Evidence map›Paper›PMID 39310081›Full record

ArticleInternational journal of applied & basic medical research

Assessing the Safety of a Novel Monoclonal Antibody Cocktail for Postexposure Prophylaxis in Category III Animal Exposures.

Amandev Singh, Raminderpal Singh Sibia, Simmi Oberoi, Lovleen Bhatia, Sachin Kaushal, Trayambak Dutta, Manish Mahajan, Samir Desai

Abstract read
In one paragraph

Article in International journal of applied & basic medical research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Amandev SinghDepartment of Community Medicine, Government Medical College, Patiala, Punjab, India.
Raminderpal Singh SibiaDepartment of Medicine, Government Medical College, Patiala, Punjab, India.
Simmi OberoiDepartment of Community Medicine, Government Medical College, Patiala, Punjab, India.
Lovleen BhatiaDepartment of Medicine, Government Medical College, Patiala, Punjab, India.
Sachin KaushalDepartment of Medicine, Government Medical College, Patiala, Punjab, India.
Trayambak DuttaZydus Lifesciences Limited, Ahmedabad, Gujarat, India.
Manish MahajanZydus Lifesciences Limited, Ahmedabad, Gujarat, India.
Samir DesaiZydus Lifesciences Limited, Ahmedabad, Gujarat, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Category III animal exposurespostexposure prophylaxisrabiessafetyTwinRab™

Identifiers

PMID39310081
PMCPMC11412560

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.