Safety and immunogenicity of rabies vaccine as 4 - dose Essen Intramuscular regimen for post exposure prophylaxis: A non - randomized, comparative controlled study.

Introduction

World Health Organization has recommended that in healthy persons with category III exposures, who receive wound care and rabies immunoglobulin infiltration, a vaccine regimen consisting of 4 doses administered intramuscularly on days 0, 3, 7, and 14 can be used as an alternative to the 5-dose intramuscular regimen.

Objective

To assess the clinical safety and immunogenicity of rabies vaccine administered as 4-dose Essen intramuscular regimen for post-exposure prophylaxis.

Methods

A non-randomized, comparative, controlled study was conducted at the anti-rabies clinic, KIMS Hospital and Research Center, Bangalore, India. The study subjects were divided into study group i.e., 4-dose intramuscular regimen, and control group i.e., 5-dose intramuscular regimen, and were given post-exposure prophylaxis. All subjects were followed for any adverse drug events. Rabies virus neutralizing antibodies was determined on day 14, 90 & 180 at the WHO collaborating center, NIMHANS, Bangalore, India to assess the immunogenicity.

Results

The present study included 70 adult animal bite victims, 35 each in study group and control group. The incidence of ADEs was 7.8% in 4-dose Essen group and 7.0% in 5-dose Essen group;the difference between them was not significant (P > .05). Similarly, all the subjects in both the groups had protective antibody titers of ≥ 0.5 IU/mL (100% seroprotective) from day 14 till day 180; the difference between two groups was also not significant (P > .05).

Conclusion

The 4-dose intramuscular Essen post-exposure prophylaxis regimen was found to be clinically safe and immunogenic.