Evaluation of a one week intradermal regimen for rabies post-exposure prophylaxis: Results of a randomized, open label, active-controlled trial in healthy adult volunteers in India

Sudarshan, Mysore Kalappa; Narayana, Doddabele Hanumanthaiah Ashwath; Madhusudana, Shampur Narayan; Holla, Ramesh; Ashwin, Belludi Yajaman; Bilagumba, Gangaboraiah; Ravish, H

doi:10.4161/hv.20471

Cited by 38 publications

(31 citation statements)

References 10 publications

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Section: Discussionsupporting

confidence: 77%

“…7,16,17,20 The immune response elicited in this study on day 14 was comparable with studies done using updated TRC regimen, Essen regimen and one week, 4 site intradermal regimen. 7,16,17,20 Similarly, the immune response in the present study on day 90 was comparable with Essen regimen. 20 All the study subjects in both the groups of vaccines on day 365 had adequate RVNA concentration of 0.5 IU/mL, whereas the previous study from India showed that the RVNA concentration was <0.5 IU/mL among 21.1% subjects in Rabipur group and 37.5% subjects in Verorab group.…”

Section: Discussionsupporting

confidence: 77%

“…1,6 Studies done in Thailand and India among healthy volunteers using one week, 4 site intradermal regimen, the rabies vaccines were proved to be safe and immunogenic. 5,7 The improved compliance and cost effectiveness of this regimen along with advantages and disadvantages of other PEP regimens is very well discussed by Hampson et.al. 19 This was a pioneering study on animal bite cases, where only adults between 18 to 55 years of age were enrolled as study subjects.…”

Section: Discussionmentioning

confidence: 99%

“…The study concluded that PCECV and PVRV when administered intradermally using one week, 4 site ID regimen was safe and immunogenic for rabies PEP. 7 The recent WHO expert consultation on rabies held at Geneva in September, 2012 recommended more research on 4 site intradermal regimen with 0.1 mL per site (4-4-4-0-0) in association with rabies immunoglobulin, so as to reduce the expense of traveling to clinics which will improve patient compliance. 1 In this background, this study was undertaken with the following objectives:…”

Section: Introductionmentioning

confidence: 99%

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Comparison of safety and immunogenicity of 2 WHO prequalified rabies vaccines administered by one week, 4 site intra dermal regimen (4-4-4-0-0) in animal bite cases

Narayana

Manoharan

Narayan

et al. 2015

Human Vaccines & Immunotherapeutics

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The currently advocated rabies post-exposure prophylaxis regimens are of one month duration with reduced patient compliance. WHO recommended research on shortened vaccination regimens which have a practical and economic advantage over the existing regimens. Hence, the present study was undertaken to assess the safety and immunogenicity of 2 WHO prequalified rabies vaccines administered by one week, 4 site intra dermal regimen (4-4-4-0-0) in animal bite cases. This study was a comparative, open label, phase III, randomized clinical trial conducted at Anti rabies clinic, KIMS Hospital, Bangalore, India. The study was registered in Clinical Trials Registry of India (CTRI) bearing the registration number CTRI/2012/12/003230. Ninety subjects with category II/III animal bites/exposures were enrolled. Equine rabies immunoglobulin was administered to all category III exposures. 0.1 mL of either purified chick embryo cell vaccine (Rabipur) or purified verocell rabies vaccine (Verorab) was administered intradermally into 4 sites on days 0, 3 and 7 to all the study subjects. Serum of subjects collected on day 0, 14, 90 and 365 were analyzed for rabies virus neutralizing antibody (RVNA) concentration. The incidence of ADR in Rabipur and Verorab group was 2.96% and 1.14% respectively. In Rabipur group, geometric mean concentration (95% confidence interval) of RVNA was 14.5 (13.50, 15.57), 11.78 (11.27, 12.31) and 5.95 (5.50, 6.44) IU/mL on days 14, 90 and 365 respectively; In Verorab group geometric mean concentration (95% confidence interval) of RVNA was 14. 43 (13.41, 15.53), 11.93 (11.47, 12.40) and 5.67 (5.29, 6.08) IU/mL on days 14, 90 and 365 respectively. In conclusion, Rabipur and Verorab were found to be safe, immunogenic and comparable with each other, when administered using one week, 4 site intradermal regimen (4-4-4-0-0) in animal bite cases.

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Section: Discussionsupporting

confidence: 77%

Section: Discussionsupporting

confidence: 77%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Comparison of safety and immunogenicity of 2 WHO prequalified rabies vaccines administered by one week, 4 site intra dermal regimen (4-4-4-0-0) in animal bite cases

Narayana

Manoharan

Narayan

et al. 2015

Human Vaccines & Immunotherapeutics

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“…Although mild systemic reactions, such as headache, nausea, abdominal pain, myalgia, had been reported in up to 31% of PCECV vaccine recipients 6 and about 1% of PVRV vaccines, 7,8 severe allergic reaction, like this reported case, was rare. It was very difficult to define the allergic reaction associated to the rabies vaccine, in particular for the reaction to only one component that was not noted.…”

Section: Discussionmentioning

confidence: 50%

Rabies post-exposure prophylaxis for a child with severe allergic reaction to rabies vaccine

Fang

Liu

Chen

et al. 2016

Human Vaccines & Immunotherapeutics

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Most adverse events (AEs) during the immunization of rabies vaccine were slight, there was little information about the allergic reaction induced by rabies vaccines and had to stop or change the immunization program. Here, we reported a case that a 4-year-old boy had category II exposure to rabies and showed severe allergic reaction after being immunized with lyophilized purified vero cell rabies vaccine (PVRV). After the anti-allergy therapy with hormone, allergy testing indicated medium allergy to egg and milk, and implied the allergic reaction most likely associated with animal-sourced gelatin in lyophilized PVRV. Therefore, a new immunization program with liquid PVRV without stabilizers under the Zegrab regimen (2-1-1) was enrolled at day 7 post-exposure. Although lower than the levels of normal <5 -year population at day 14 and 45, the neutralizing antibody (RVNA) titers of this boy showed adequate protective antibody ( 0.5 IU/ml), even after 365 d post-immunization. This study not only highlighted the importance of several types of rabies vaccines co-existing in the market, but also implied the necessary for doctors to fully understand the allergies history of patients prior to immunize rabies vaccine.

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OBSOLETE: Rabies

Wilde¹

2017

Reference Module in Biomedical Sciences

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Evaluation of a one week intradermal regimen for rabies post-exposure prophylaxis: Results of a randomized, open label, active-controlled trial in healthy adult volunteers in India

Cited by 38 publications

References 10 publications

Comparison of safety and immunogenicity of 2 WHO prequalified rabies vaccines administered by one week, 4 site intra dermal regimen (4-4-4-0-0) in animal bite cases

Comparison of safety and immunogenicity of 2 WHO prequalified rabies vaccines administered by one week, 4 site intra dermal regimen (4-4-4-0-0) in animal bite cases

Rabies post-exposure prophylaxis for a child with severe allergic reaction to rabies vaccine

OBSOLETE: Rabies

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