A multicentric community survey on animal exposures among humans in India.

BACKGROUND: Rabies is a 100% fatal disease. There are inadequate data on animal exposures and rabies postexposure prophylaxis (PEP) from community-based field surveys in India. OBJECTIVES: : The main objective of the study is to estimate the incidence of animal exposures (bite, scratch, or lick) in the study population and to describe the rabies PEP among the cases. METHODS: A descriptive survey was conducted in seven states of India between July and November, 2017. In each state, multistage sampling methodology was followed for selection of district, taluka/tehsil, block, and clusters within the block. The primary sampling unit was a household (HH). A case was a patient with animal exposure (bite, scratch, or lick) in the last 1 year from the date of survey. The animal exposure was categorized based on the WHO guidelines (Category-I, Category-II, and Category-III). The patients with the history of multiple animal exposures any time during the survey period was considered as a single case. RESULTS: A total of 1012 HHs were surveyed covering a population of 4294. 3016 (70.2%) participants were from rural settings and 1278 (29.8%) were living in urban settings. 2181 (50.8%) participants were male and 2113 (49.2%) were female. The annual incidence of animal exposure was 1.26% (confidence interval [CI]: 0.93%-1.59%). The annual incidence in urban setting was 1.33% (0.70 - 1.96) and rural settings were 1.23% (CI: 0.84 - 1.62). Majority (68.5%) of the cases were from rural settings, 61.2% of the cases were in the age group of 15-60 years. Among the 43 cases who had received PEP, 21 had Category-II exposures, of whom 66.7% had completed vaccination with either five doses intramuscular or four doses intradermal route. Similarly, 22 had Category-III exposures and only 4 (18.2%) cases had received rabies immunoglobulin and completed rabies vaccination. Six ( 11.1%) cases did not receive PEP. There was no report of human rabies case. CONCLUSION: The incidence of animal exposure was 1.26%. Rabies PEP in the cases was not satisfactory.

Health-seeking behavior and compliance to post exposure prophylaxis among animal bite victims in India.

BACKGROUND: In rabies endemic countries, where every animal bite is potentially a suspected rabid exposure, the exposed individuals should seek early and proper health care. It is also essential to complete the full course of postexposure vaccination to protect against rabies. OBJECTIVES: The study aimed at determining the health-seeking behavior of animal bite victims; assessing the perceived risk of rabies transmission from different animals and knowledge on its prevention and finding out the compliance to complete course of rabies vaccination and associated factors. METHODS: A multi-centric, health facility-based survey was conducted during May 2017 to January 2018 in six regional-representative states involving 18 health facilities. Study participants were animal bite victims attending the health facilities. The data from all the study participants across the country were compiled and analyzed using descriptive statistics and Chi-square test to find out the association of factors influencing compliance. RESULTS: Among a total of 529 animal bite victims, 83.6% sought postexposure prophylaxis coming directly to health facility; others visited nonallopathic/traditional healers/veterinarians/Auxiliary Nursing Midwifery before coming to health facility. The perceived risk of disease transmission and knowledge on the prevention of rabies was insufficient among the exposed victims. All participants were started with anti-rabies vaccination; the compliance rate for the full course of intramuscular rabies vaccination was 65.9% and for intra-dermal rabies vaccination, it was 85.1%. Among Category III exposures, only 46.2% received rabies immunoglobulin. CONCLUSIONS: Health-seeking behavior and compliance to complete course of anti-rabies vaccination is unsatisfactory, which has to be improved to prevent rabies.

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.

An immunogenicity, safety and post-marketing surveillance of a novel adsorbed human diploid cell rabies vaccine (Rabivax) in Indian subjects.

In 1999, Serum Institute of India indigenously developed an adsorbed human diploid cell rabies vaccine (Rabivax). During 2000-04, this new vaccine was subjected to a series of immunogenecity and safety studies. Initially, an experimental batch of Rabivax (adsorbed) was assessed on ten healthy adult volunteers and its response was comparable with that of Merieux inactivated rabies vaccine (MIRV, lyophilized) which was used as a control. Subsequently, Rabivax (adsorbed) was assessed on forty-five suspect rabid dog bite cases with MIRV as control. The vaccine was found to be equally safe and immunogenic as MIRV and showed better rabies virus neutralizing antibody (RVNA) response on day 90 than MIRV. A post-licensing study conducted on 150 cases of suspect rabid animal bites showed it to be safe and immunogenic. To assess its long-term sero-efficacy some of these subjects tested after one year of follow up showed that 84% of them had adequate RVNA titers. In addition, a routine post-marketing surveillance done on 1608 animal bite cases demonstrated that Rabivax (adsorbed) was safe and efficacious. The adverse events to Rabivax (adsorbed) included pain at injection site (3.4%), swelling with induration (2.8%), fever and headache (1.4%). No serious adverse event was reported from the studies. In conclusion, Rabivax (adsorbed) is an immunogenic, safe and efficacious vaccine for rabies prophylaxis in humans.

A comparative study on the immunogenicity, safety and tolerance of purified duck embryo vaccine (PDEV) manufactured in India (Vaxirab) and Switzerland (Lyssavac-N): a randomized simulated post-exposure study in healthy volunteers.

Purified duck embryo vaccine (PDEV, Vaxirab) for rabies prophylaxis is now indigenously manufactured in India under technology transfer from Berna Biotech who made the original PDEV (Lyssavac). In the present study we have compared the two vaccines in terms of safety, immunogenicity and tolerance. The study was conducted in 220 adult healthy volunteers. It was observed that both vaccines produced neutralizing antibody titers (as determined by rapid fluorescent focus inhibition test, RFFIT) more than 0.5 IU/mL (minimum level for seroconversion) on all days tested but the titers on days 90 and 180 were significantly higher with Lyssavac. The adverse reactions produced were slightly more with Lysssavac but both vaccines were well tolerated. In conclusion, the indigenously produced PDEV (Vaxirab) was found to be equally safe and immunogenic as the original PDEV (Lyssavac) manufactured at Switzerland.