
==== Front
Int J Appl Basic Med Res
Int J Appl Basic Med Res
IJABMR
Int J App Basic Med Res
International Journal of Applied and Basic Medical Research
2229-516X
2248-9606
Wolters Kluwer - Medknow India

IJABMR-14-193
10.4103/ijabmr.ijabmr_281_24
Original Article
Assessing the Safety of a Novel Monoclonal Antibody Cocktail for Postexposure Prophylaxis in Category III Animal Exposures
Singh Amandev
Sibia Raminderpal Singh 1
Oberoi Simmi
Bhatia Lovleen 1
Kaushal Sachin 1
Dutta Trayambak 2
Mahajan Manish 2
Desai Samir 2
Department of Community Medicine, Government Medical College, Patiala, Punjab, India
1 Department of Medicine, Government Medical College, Patiala, Punjab, India
2 Zydus Lifesciences Limited, Ahmedabad, Gujarat, India
Address for correspondence: Dr. Trayambak Dutta, Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Near Vaishnodevi Circle, S. G. Highway, Ahmedabad - 382 481, Gujarat, India. E-mail: trayambak.dutta@zyduslife.com
Jul-Sep 2024
24 8 2024
14 3 193198
13 6 2024
02 8 2024
12 8 2024
Copyright: © 2024 International Journal of Applied and Basic Medical Research
2024
https://creativecommons.org/licenses/by-nc-sa/4.0/ This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
Background:

TwinRab™ is a novel life-saving biological containing two monoclonal antibodies (docaravimab and miromavimab) essential for all age victims of category III animal exposures. It effectively neutralizes rabies and similar viruses at the exposure site until the body generates vaccine-induced antibodies. This postmarketing surveillance study assesses the safety of TwinRab™ in current postexposure prophylaxis (PEP) use and aims to reinforce its safety data for future applications.

Methods:

The prospective, open-label observational study was conducted on patients with the World Health Organization category III animal exposures at a government hospital in a northern region of India, by a suspected rabid animal. The study protocol included administering TwinRab™ (40 IU/kg) and a full course of anti-rabies vaccination as PEP.

Results:

Out of 405 participants, 404 completed the study as per the protocol. Adverse events (AEs) occurred in 12.35% of cases, with 9.88% local AEs (primarily pain and tenderness) and 2.47% systemic AEs (fever, malaise, and myalgia). All AEs were mild and resolved without complications. Most participants (88.9%) and investigators (89.1%) rated TwinRab™’s tolerability as excellent.

Conclusion:

The present study demonstrates the evidence of a satisfactory safety profile along with better tolerability of TwinRab™ (40 IU/kg) for category III animal exposures and supports its continued usage.

Category III animal exposures
postexposure prophylaxis
rabies
safety
TwinRab™
==== Body
pmcIntroduction

Rabies is a significant global public health concern, with an estimated 59,000 annual human deaths worldwide, of which approximately 35% occurs in India. This zoonotic disease is primarily transmitted to humans through the bite of infected animals, with dogs being the primary source of infection in India, accounting for 95%–97% of rabies cases.[1] The annual estimated number of dog bites in India is 17.4 million, leading to an estimated 18,000–20,000 cases of human rabies per year. In India, rabies is a major public health concern, with the country accounting for a significant portion of global rabies deaths.[2] According to the World Health Organization (WHO), India accounts for 36% of the global deaths due to rabies, and 65%of the deaths due to rabies in the Southeast Asia region. The National Rabies Control Program reported 6644 clinically suspected cases and deaths of human rabies between 2012 and 2022 in India. The disease has claimed the lives of 18 people in the state of Tamil Nadu in the last 8 months alone, highlighting the severity of the crisis.[34]

Postexposure prophylaxis (PEP) is the cornerstone of preventing rabies in individuals who have been exposed to the virus. Traditional PEP involves the administration of rabies vaccines, and in some cases, rabies immunoglobulin (RIG) to neutralize the virus and prevent its spread within the body. However, traditional RIG faces challenges such as high cost, limited availability, and the requirement for meticulous wound management, posing barriers to effective rabies treatment, especially in resource-constrained settings.[5]

Monoclonal antibody (mAb) cocktails have emerged as a promising alternative to traditional RIG for rabies PEP. These cocktails consist of a combination of mAbs that target different epitopes of the rabies virus, providing a broader and more potent neutralizing effect.[6] TwinRab™ is a novel cocktail of mAbs, specifically docaravimab and miromavimab, designed to address the challenges associated with traditional RIG in preventing rabies infection. By binding to specific epitopes within the rabies virus glycoproteins, TwinRab™ offers a robust protective mechanism against the virus, even in the presence of mutations.[7]

TwinRab™ functions by binding to two distinct antigenic sites on the rabies virus glycoproteins, ensuring comprehensive protection against the virus. This dual-binding approach enhances the neutralizing capacity of TwinRab™, making it a reliable option for individuals exposed to rabies.[8] The WHO has endorsed TwinRab™ for PEP in suspected rabies cases, underscoring its efficacy and safety profile. Furthermore, regulatory bodies such as the Indian Academy of Paediatrics Advisory Committee on Vaccines and Immunization Practices and the Asia Pacific Conference on Rabies and Immunization have approved TwinRab™, further validating its role in rabies management.[9]

The present study conducted in a government hospital in a northern region of India, focusing on a subset of 405 patients from a larger cohort, aims to enhance the understanding of mAb cocktails like TwinRab™ in treating rabies. By building on data from 615 patients in previous multicenter clinical studies, this research endeavor seeks to provide valuable insights into the safety and effectiveness of TwinRab™ in real-world settings. Rabies is a significant public health concern, particularly in developing countries like India. The development and implementation of effective treatment strategies are crucial. The present study contributes to this global effort by advancing the understanding of mAb cocktails like TwinRab™, ultimately working toward reducing the burden of rabies and improving patient outcomes.

In this study, an open-label postmarketing surveillance clinical trial was conducted to specifically evaluate the safety and tolerability of TwinRab™ in the PEP regimen for patients with suspected WHO category III rabies exposures, crossing all age groups. This investigation is particularly significant as it provides crucial evidence to support the use of mAb cocktails as a viable alternative to traditional RIG for rabies PEP.

Methods

Study design

This open-label postmarketing surveillance study aimed to assess the safety of the mAb cocktail docaravimab and miromavimab (TwinRab™) in combination with anti-rabies vaccines (ARV) in patients who experienced category III animal bites at a government hospital in a northern region of India. The study adhered to the principles outlined in the Declaration of Helsinki and its subsequent revisions, as well as good clinical practice guidelines and other relevant local regulatory standards.

Participants

A total of 405 healthy patients aged 2 years and older, with no prior administration of anti-rabies vaccine or history of animal bites, were enrolled. Eligible patients, both male and female, who experienced WHO category III exposure (s) by a suspected rabid animal within 72 h before enrolment, or within 24 h if the exposure occurred on the face, neck, hand, or fingers, were included. Treatment with the TwinRab™ was initiated at the discretion of the principal investigator. Patients with a history of clinically significant diseases, thrombocytopenia, bleeding disorders, major congenital defects, or serious chronic illnesses also patients who had participated in any other clinical study within the last 30 days were excluded from the study. Written informed consent was obtained from all patients before enrolment. For minors aged 2–17 years, assent forms were obtained from the patients themselves, along with legally authorized representative forms from their parents or guardians. Patients had the freedom to withdraw from the study at any time without affecting their relationship with their study doctor.

Study vaccines and postexposure prophylaxis

PEP was provided to all study participants according to national guidelines, which included a thorough wound wash with soap and running water for 10–15 min, irrespective of any wound care given before presentation to the hospital. Each eligible patient was allocated to receive the cocktail of monoclonal anti-rabies antibodies (docaravimab and miromavimab) on day 0 along with anti-rabies vaccines (ARVs). ARV injections were administered by the intradermal (ID) route, following the updated Thai Red Cross schedule (one dose each on days 0, 3, 7, and 28). The vaccination was performed by trained medical site study personnel. Simultaneous infiltration of TwinRab™ (depending on wound size) was done on day 0, in a single dose of 40 IU/kg body weight into all the wounds, as was anatomically feasible, i.e. until it oozes out of the bite wound/wounds, indicating a successful infiltration. Routine general and systemic examination was also performed on days 0, 3, 7, and 28. The remaining volume of TwinRab™ was injected intramuscularly at a separate site from the ARV injection site. TwinRab™ is manufactured by Zydus Life Sciences Ltd. (Ahmedabad, Gujarat, India).

Ethical statement

The present study conducted complied with the Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments involving humans. It was registered in the Clinical Trials Registry of India (CTRI) on November 2, 2022, with registration number CTRI/2022/11/046994. Approval was obtained from the institutional ethics committee under reference number Trg. 9 (310) 2022 dated November 25, 2022.

Outcome

The study aimed to assess all adverse events (AEs) that occurred from day 0 to 7 days following the final dose of the PEP regimen for rabies, focusing on overall tolerability and causality assessment. Tolerability was evaluated based on the severity of AEs reported by the patients and observed by the investigators, and categorized as follows: Excellent (no AEs or very mild events not affecting daily activities), good (mild AEs causing minimal interference with daily activities), fair (moderate AEs causing noticeable interference with daily activities), and poor (severe AEs causing significant interference with daily activities or requiring medical intervention). The causality assessment was conducted using the WHO criteria, which classify the relationship between the intervention and the AE into six categories: certain (a clinical event occurring in a plausible time relationship to drug administration without an alternative explanation), probable/likely (a clinical event with a reasonable time sequence to drug administration, unlikely attributed to other factors), possible (a clinical event with a reasonable time sequence that could also be explained by other factors), unlikely (a clinical event with a temporal relationship making a causal relationship improbable), conditional/unclassified (a clinical event reported as an adverse reaction needing more data for proper assessment), and unassessable/unclassifiable (an adverse reaction report that cannot be judged due to insufficient or contradictory information).

Safety assessment

The safety of the TwinRab™ was assessed by recording AEs occurring during the study. All abnormalities found in clinical examination were noted as AEs. Solicited (injection site and systemic) AEs were recorded for 7 days postvaccination, and unsolicited (other) AEs were recorded for 35 days (+7 days) following vaccination. Overall tolerability (excellent, good, fair, and poor) of TwinRab™ was assessed by study participants and investigators at the end of therapy.

Data analysis

An electronic data capturing system was utilized to transition patients’ data from physical case report forms (CRFs) to electronic CRFs, enabling efficient and accurate data collection, storage, and management. Subsequently, statistical analysis was conducted using SAS®, version 9.4 (SAS Institute Inc., USA). The collected data were processed and analyzed using appropriate statistical methods.

Statistical analyses

Involved in the generation of associated tables, listings, and figures to summarize and present the study’s findings.

Results

Disposition of participants

A total of 405 consented patients enrolled in the study using a convenience sampling method received TwinRab™ along with ARV. Of these, 404 patients (99.7%) completed the study, while one patient was prematurely terminated due to loss of follow-up. This high completion rate demonstrates excellent adherence to the treatment regimen among the participants.

Demographic and baseline characteristics

Overall, the mean age was 34.0 (±17.90) years (males: 72.8% [n = 295]; females: 27.2% [n = 110]). Upon physical examination by the investigator, all study participants were found normal, and vitals were found within the normal range at the time of recruitment. Majority of study participants were adults (≥18 and ≤65 years; 76.1%) followed by children (aged ≤12 years; 12.1%), adolescents (≥13 and ≤17 years; 6.4%), and geriatric population (aged >65 years; 5.4%). In all age groups, study participants were mostly bitten by dogs (96.8%). The bites in the study participants were mostly present on the lower part of the body (75.3%) and the remaining were present on the upper part of the body (24.7%). Bites were mainly present on legs (51.4%) and feet (12.6%) in lower parts of the body whereas bites were present on hands (9.9%), fingers (7.4%), and upper arms (7.2%) in upper parts of the body. Most of the study participants (99%) had one or more transdermal animal bites whereas 1% of study participants had single or multiple transdermal scratches. The study participants were administered with TwinRab™ within the dose range of 320–4400 IU (40 IU/kg). All study participants were administered with anti-rabies vaccine as per the updated Thai Red Cross Regimen. The details of demographics and baseline characteristics and age-group-wise distribution of study participants for biting animals, bite location and the study vaccine exposures were summarized in Tables 1 and 2.

Table 1 Demographics and baseline characteristics of study participants

Characteristics	TwinRab™ (n=405)	
Gender, n (%)		
 Male	295 (72.8)	
 Female	110 (27.2)	
Age group (years), n (%)		
 Child (<5)	7 (1.73)	
 Child (≥5 and ≤12)	42 (10.37)	
 Adolescent (≥13 and ≤17)	26 (6.42)	
 Adult (≥18 and ≤65)	308 (76.05)	
 Geriatric (>65)	22 (5.43)	
Age (years), mean±SD	34.0±17.90	
Weight (kg), mean±SD	61.3±19.35	
Height (kg), mean±SD	161.7±19.03	
Respiratory rate (beats/min), mean±SD	17.7±3.14	
Systolic blood pressure (mmHg), mean±SD	122.0±6.75	
Diastolic blood pressure (mmHg), mean±SD	79.7±5.17	
SD: Standard deviation

Table 2 Age-group-wise distribution of study participants for biting animals, bite location, and the study vaccine exposures

Age groups	<5 years (n=7; 1.73%)	≥5 and ≤12 years (n=42; 10.37%)	≥13 and ≤17 years (n=26; 6.42%)	≥18 and ≤65 years (n=308; 76.05%)	>65 years (n=22; 5.43%)	
Biting animal, n (%)						
 Dog	7 (100)	40 (95.24)	24 (92.31)	299 (97.08)	22 (100)	
 Cat	0	1 (2.38)	0	4 (1.30)	0	
 Bat	0	0	0	2 (0.65)	0	
 Monkey	0	1 (2.38)	2 (7.69)	3 (0.97)	0	
 Mongoose	0	0	0	2 (0.65)	0	
Bite location on the body, n (%)						
 Lower body	3 (42.86)	29 (69.05)	16 (61.54)	238 (77.27)	19 (86.36)	
 Upper body	5 (71.43)	15 (35.71)	12 (46.15)	76 (24.68)	3 (13.64)	
Study vaccines						
 Time of TwinRab™ administration since exposure (h), mean±SD	12:41±3:20	12:24±2:25	12:02±1:08	12:09±2:13	12:10±1:33	
 Dose (IU) of TwinRab™ administration, mean±SD	456.0±118.1	1091.0±495.3	1944.0±511.3	2705.5±526.5	2711.1±556.6	
 ARV used (updated Thai Red Cross regimen), n (%)	7 (100)	42 (100)	26 (100)	308 (100)	22 (100)	
ARV: Anti-rabies vaccines; SD: Standard deviation

Safety outcome

A total of 63 AEs were reported in 50 (12.35%) patients treated with TwinRab™. Among these patients, 2 (28.6%) patients were children (<5 years), 7 (16.7%) patients were children (≥5 and ≤12 years), 3 (11.5%) patients were adolescent (≥13 and ≤17 years), 35 (11.36%) patients were adults (≥18 and ≤65 years), and 3 (13.6%) patients were geriatric (>65 years). Among these reported AEs, 53 events (84.1%) were local AEs in 40 patients whereas 10 (15.9%) events were systemic AEs in 10 study participants. Forty-one patients (10.12%) were administered with mediation for the treatment of AEs. The majority of local AEs (98.1%) were resolved before the end of the study visit of the study participant. All reported AEs have no relationship with the study vaccines. The study reported common local AEs were pain (9.63%), tenderness (2.72%), erythema (0.25%), swelling (0.25%), and induration (0.25%) whereas reported systemic AEs were myalgia (0.99%), malaise (1.23%), and fever (0.25%). All systemic AEs were reported in adults study participants. There were no serious AEs (SAEs) or treatment-emergent AEs leading to study termination or subject withdrawal from the study. None of the patients have been reported with unsolicited AEs during the study. The summary of recorded AEs during the study and age-group-wise distribution of local and systemic solicited AEs is described in Tables 3 and 4.

Table 3 Number of adverse events following postexposure prophylaxis

Type of AEs	Number of AEs (%)	
Local AEs		
 Pain	39 (9.63)	
 Erythema	1 (0.25)	
 Swelling	1 (0.25)	
 Tenderness	11 (2.72)	
 Induration	1 (0.25)	
Systemic AEs		
 Fever	1 (0.25)	
 Headache	0	
 Malaise	5 (1.23)	
 Arthralgia	0	
 Myalgia	4 (0.99)	
 Nausea	0	
 Vomiting	0	
Total	63 (12.35)	
AEs: Adverse events

Table 4 Age-group-wise distribution of adverse events

Age groups (years)	Local solicited AEs	
	
Pain, n (%)	Erythema, n (%)	Swelling, n (%)	Tenderness, n (%)	Induration, n (%)	
Child (<5)	2 (28.57)	0	0	2 (28.57)	0	
Child (≥5 and≤12)	7 (16.67)	0	0	1 (2.38)	0	
Adolescent (≥13 and ≤17)	3 (11.54)	0	0	0	0	
Adult (≥18 and≤65)	24 (7.79)	1 (0.32)	1 (0.32)	7 (2.27)	1 (0.32)	
Geriatric (>65)	3 (13.64)	0	0	1 (4.55)	0	
AEs: Adverse events

Overall tolerability

The majority of the study participants (88.9%) reported excellent tolerability of TwinRab™ whereas 11.1% of study participants reported good tolerability of TwinRab™. As per investigator discretion, TwinRab™ showed 89.1% excellent tolerability and 10.9% good tolerability in study participants.

Discussion

Passive vaccination, a cornerstone of WHO’s PEP protocols for rabies prevention, involves serum application and a 14-day vaccine course. Despite these established measures, rabies remains a significant threat due to factors such as noncompliance, delayed treatment, and vaccine shortages.[10] TwinRab™, an innovative alternative to traditional RIGs, has demonstrated safety and efficacy in clinical trials. Phase 1/2 and phase-3 trials have validated TwinRab™’s safety and noninferiority to HRIG in category III rabies exposures, providing protection for up to 84 days. Observational studies have highlighted mild local AEs post-PEP, while postmarketing evaluations have indicated TwinRab™’s well-tolerated nature across various age groups, with no reported PEP failures, underscoring its real-world effectiveness.[811]

In comparison to TwinRab™, rabishield also offers passive immunization for rabies prophylaxis. However, TwinRab™ presents several potential advantages over rabishield. TwinRab™ targets different sites on the rabies G protein, providing a comprehensive approach to neutralizing the virus, while rabishield, a single mAb, binds to a single epitope, potentially offering a narrower range of neutralization. TwinRab™ has demonstrated higher potency, lack of interference with antiretroviral medications, and lower volume requirements for administration, presenting clear advantages over rabishield. Rabishield, a mAb product developed in India, targets a conformational epitope of the rabies virus glycoprotein, with a broad spectrum of neutralization. However, concerns arise due to its mono-specificity, raising issues about the potential lack of neutralization of emerging rabies variants, and the risk of the selection of viral escape mutants.[12]

The present study conducted at a government hospital in Northern India with 405 patients aimed to evaluate the postmarketing safety of TwinRab™ in combination with a full course of anti-rabies vaccination for PEP regimen in patients with suspected category animal exposures. The study revealed that the TwinRab™ containing PEP regimen was safe and well-tolerated across all participants, with an overwhelming majority (88.9%) reporting excellent tolerability. Notably, no withdrawals due to PEP failure were reported, further supporting TwinRab’s™ overall good tolerability. The study reported an overall incidence of 12.35% for AEs, primarily mild and transient, with 9.88% local and 2.47% systemic events. Common local AEs included pain, tenderness, erythema, swelling, and induration, while systemic AEs comprised myalgia, malaise, and fever, predominantly observed in adults. Despite these AEs, the majority of participants rated the tolerability of TwinRab™ as excellent. TwinRab™ was administered at doses ranging from 320 IU to 4400 IU, with positive outcomes observed across different age groups.

Similarly, postmarketing surveillance studies conducted at ID and BG, Kolkata, and BJMC, Pune, further supported TwinRab™’s safety and tolerability. The ID and BG study, involving 401 participants, reported mild local AEs in 9.98% of individuals, all of which resolved without complications. TwinRab™ was administered safely across a wide age range, from 1 year old to 90 years old, without any AEs reported with a maximum dose of 3800 IU. Similarly, the BJMC study, with 215 patients, noted only three solicited local AEs in the adult age group, effectively managed and resolved, with no SAEs reported across all age groups. Pediatric patients exhibited no AEs, highlighting the safety profile of TwinRab™. These collective findings confirm TwinRab™’s safety and reliability for rabies PEP across diverse populations.[1314]

Conclusion

TwinRab™ has demonstrated safety in the present study, making it a promising alternative to traditional RIGs. It shows good tolerability across diverse populations, supporting its reliability for rabies PEP. Notably, no AEs were reported in pediatric, adolescent, or geriatric populations, confirming their safety across all age groups. The combination of mAbs, docaravimab, and miromavimab, has been found safe during postmarketing surveillance. These findings suggest that TwinRab™ could enhance the accessibility and affordability of rabies prevention in India and other endemic countries, although further research is needed to confirm its effectiveness and safety in various settings.

Ethical approval statement

The study was registered in the CTRI on November 2, 2022, with registration number CTRI/2022/11/046994 and obtained approval from the institutional ethics committee (Ref. No.: Trg. 9 (310) 2022/dated November 25, 2022).

Financial support and sponsorship

This study was supported by Zydus Life Sciences Limited.

Conflicts of interest

There are no conflicts of interest.

Acknowledgments

We express our sincere appreciation and gratitude to Dr. Prachi Sharmaand Koshy Jacob, Medical Affairs at Digicare Health Solutions Private Limited, who contributed significantly to the conduct of the postmarketing surveillance study.
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