24 Kg/m2)

OTHER
Biological: Equine Rabies ImmunoglobulinBiological: Purified chick-embryo cell rabies vaccine

Obese (BMI > 30 Kg/m2)

EXPERIMENTAL
Biological: Equine Rabies ImmunoglobulinBiological: Purified chick-embryo cell rabies vaccine

Interventions

Equine Rabies ImmunoglobulinBIOLOGICAL

40 IU per kg of body weight of ERIG at Day 0

Also known as: ERIG
Normal BMI or underweight (< 24 Kg/m2)Obese (BMI > 30 Kg/m2)
Purified chick-embryo cell rabies vaccineBIOLOGICAL

1 ml of PCEC Rabies vaccine on days 0, 3, 7, 14 and 28.

Also known as: PCEC
Normal BMI or underweight (< 24 Kg/m2)Obese (BMI > 30 Kg/m2)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female ages of \>= 18 years and older;
  • Experienced WHO category III rabies exposure excluding presenting wound at eye(s) or eye lid(s);
  • Either a) obese with BMI \>= 30 or b) normal weight and/or underweight with BMI \< 25;
  • Agree to independently consent to participate in all study procedures.

You may not qualify if:

  • Positive skin test to ERIG or known hypersensitivity to ERIG or its excipients;
  • Co-enrolment with other studies or participated in other investigational drug studies or use of other investigational drugs within 4 weeks or five times the half-life of the investigational drug;
  • Female patients who are currently pregnant or breast feeding.
  • Presenting with wound at eye(s) or eye lid(s);
  • Receiving rabies vaccination more than 7 days for this exposure;
  • History of complete pre-exposure or post-exposure regimen with at least 3 doses;
  • Known of allergic to egg or poultry meat;
  • History of previous exposure to equine sera
  • Significant illness that might harm or increase the risk to the patients;
  • History of drug abuse or alcoholism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

RabiesObesity

Condition Hierarchy (Ancestors)

Rhabdoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2017

First Posted

March 28, 2017

Study Start

March 1, 2015

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

April 4, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

No plan to provide individual participant data (IPD). However, other researcher could request IPD from principal investigator.

Locations

TH(1)