Riacon 2011- DR.PATNAIK

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LONG TERM IMMUNOGENICITY OF ABHAYRAB

LONG TERM IMMUNOGENICITY OF ABHAYRAB

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  • 1. RABIES FREE WORLD……… the one who needs the most
  • 2. Persistence of neutralizing antibody inpreviously vaccinated subjects: Multiple studies showing long lasting immunity with ABHAYRAB “Impact on rabies immunization practice…” DR. B N PATNAIK, MD Head clinical Development INDIA
  • 3. In the absence of PEP vaccination it is assumed that justunder 20% of victims of bites by rabid animals develop rabiesand that all clinical cases of human rabies result in death(1).Incomplete PEP vaccination is less effective and almost 10% of human rabies cases reported from India had received incomplete PEP vaccination with CCVs (2) 1. Shim E, Hampson K, Cleaveland S, Galvani AP (2009) Evaluating the cost-effectiveness of rabies post-exposure prophylaxis: a case study in Tanzania. Vaccine 27: 7167–7172 2. Sudarshan MK, Madhusudana SN, Mahendra BJ, Rao NSN, Ashwath Narayana DH, et al. (2007) Assessing the burden of human rabies in India: results of a national multi-center epidemiological survey. International Journal of Infectious Diseases 11: 29–35.
  • 4. Initial Abhayrab studies… Class of No. of Abhayrab ERIG Ab titres Bite Subjects schedule on Group I Healthy 60 Days 0, 7 Not given Days 0,14,35 volunteers and 21 and 365 Group II Category II 75 Days 0, 3, 7, Not given Days 0, 14, 14,30 and 90 30, 90 and 365 Group III Category III 67 Days 0, 3, 7, Not given Days 0, 14, 14,30 and 90 30, 90 and 365 Group IV Category III 88 Days 0, 3, 7, Given Days 0, 14, 14,30 and 90 30, 90 and 365Published by Elsevier Ltd in 2004Conducted by :Institute of Preventive Medicine, Narayanguda, Hyderabad,Pasteur Institute of India, Connor, Tamilnadu, India
  • 5. Persistence of Ab over time 20 19 18 18.19 17 GROUP I 16 15.78 15 15.03 GROUP II 14 13 13.53 GROUP III 12.69 12.26 12 11.66 GROUP IVGMT 11 10 10.34 9 9.47 8 8.04 8.42 7.82 7 7.04 6 5.8 5 4 4.15 3 2 1 0.61 0.83 0.78 0 0 0 7 14Days 35 90 365
  • 6. Multi-centric study on the use of intradermal administration of tissue culture antirabies vaccines in IndiaMethods:Healthy volunteers selected from five centres in the country.The TCARVs used for intradermal administration were Purified Vero cell Rabies vaccine (PVRV Abhayrab and Coonoor), Purified chicken embryo cell vaccine (PCEC Rabipur) and Purified duck embryo vaccine ( PDEV Vaxirab) with a 2-2-2-0-1-1 regimen.Responses to intradermal TCARVs were compared with that of French PVRV (Aventis)administered intramuscularly on 0, 3, 7,14 and 28 days. Ten volunteers were recruited for each of the TCARV arm in each center as well as forcontrol group receiving French PVRV.Blood samples were collected on days 14, 28, 90 and 180 daysStudy done by : Indian Council of Medical Research
  • 7. Sero-protection rate, GMTs, of Anti-Rabies antibodies and its 95% CI among the volunteers receiving different TCRVs
  • 8. Sero-protection rate, Geometric mean titers of anti-rabies antibodies an ICMR Study
  • 9. IMMUNOGENECITY OF PURIFIED VERO CELL RABIES VACCINE USED IN THE TREATMENT OF FOX-BITE VICTIMS IN INDIA • 19 Patients aged 6-70 years • Category III fox bites • Abhayrab was administered IM to all on days 0,3,7,14 and 28 • 6 patients were treated with equine rabies antiserum (Central research institute) • 11 patients were administered abhayrab booster on day 1020 after the first dose • Blood was collected for antibody titre estimation on days 30,90,870,1020, and 1050Study by Dr. I S Matha of district hospital Nasik and Dr.S R Salunke of Directorateof health services ,Mumbai,India
  • 10. Response to a booster vaccination on day 1020 afterthe first dose of vaccine in patients who had received either vaccine alone or vaccine + ERIGDays after 1st No. of GMT Value, IU dose of Patients Mean Range vaccine 30 12 3.16 1.00 – 8.00 90 16 25.00 8.00 – 64.00 870 11 0.77 0.26 – 2.10 1020 11 0.48 0.11 – 2.00 1050 11 30.08 2.57 – 69.18
  • 11. REVIEW OF EXISTING ANTIBODIES IN TREATED POST-EXPOSURE BY CELL CULTURE VACCINES: ABHAYRAB ( IM )REGIMEN ONE YEAR FROM THE FIRST INJECTIONS (VIETNAM) PRINCIPAL INVESTIGATOR: PROF ĐINH KIM XUYẾN, PhD DEPUTY DIRECTOR OF CENTER FOR SCIENTIFIC RESEARCH FOR CUMMUNITY HEALTH,HANOI,VIETNAM
  • 12. Rabies Virus Neutralizing Antibody (RVNA) Concentration by age group Characteristics n = 101 people ≤ 15 years old > 15 years old No. of subjects 26 75 RVNA GMT 95 % CI GMT 95 % CI48 to >53 Week 2.06 ± 1.14 1.97 ± 1.19 Antibody concentration in the age ≤ 15 years old higher than the age >15 not but not statistically significant( P>0.05)
  • 13. Antibody concentrations over time from first dose to evaluation weeks ANTIBODY CONCENTRATION TIME(IN WKS AFTER FIRST TOTAL DOSE) 0.5-1 1.1-5 >5 48-50 22 5 9 5 51-53 29 10 12 6 >53 69 25 21 8 Total 120 40 42 19
  • 14. Study to compare the safety and immunogenicityof Abhayrab with commercially available Rabipurvaccine, both administered as per updated Thai Regimen (2-2-2-0-2) in healthy volunteers (simulated post-exposure study)
  • 15. Antibody titers GMT (IU/mL) (%) of Subjects Seroconverted Abhayrab Rabipur Abhayrab Rabipur Vaccine Vaccine Vaccine VaccinePre vaccination 0.12 (42) 0.10 (50) -- --Day 0 (N) (0.00, 0.48) (0.00,0.40)Range (Min, Max)Post VaccinationDay 38 (N) 60.39 (42) 56.55 (50) 100 100Range (Min, Max) (10.81, 247.66) (70.14, 247.66)Day 365 (N) 0.94 (25) 1.15 (25) 100 100Range (Min, Max) (0.54, 3.09) (0.56, 4.03)
  • 16. SEROPROTECTION
  • 17. Implications…….• Reduced PrEP regimens would reduce the cost of protecting vulnerable populations against rabies and would promote better compliance.• thus supporting opportunities to conduct mass PrEP rabies vaccination in children, the population most at risk of dying of this dreaded disease.
  • 18. Implication……• (PVRV) administered as a pre- or post-exposure series will provide very long lasting immune memory in normal host recipients.• Two intradermal booster injections on days 0 and 3 will result in an accelerated anamnestic neutralizing antibody response and obliviate the need for rabies immunoglobulin in the event of a new exposure K. Suwansrinon et al. / Vaccine 24 (2006) 3878–3880
  • 19. Possible Future !! Inclusion of Intradermal PVRV in EPI (Along with DTP vaccine schedule) of developing/Rabies Endemic countries.. Large CTs to validate the number and age for boosters We can possibly keep Rabies related Death to a minimum…..
  • 20. THANKS