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Introduction <p>Rabies, a universally fatal viral infection of the central nervous system, remains a significant public health challenge in endemic regions like India. Although pre-exposure prophylaxis (PrEP) is a critical preventive measure, logistical and financial barriers restrict its widespread implementation. The World Health Organization (WHO) has recommended single-visit PrEP schedules to overcome these challenges, necessitating their evaluation in endemic settings.</p> Methods <p>A randomized, double-blind, non-inferiority clinical trial was conducted with 41 healthy, immunologically naïve participants divided into two groups. Group A received a multi-visit PrEP schedule (0.1 mL intradermally at two sites on days 0, 7). Group B underwent single-visit PrEP (0.1 mL at four sites on day 0). Antibody titers were measured using ELISA on days 0 and 28. Data were analyzed for seroconversion rates, immunogenicity, and influencing factors using statistical methods.</p> Results <p>In Group A, 4 out of 5 (80%) participants showed sufficient seroconversion while 1 (20%) showed insufficient seroconversion, and in Group B, 26 out of 30 (86.67%) showed sufficient seroconversion and 4 (13.3%) showed insufficient seroconversion. Both groups showed significant increases in antibody seroconversion (OD)titres from baseline (<i>p</i> = 0.0038 for Group A, <i>p</i> &lt; 0.0001 for Group B). Regression analysis indicated no significant influence of demographic factors on antibody levels. The single-visit schedule achieved comparable efficacy with fewer logistical barriers.</p> Conclusions <p>Single-visit PrEP schedules represent an effective and feasible alternative to conventional protocols, aligning with WHO recommendations. They offer a scalable solution to enhance rabies prevention in resource-constrained settings, although further research is needed to assess long-term immunity and broader applicability.</p> Clinical trial number <p>This study was registered and approved prospectively with CLINICAL TRIAL REGISTRY OF INDIA with the following registration number - CTRI APPROVAL NO – CTRI/2024/10/075093 registered on 10/10/2024.</p>

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One-step ahead: evaluating the efficacy of single-visit rabies pre-exposure prophylaxis against conventional multi-visit protocol: a randomized non-inferiority clinical trial

  • 期刊论文

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  • 发表日期：

    2025年8月7日

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  • Aman Dev Singh,
  • Simmi Oberoi,
  • Rohit Batish,
  • Kanwardeep Singh,
  • Maninder Kaur,
  • Shailpreet Kaur Sidhu,
  • Avneet Kaur,
  • Prabhasees Singh

摘要

Introduction

Rabies, a universally fatal viral infection of the central nervous system, remains a significant public health challenge in endemic regions like India. Although pre-exposure prophylaxis (PrEP) is a critical preventive measure, logistical and financial barriers restrict its widespread implementation. The World Health Organization (WHO) has recommended single-visit PrEP schedules to overcome these challenges, necessitating their evaluation in endemic settings.

Methods

A randomized, double-blind, non-inferiority clinical trial was conducted with 41 healthy, immunologically naïve participants divided into two groups. Group A received a multi-visit PrEP schedule (0.1 mL intradermally at two sites on days 0, 7). Group B underwent single-visit PrEP (0.1 mL at four sites on day 0). Antibody titers were measured using ELISA on days 0 and 28. Data were analyzed for seroconversion rates, immunogenicity, and influencing factors using statistical methods.

Results

In Group A, 4 out of 5 (80%) participants showed sufficient seroconversion while 1 (20%) showed insufficient seroconversion, and in Group B, 26 out of 30 (86.67%) showed sufficient seroconversion and 4 (13.3%) showed insufficient seroconversion. Both groups showed significant increases in antibody seroconversion (OD)titres from baseline (p = 0.0038 for Group A, p < 0.0001 for Group B). Regression analysis indicated no significant influence of demographic factors on antibody levels. The single-visit schedule achieved comparable efficacy with fewer logistical barriers.

Conclusions

Single-visit PrEP schedules represent an effective and feasible alternative to conventional protocols, aligning with WHO recommendations. They offer a scalable solution to enhance rabies prevention in resource-constrained settings, although further research is needed to assess long-term immunity and broader applicability.

Clinical trial number

This study was registered and approved prospectively with CLINICAL TRIAL REGISTRY OF INDIA with the following registration number - CTRI APPROVAL NO – CTRI/2024/10/075093 registered on 10/10/2024.