One-step ahead: evaluating the efficacy of single-visit rabies pre-exposure prophylaxis against conventional multi-visit protocol: a randomized non-inferiority clinical trial
Abstract 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 wide...
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BMC
2025-08-01
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| Series: | Tropical Diseases, Travel Medicine and Vaccines |
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| Online Access: | https://doi.org/10.1186/s40794-025-00262-3 |
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| author | Aman Dev Singh Simmi Oberoi Rohit Batish Kanwardeep Singh Maninder Kaur Shailpreet Kaur Sidhu Avneet Kaur Prabhasees Singh |
| author_facet | Aman Dev Singh Simmi Oberoi Rohit Batish Kanwardeep Singh Maninder Kaur Shailpreet Kaur Sidhu Avneet Kaur Prabhasees Singh |
| author_sort | Aman Dev Singh |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-231c98ac4653485fa8ea2c2bb6cb0482 |
| institution | Kabale University |
| issn | 2055-0936 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Tropical Diseases, Travel Medicine and Vaccines |
| spelling | doaj-art-231c98ac4653485fa8ea2c2bb6cb04822025-08-24T11:08:56ZengBMCTropical Diseases, Travel Medicine and Vaccines2055-09362025-08-0111111010.1186/s40794-025-00262-3One-step ahead: evaluating the efficacy of single-visit rabies pre-exposure prophylaxis against conventional multi-visit protocol: a randomized non-inferiority clinical trialAman Dev Singh0Simmi Oberoi1Rohit Batish2Kanwardeep Singh3Maninder Kaur4Shailpreet Kaur Sidhu5Avneet Kaur6Prabhasees Singh7Government Medical College and Rajindra HospitalGovernment Medical College and Rajindra HospitalGovernment Medical College and Rajindra HospitalGovernment Medical College and Guru Nanak Dev HospitalGovernment Medical College and Guru Nanak Dev HospitalGovernment Medical College and Guru Nanak Dev HospitalState University of New York (SUNY UPSTATE) New YorkGovernment Medical College and Rajindra HospitalAbstract 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.https://doi.org/10.1186/s40794-025-00262-3RabiesRabies vaccinesHumoral immunity pre-exposure prophylaxisDrug administration scheduleDisease prevention |
| spellingShingle | Aman Dev Singh Simmi Oberoi Rohit Batish Kanwardeep Singh Maninder Kaur Shailpreet Kaur Sidhu Avneet Kaur Prabhasees Singh One-step ahead: evaluating the efficacy of single-visit rabies pre-exposure prophylaxis against conventional multi-visit protocol: a randomized non-inferiority clinical trial Tropical Diseases, Travel Medicine and Vaccines Rabies Rabies vaccines Humoral immunity pre-exposure prophylaxis Drug administration schedule Disease prevention |
| title | One-step ahead: evaluating the efficacy of single-visit rabies pre-exposure prophylaxis against conventional multi-visit protocol: a randomized non-inferiority clinical trial |
| title_full | One-step ahead: evaluating the efficacy of single-visit rabies pre-exposure prophylaxis against conventional multi-visit protocol: a randomized non-inferiority clinical trial |
| title_fullStr | One-step ahead: evaluating the efficacy of single-visit rabies pre-exposure prophylaxis against conventional multi-visit protocol: a randomized non-inferiority clinical trial |
| title_full_unstemmed | One-step ahead: evaluating the efficacy of single-visit rabies pre-exposure prophylaxis against conventional multi-visit protocol: a randomized non-inferiority clinical trial |
| title_short | One-step ahead: evaluating the efficacy of single-visit rabies pre-exposure prophylaxis against conventional multi-visit protocol: a randomized non-inferiority clinical trial |
| title_sort | one step ahead evaluating the efficacy of single visit rabies pre exposure prophylaxis against conventional multi visit protocol a randomized non inferiority clinical trial |
| topic | Rabies Rabies vaccines Humoral immunity pre-exposure prophylaxis Drug administration schedule Disease prevention |
| url | https://doi.org/10.1186/s40794-025-00262-3 |
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