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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
40 IU per kg of body weight of ERIG at Day 0
1 ml of PCEC Rabies vaccine on days 0, 3, 7, 14 and 28.
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Bangkok, Thailand
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.
Time frame: 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.
Time frame: 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.
Time frame: At day 28 prior to vaccination.
Incidence of adverse event
Number of participants with ERIG or PCEC-related adverse events as assessed by investigator as per CTCAE v4.03.
Time frame: From day 0 to day 60
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