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Dr.MK Sudarshan
 

Dr.MK Sudarshan

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AREB MEETING, AT PATTAYA,THAILAND FROM DEC. 6-7, 2011

AREB MEETING, AT PATTAYA,THAILAND FROM DEC. 6-7, 2011

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  • Full Name Full Name Comment goes here.
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  • Creativebeans if you need only two doses of ARV first 0 then 3rd day only if it is category three bite.
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  • sir , I received 5 doses of verorab from 18 feb -17 march 2012 .. day 0,3,7,14 & 28 ... then I had a cat scratch on june 15 .. should I have got booster shots for the same? for how long do these 5 shots give immunity ? my doc gave me only 1 booster dose to be safe but I read on internet that u need 2 doses .. the scratch was within 3 months of PEP .
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    Dr.MK Sudarshan Dr.MK Sudarshan Presentation Transcript

    • What should be the time interval for a booster vaccination following re-exposure to rabies in previously vaccinated individuals ? Dr. M. K. Sudarshan , MBBS, MD [BHU], FAMS, Hon. FFPH [UK] Dean/Principal and Professor of Community Medicine President, Rabies in Asia Foundation Kempegowda Institute of Medical Sciences Bangalore, India Email: mksudarshan@gmail.com
    • Introduction
      • In rabies endemic areas, the incidence of re-exposures is up to 15%.
      • According to WHO (2010), for rabies-exposed patients who have completed PrEP or PEP with a CCV, 1 dose delivered IM or ID on days 0 and 3 is sufficient. RIG is not indicated here.
    • Introduction
      • However, the recommendations of WHO do not specify the duration of protection offered by a previous PrEP or PEP; but states that –
        • Long-lasting immunity against rabies depends on immunological memory, which can be demonstrated by a rapid (anamnestic) antibody response to a booster dose
        • Anamnestic responses following booster doses have been observed even 21 years after primary vaccination
        • Long-lasting immunity against rabies is achieved regardless of route of immunization (IM or ID) and follows pre-exposure as well as post-exposure immunization
        • Due to the long duration of protection, regular booster doses of the vaccine are not recommended following a completed pre-exposure or post-exposure series except for certain groups at continual, frequent or increased risk.
    • Introduction
      • Besides in the available literature there are no clear documented references to the duration of protection offered by a primary series of PrEP or PEP immunization.
      • This leads to dilemma in anti-rabies clinics/physicians that/who often see cases of re-exposures in rabies endemic areas, more so where free roaming dogs are a menace.
      • Hence, this study aims to define the duration of protection offered by a primary series of PreP or PEP immunization by examining the anti- rabies antibody kinetics in previously vaccinated persons.
    • Materials and Method
      • Using PUBMED and Google Scholar, 19 articles published in national and international journals were reviewed
      • Besides, in house data of 4 clinical trials was reviewed
      • Period covered/duration - 1983 to 2010 ( 27 years )
      • 66 vaccine cohorts from six countries i.e. France, Germany, India, Thailand, UK and USA
      • 55 cohorts of PEP and 11 cohorts of PrEP
      • 29 cohorts of RIGs : 21 cohorts of ERIG and 8 cohorts of HRIG
      • 3372 Vaccinees ( 577 persons of PrEP and 2795 patients of PEP )
      • Vaccines used – HDCV, PCECV, PVRV and PDEV
      • Regimens: IM - Essen ( 5 dose ) and ID- TRC, updated TRC and Oxford
    • CRITERION
      • The RVNA concentration of ≥ 0.5 IU per mL in a vaccinated healthy individual, which as per WHO is considered as adequate for protection against rabies, was used as a surrogate marker.
      • Hence, the focus was on number of patients/subjects who produced an inadequate RVNA concentration (<0.5 IU per mL) to a full course of vaccination given either IM or ID with or without RIGs during the first six months; and wherever available up to one year post-vaccination.
    • Results Table 1. Antibody response to PEP immunization Note: 0.07% and 0.14% of rabies exposed persons had inadequate (<0.5IU/mL) RVNA response at the end of first and third month post-primary PEP, with or without RIG. Route of administration of Vaccine Enrolment/ Recruitment RIGs used Vaccinees with inadequate antibody response Cohorts Subjects /Patients Cohorts Subjects / Patients Day 28 Day 90 Day 180 Day 365 Total Intramuscular Intradermal 23 1314 12 636 0/1238 0/1051 3 /670 9/99 12 32 1481 17 690 2 /1268 4 /1366 3 /719 37/558 46 Total 55 2795 29 1326 2 /2506 4 /2417 6 /1389 46/657 58
    • Table 2. Antibody response to PrEP vaccination Note: All had adequate (≥0.5 IU per mL) RVNA response up to three months post primary PrEP vaccination. Route of administration of Vaccine Enrolment/ Recruitment Vaccinees with inadequate antibody response Cohorts Subjects /Patients Day 28 Day 90 Day 180 Day 365 Total Intramuscular 8 518 0/263 0/33 4 / 37 12/ 209 16 Intradermal 3 59 0/59 0/59 0/33 0/59 - Total 11 577 0/322 0/92 4 /70 12/268 16
    • Discussion
      • Adequate RVNA response is usually seen by day 14 or at least by day 28 in all PEP cases and by day 35 in all PrEP subjects, who are otherwise generally healthy / immune competent.
      • Subsequently, the RVNA concentration gradually declines and wanes away, leaving behind an immunological memory.
      • However, such individuals as an anamnestic response rapidly respond to booster vaccination.
      • In this study, however, 0.07% and 0.14% of rabies exposed persons had inadequate (<0.5IU/mL) RVNA response at the end of first and third month post-primary PEP with or without RIG. However, all PrEP vaccinated persons had adequate RVNA up to 3 months post primary vaccination.
      • It was considered that this small proportion of poor/non-response could be due to poor vaccine/administration/health status of the persons.
    • Conclusion
      • In the absence of clear mandate by WHO-
      • Thailand and Philippines have issued local guidelines that mandate boosters six months after the previous PEP or PrEP in persons who were re-exposed to rabies.
      • In Sri Lanka, it is twelve months.
      • However, the data generated from this study mandates –
        • Booster vaccination three months after a post primary PEP or PrEP vaccination using a CCV or PDEV.
        • This is for the comments of this AREB group and for a position statement by the next WHO expert consultation due in 2012?
    • Reference
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      • Strady A, Lang J, Lienard M, Blondeau C, Jaussaud R, Plotkin SA. Antibody persistence following preexposure regimens of cell culture rabies vaccines: 10- year follow-up and proposal for a new booster policy. JID 1998; 177: 1290-95.
      • Ajjan N, Pilet Ch. Comparative study of the safety and protective value in pre-exposure use of rabies vaccine cultivated on human diploid cells (HDCV) and of the new vaccine grown on vero cells. Vaccine 1989; 7: 125-28.
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      • Madhusudana SN, Premanand N. Response to purified chick embryo cell rabies vaccine administered intradermally for post-exposure prophylaxis. The National Medical Journal of India 1997; 10(3): 115-16.
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      • Sudarshan MK, Madhusudhana SN, Mahendra BJ. Post exposure prophylaxis with purified verocell rabies vaccine during pregnancy–safety and immunogenicity. J.Commun. Dis. 1999; 31(4):229-36.
      • A report on “A comparative, multi center Phase III, randomized (1:1) double blind study to evaluate the safety and immunogenicity of PVRV (Indirab vs. reference vaccine) administered intradermally using simulated updated Thai Red cross regimen in healthy volunteers. 2009, Bharath Biotech International Ltd, Hyderabad, India.
      • A report on “A comparative phase III, randomized (1:1) single blind study to evaluate the safety and immunogenicity of rabies vaccines (Indirab vs reference vaccine) reconstituted with 1 mL diluent each, administered intradermally using simulated post exposure updated Thai Red Cross regimen in healthy volunteers”. 2009, Bharath Biotech International Ltd, Hyderabad, India.
      • Mahendra BJ, Madhusudhana SN, Ashwath Narayana DH, Sampath G, Datta SS, Gangaboraiah et al. A comparative study on the immunogenicity, safety and tolerance of purified duck embryo vaccine manufactured in India and Switzerland: A randomized simulated post-exposure study in healthy volunteers. Vaccine 2007; 25: 8405-09.
      • Sudarshan MK, Mahendra BJ, Madhusudhana SN, Ashwath Narayana DH. Administration of purified verocell rabies vaccine during pregnancy: Results of a controlled clinical trial. J. of Obst. & Gyn. of India 2002; 52(2): 48-52.
      • Madhusudana SN, Sanjay TV, Mahendra BJ, Sudarshan MK, Ashwath Narayana DH, Anandgiri et al. Comparison of safety and immunogenicity of purified chick embryo cell rabies vaccine (PCEC) and purified vero cell rabies vaccine (PVRV) using the thai red cross intradermal regimen at a dose of 0.1ml. Human Vaccines 2006; 2(5): 200-04.
      • Sudarshan MK, Mahendra BJ, Madhusudhana SN, Ashwath Narayana DH, Jayakumary M, Gangaboraiah. Post exposure rabies prophylaxis with purified verocell rabies vaccine: A study of immune response in pregnant women and their matched controls. Indian Journal of Public Health 1999; 43(2): 76-78.
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    • Asian Biomedicine Vol 5, No 5, October 2011: 589-593
    • Thank you for your kind attention Taj Mahal, India