Rabies is an acute viral zoonotic disease that is almost universally fatal once clinical manifestations appear; however, it is entirely preventable when appropriate post-exposure prophylaxis (PEP) is initiated promptly following exposure [1,2]. Rabies continues to pose a significant public health challenge in many low- and middle-income countries, particularly across Asia and Africa, with India accounting for a substantial proportion of the global burden of human rabies [1,3]. Dog bites are responsible for nearly all human rabies exposures, making canine-mediated transmission the predominant source of infection worldwide [1]. Despite sustained national rabies control efforts and improved availability of modern cell culture vaccines and passive immunization products, millions of individuals exposed to animal bites require rabies PEP each year, emphasizing the ongoing need for effective preventive strategies [1,2].

Rabies post-exposure prophylaxis comprises immediate and meticulous wound cleansing, administration of anti-rabies vaccine, and passive immunization with rabies immunoglobulin (RIG) or rabies monoclonal antibody (RMAb) for individuals sustaining Category III exposures, in accordance with World Health Organization recommendations [1,2]. Prompt and appropriate administration of these interventions effectively prevents rabies by inhibiting viral progression before involvement of the central nervous system [1]. Modern cell culture rabies vaccines and passive immunization products have consistently demonstrated excellent safety profiles, with adverse events being predominantly mild, transient, and self-limiting. The most frequently reported reactions include pain, erythema, or swelling at the injection site, accompanied occasionally by mild systemic symptoms such as fever, headache, or malaise [2,4].

Although the efficacy of rabies PEP under recommended protocols has been conclusively established, there remains a need for real-world evidence regarding its implementation, safety, and clinical outcomes in routine healthcare practice [2,4]. Information on the sociodemographic characteristics of animal bite victims, patterns of PEP administration, adverse events following immunization, and treatment outcomes is essential for evaluating adherence to standard recommendations and strengthening pharmacovigilance activities.⁴ Such evidence is particularly valuable in countries with a high rabies burden, where large numbers of animal bite victims receive PEP annually [3]. Therefore, the present study was undertaken to describe the sociodemographic profile and characteristics of animal bite victims, document the pattern of rabies post-exposure prophylaxis administered, and evaluate the safety and clinical effectiveness of rabies post-exposure prophylaxis among animal bite victims attending an Anti-Rabies Clinic.

MATERIALS AND METHODS

This prospective observational study was conducted over three months, at the Anti-Rabies Clinic of the Preventive Medicine Unit, Kempegowda Institute of Medical Sciences Hospital and Research Centre, Bengaluru. All consecutive animal bite victims attending the clinic during the study period were screened for eligibility. A total of 312 participants who fulfilled the eligibility criteria and provided written informed consent were enrolled. Approval from the Institutional Ethics Committee was obtained before commencement of the study. Patients presenting with Category III animal exposures and requiring complete rabies post-exposure prophylaxis according to the institutional protocol were included. Individuals who declined consent, did not initiate post-exposure prophylaxis, or had incomplete treatment or follow-up records were excluded.

After obtaining informed consent, information regarding sociodemographic characteristics, the biting animal, site and type of wound, and first-aid measures undertaken before hospital presentation was recorded using a structured case record form. Details of the post-exposure prophylaxis administered were also documented. All participants received standard rabies post-exposure prophylaxis in accordance with the prevailing national and World Health Organization recommendations. Management included immediate and thorough wound washing with soap and running water, administration of anti-rabies vaccine through the intramuscular route, and passive immunization using equine rabies immunoglobulin, human rabies immunoglobulin, or rabies monoclonal antibody, as clinically indicated. Passive immunization was infiltrated into and around the wounds according to the recommended technique. Additional treatment, including tetanus prophylaxis, antibiotics, analgesics, and wound dressing, was provided whenever required.

Participants were prospectively monitored for local and systemic adverse reactions throughout the vaccination schedule up to Day 28. Adverse reactions reported or observed during follow-up visits were documented and managed according to standard clinical practice. The participants were subsequently followed for six months through scheduled telephonic interviews and, when required, home visits. Clinical effectiveness was assessed based on survival and the absence of clinical features suggestive of rabies during the follow-up period.

Categorical variables were summarized using frequencies and percentages. As the study was descriptive in nature and did not involve comparison between treatment groups, no inferential statistical tests were applied. The sociodemographic characteristics, details of animal exposure, pattern of rabies post-exposure prophylaxis, adverse reactions, and six-month clinical outcomes were analysed descriptively. Statistical analysis was performed using IBM SPSS Statistics for Windows, version 27.0 (IBM Corp., Armonk, NY, USA).

RESULTS

Table 1: Sociodemographic characteristics of the study participants (N = 312)

Among the 312 participants, 139 (44.7%) were aged 18–59 years, followed by 96 (30.7%) aged below 18 years and 77 (24.6%) aged 60 years or older. Males constituted the majority, accounting for 215 (68.9%) participants. Regarding education, 83 (26.6%) were graduates or postgraduates and 72 (23.1%) had completed pre-university education. Most participants belonged to the upper-middle 83 (26.6%) or lower-middle 82 (26.3%) socioeconomic classes. (Table 1)

Figure 1: Distribution of study participants according to the biting animal

Figure 2: Distribution of study participants according to the type of dog

Dogs were responsible for the majority of animal exposures, accounting for 292 (93.6%) cases. Other exposures included wild animals in 10 (3.2%), cats in 7 (2.3%), and monkeys in 3 (1.0%) participants. Among the 292 dog-bite cases, 206 (70.5%) involved stray dogs, while 86 (29.5%) were caused by pet dogs. (Figure 1 & 2)

Table 2: Distribution of study participants according to the site and type of bite wound (N = 312)

*Multiple responses were possible for the site of bite; therefore, percentages may exceed 100%.

†Other sites included the head and neck, trunk, and genital region.

Figure 3: First-aid practices adopted before hospital presentation among the study participants (N = 312)

The lower limb was the most commonly affected site, reported in 132 (42.3%) participants, followed by the upper limb in 118 (37.8%). Other sites, including the head and neck, trunk, and genital region, were involved in 82 (26.3%) participants. Abrasions were the most frequent wound type, observed in 143 (45.8%) participants, followed by lacerations in 116 (37.2%) and puncture wounds in 53 (17.0%). (Table 2)

Table 3: Details of rabies post-exposure administered among the study participants (N = 312)

*Multiple additional treatments could be provided to the same participant; therefore, the percentages may exceed 100%.

Rabies monoclonal antibody - Rabishield; Equine rabies immunoglobulin - Equirab; Human rabies immunoglobulin - Berirab-P

Before reporting to the hospital, 261 (83.7%) participants had washed the wound, whereas 51 (16.3%) had not undertaken wound washing. Indigenous substances had been applied to the wound by 37 (11.9%) participants, while 275 (88.1%) reported no such application before seeking medical care. (Figure 3)

All participants received wound washing, wound irrigation, and intramuscular anti-rabies vaccination. Rabivax-S was the most commonly administered vaccine brand, used in 240 (76.9%) participants. Rabies monoclonal antibody was the predominant passive immunization product, administered to 239 (76.6%), and local wound infiltration alone was performed in 292 (93.6%). Antibiotics and tetanus prophylaxis were provided to 240 (76.9%) and 230 (73.7%) participants, respectively. (Table 3)

Table 4: Distribution of local and systemic adverse reactions following rabies post-exposure prophylaxis (N = 312)

*Multiple adverse reactions could occur in the same participant; therefore, the percentages may exceed 100%.

Pain at the administration or infiltration site was the most frequently reported local reaction, occurring in 59 (18.9%) participants, followed by erythema in 51 (16.3%) and itching in 41 (13.1%). Among systemic reactions, headache and myalgia/body ache were each reported in 37 (11.9%) participants. Fever occurred in 31 (9.9%), malaise in 25 (8.0%), and nausea in 15 (4.8%) participants. (Table 4)

Table 5: Six-month clinical outcomes following rabies post-exposure prophylaxis among the study participants (N = 312)

All 312 (100.0%) participants completed the prescribed post-exposure prophylaxis, Day 28 safety follow-up, and six-month clinical follow-up. At six months, every participant remained healthy without clinical features suggestive of rabies. No participant developed clinically suspected rabies, and no rabies-related or all-cause mortality was recorded during the follow-up period. (Table 5)

DISCUSSION

Despite the established effectiveness of rabies post-exposure prophylaxis (PEP), real-world evidence regarding its safety, implementation, and clinical outcomes remains essential, particularly in high-burden settings. This prospective observational study was conducted for 3 months, at the Anti-Rabies Clinic, Kempegowda Institute of Medical Sciences Hospital and Research Centre, Bengaluru, after ethics approval. A total of 312 consecutive Category III animal bite victims who provided written informed consent were enrolled; those who declined consent, did not initiate PEP, or had incomplete treatment or follow-up records were excluded. Sociodemographic details, animal exposure characteristics, wound profile, first-aid practices, and PEP received were recorded using a structured case record form. Participants received standard wound care, intramuscular anti-rabies vaccination, and indicated passive immunization with rabies immunoglobulin or monoclonal antibody. Additional treatment was provided as required. Adverse reactions were monitored until Day 28, and clinical effectiveness was assessed over six months through survival and absence of suspected rabies.

Adults aged 18–59 years constituted the largest proportion of participants in the present study (44.7%; 139/312), followed by those aged <18 years (30.7%; 96/312) and ≥60 years (24.6%; 77/312). Comparable adult predominance was reported by Haradanhalli RS et al. (2016), where 70.5% were aged 14–65 years, and Bahiru A et al. (2026), who observed 50.7% in the 15–45-year age group [5,6]. In contrast, Fotedar N et al. (2025) exclusively evaluated children (mean age: 9.4 years), while Huang S et al. (2019) reported a single pediatric case, indicating that anti-rabies clinics cater to all age groups, although children remain particularly vulnerable [7,8]. A marked male predominance was observed (68.9% males vs. 31.1% females), consistent with Fotedar N et al. (70.9% males), Haradanhalli RS et al. (72.6%), and Bahiru A et al. (70.3%), reflecting greater male involvement in outdoor activities and occupational exposure [7,5,6].

Educational attainment was relatively high, with graduates/postgraduates comprising 26.6% and illiterates only 5.4%. Bahiru A et al. reported formal education in 67.4% but illiteracy/informal education in 32.6%, whereas Fotedar N et al. described 43.0% of participants as school-going children [6,7]. Socioeconomically, the upper-middle (26.6%) and lower-middle (26.3%) classes predominated. Fotedar N et al. similarly reported a predominantly middle-class cohort (67.8%), whereas Nadal D et al. (2023) and Bahiru A et al. highlighted that the greatest rabies burden and mortality occur among socioeconomically disadvantaged rural populations with limited healthcare access [7,9,6].

Dogs were the predominant source of exposure in the present study, accounting for 93.6% (292/312) of cases, followed by wild animals (3.2%), cats (2.3%), and monkeys (1.0%). Similar findings were reported by Fotedar N et al. (2025), with 96.6% dog bites, and Haradanhalli RS et al. (2016), with 79.2% dog bites [7,5]. Bahiru A et al. (2026) further highlighted that domestic dogs are responsible for approximately 99.0% of human rabies infections globally [6]. Among dog-bite cases, stray dogs accounted for 70.5% of exposures compared with 29.5% from pet dogs, a higher proportion than reported by Fotedar N et al. (48.8% stray) and Bahiru A et al. (56.5% stray), emphasizing the importance of controlling both stray and inadequately managed owned dogs [7,6].

The lower limb was the most commonly affected site (42.3%), followed by the upper limb (37.8%). Comparable distributions were observed by Fotedar N et al. (42.2% and 35.3%, respectively) and Haradanhalli RS et al. (44.2% and 42.1%), while Bahiru A et al. reported leg involvement in 50.7% [7,5,6]. Lower-limb predominance likely reflects easier anatomical accessibility, whereas bites involving the head, neck, and hands require urgent management because of their higher risk. Abrasions were the commonest wound type (45.8%), followed by lacerations (37.2%) and puncture wounds (17.0%). Fotedar N et al. reported a similar distribution with abrasions (44.6%), whereas Haradanhalli RS et al. found lacerations (47.4%) to be most frequent [7,5]. Bahiru A et al. observed that 89.1% of fatal rabies cases had Category III wounds, and Nadal D et al. (2023) emphasized that such wounds require immediate rabies immunoglobulin and post-exposure prophylaxis, highlighting the greater clinical significance of deep lacerations and puncture wounds [6,9].

In the present study, 83.7% (261/312) of participants had washed their wounds before reaching the hospital, while 16.3% (51/312) had not. Haradanhalli RS et al. (2016) reported a considerably lower wound-washing rate of 57.9% (55/95), whereas Bahiru A et al. (2026) observed that many rural patients neglected wound cleansing and instead relied on traditional remedies [5,6]. Nadal D et al. (2023) emphasized that immediate washing with soap and running water for approximately 15 minutes is the most effective first-aid measure to reduce viral inoculum. Indigenous substances were applied by 11.9% (37/312) of participants in the present study[9]. Nadal D et al. discouraged such practices because of contamination risks, while Bahiru A et al. reported widespread use of traditional plant remedies in rural Ethiopia, often delaying timely post-exposure prophylaxis (PEP) [9,6]. At the anti-rabies clinic, 100% (312/312) of participants underwent professional wound washing and irrigation, while 20.5% (64/312) required wound dressing. Nadal D et al. recommended thorough wound cleansing with antiseptics and avoidance of primary suturing whenever possible, whereas Bahiru A et al. highlighted inadequate wound-care facilities in resource-limited rural settings [9,6].

All participants (100%; 312/312) received anti-rabies vaccination using the intramuscular Essen regimen. Rabivax-S was administered to 76.9% (240/312), Abhayrab to 8.0% (25/312), and Vaxirab-N to 3.5% (11/312). Similarly, Fotedar N et al. (2025) used the Essen regimen, administering purified Vero cell vaccine to 65.1% (188/289) and purified chick embryo cell vaccine to 34.9% (101/289), while Haradanhalli RS et al. (2016) predominantly used purified chick embryo cell vaccine (81.1%; 77/95) [7,5]. Huang S et al. (2019) reported successful substitution of purified Vero cell vaccine after anaphylaxis to human diploid cell vaccine [8]. In contrast, Nadal D et al. advocated the WHO one-week intradermal regimen to improve cost-effectiveness, whereas Bahiru A et al. described continued use of obsolete nerve-tissue vaccines in rural Ethiopia [9,6]. For passive immunization, rabies monoclonal antibodies were used in 76.6% (239/312), equine rabies immunoglobulin in 22.1% (69/312), and human rabies immunoglobulin in 1.3% (4/312). Comparable findings were reported by Fotedar N et al., with monoclonal antibodies in 67.1% (194/289) and equine rabies immunoglobulin in 10.0% (29/289) [7]. Haradanhalli RS et al. reported exclusive use of equine (93.7%) and human (6.3%) rabies immunoglobulins, reflecting practice before monoclonal antibodies became widely available [5]. Bahiru A et al. noted complete unavailability of passive immunization products in rural Ethiopia, while Nadal D et al. endorsed monoclonal antibodies as safe and scalable alternatives [6,9]. Local infiltration into and around the wound alone was performed in 93.6% (292/312), whereas 6.4% (20/312) required additional systemic administration. Similar proportions were reported by Fotedar N et al. (92.7% local infiltration alone) and Haradanhalli RS et al. (86.2%) [7,5]. Nadal D et al. emphasized that adequate local wound infiltration is the cornerstone of passive immunization, with minimal benefit from unnecessary systemic administration [9].

Local adverse reactions following post-exposure prophylaxis (PEP) were generally mild and self-limiting in the present study. Pain at the injection or infiltration site was the most common local reaction, occurring in 18.9% (59/312) of participants, followed by erythema (16.3%; 51/312), itching (13.1%; 41/312), and localized swelling (6.7%; 21/312). Similar findings were reported by Fotedar N et al. (2025), who observed pain in 13.1% (38/289), erythema in 7.6% (22/289), itching in 6.2% (18/289), and swelling in 5.9% (17/289) [7]. Haradanhalli RS et al. (2016) reported a lower overall incidence of local adverse events (7.5%), including pain (2.5%), itching (2.3%), erythema (2.1%), and induration (0.6%) [5]. Huang S et al. (2019) described a rare severe injection-site swelling following human diploid cell vaccine, suggesting that serious local reactions are uncommon with modern vaccines [8].

Systemic adverse events were also infrequent and transient. Headache and myalgia/body ache each occurred in 11.9% (37/312), followed by fever (9.9%; 31/312), malaise (8.0%; 25/312), and nausea (4.8%; 15/312). Fotedar N et al. reported lower frequencies of body ache (5.2%), fever (3.5%), and malaise (1.7%), while Haradanhalli RS et al. documented no systemic adverse reactions [7,5]. Huang S et al. reported an isolated case of acute anaphylaxis in a two-year-old child, whereas Bahiru A et al. (2026) highlighted that obsolete nerve-tissue vaccines are associated with frequent systemic and neurological adverse effects [8,6]. These findings support the favorable safety profile of modern cell-culture vaccines.

All participants (100%; 312/312) completed the prescribed PEP schedule and Day-28 follow-up. At six months, 100% remained healthy, with 0% clinically suspected rabies, 0% rabies-related mortality, and 0% all-cause mortality. Comparable outcomes were reported by Fotedar N et al., with 100% survival among 289 children, and Haradanhalli RS et al., where all 95 participants remained healthy one year after PEP [7,5]. In contrast, Bahiru A et al. reported that only 65.2% (90/138) received post-exposure vaccination, resulting in 46 rabies deaths, largely due to delayed treatment and reliance on traditional remedies [6]. Their multivariable analysis demonstrated that PEP reduced the risk of rabies death by 94.2% (AOR=0.058; p=0.001), while each day of treatment delay increased mortality risk by 15% (AOR=1.15; p=0.002).

Supportive care in the present study was comprehensive, with antibiotics administered to 76.9% (240/312), tetanus prophylaxis to 73.7% (230/312), analgesics to 41.7% (130/312), and wound dressing to 20.5% (64/312). Nadal D et al. (2023) similarly recommended tetanus prophylaxis, antibiotics for contaminated wounds, meticulous wound care, and prompt passive immunization [9]. Overall, the present findings closely align with those of Fotedar N et al., Haradanhalli RS et al., and Nadal D et al., confirming that standardized wound management, modern cell-culture vaccines, and appropriate passive immunization are safe, well tolerated, and highly effective in preventing human rabies [7,5,9]. Differences compared with Bahiru A et al. primarily reflect disparities in healthcare access, vaccine availability, and delays in treatment in resource-limited settings [6].

CONCLUSION

The study demonstrated that complete rabies post-exposure prophylaxis, comprising appropriate wound care, anti-rabies vaccination and passive immunization, was safe, well tolerated and clinically effective among Category III animal bite victims. Adverse reactions were mild and predominantly local or transient systemic symptoms. All participants completed treatment and follow-up, and none developed suspected rabies or died during six months of observation. These findings support the timely and appropriate administration of complete post-exposure prophylaxis as an effective strategy for preventing rabies following animal bites.

Acknowledgement: We sincerely thank the faculty of the institute for helping us in each aspect of the study.

Funding: None

Conflict of interest: None declared

REFERENCES

1. World Health Organization. Rabies [Internet]. Geneva: World Health Organization; 2024 Jun 5 [cited 2026 Jul 20]. Available from: https://www.who.int/news-room/fact-sheets/detail/rabies
2. World Health Organization. Rabies vaccines: WHO position paper – April 2018. Wkly Epidemiol Rec. 2018;93(16):201-20.
3. World Health Organization. Rabies in India [Internet]. New Delhi: WHO Country Office for India [cited 2026 Jul 20]. Available from: https://www.who.int/india/health-topics/rabies
4. Manning SE, Rupprecht CE, Fishbein D, Hanlon CA, Lumlertdacha B, Guerra M, et al. Human rabies prevention—United States, 2008: Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2008;57(RR-3):1-28.
5. Haradanhalli RS, Krishna C, Kumar DP, Siddareddy I, Annadani RR. Safety, immunogenicity and clinical efficacy of post exposure prophylaxis in confirmed rabies exposures. Global Vaccines and Immunology. 2016;1(3):56-9.
6. Bahiru A, Mekonnen SA, Yizengaw L, Kenubih A, Aklog W, Walle Y, et al. Rabies Post Exposure Vaccine Effectiveness: A Retrospective Case–Control Study in Amhara Region, Ethiopia. Scientifica. 2026;2026:9307457.
7. Fotedar N, Ravish HS. A prospective study on safety and clinical efficacy of rabies biologicals in paediatric patients with category III animal exposure. Clinical and Experimental Vaccine Research. 2025 Jan;14(1):59-66.
8. Huang S, Zhu Z, Cai L, Zhu Z, Zhang M, Hu Q, et al. Analysis on the risks of severe adverse events in rabies post-exposure prophylaxis and appropriate decision-making procedure. Human Vaccines & Immunotherapeutics. 2019;15(9):2121–5.
9. Nadal D, Bote K, Masthi R, Narayana A, Ross Y, Wallace R, et al. Rabies post-exposure prophylaxis delivery to ensure treatment efficacy and increase compliance. IJID One Health. 2023;1:100006.