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BHK-21 RABIES VACCINE – A CANDIDATE VACCINE FOR HUMANS Dusan Lalosevic, MD, Ph.D.* Pasteur Institute in Novi Sad, Serbia *Present address: Faculty of Medicine.

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Presentation on theme: "BHK-21 RABIES VACCINE – A CANDIDATE VACCINE FOR HUMANS Dusan Lalosevic, MD, Ph.D.* Pasteur Institute in Novi Sad, Serbia *Present address: Faculty of Medicine."— Presentation transcript:

1 BHK-21 RABIES VACCINE – A CANDIDATE VACCINE FOR HUMANS Dusan Lalosevic, MD, Ph.D.* Pasteur Institute in Novi Sad, Serbia *Present address: Faculty of Medicine and Clinical Center in Novi Sad, Serbia

2 Country Report In the North community Subotica, a trial of oral vaccination started by delta- planes sponsored by VIRBAC

3 BHK-21 C 13 cell culture is well known substrate for animal rabies vaccine production

4 BHK-21 C 13 cells are much better producers of rabies virus than HDC or VERO cells…

5 Baer G.M. Improvements in Rabies Post-Exposure Treatment, Dubrovnik, Yugoslavia, 1984, pp. 15- 24: Only BHK-21 rabies vaccine induced interferon (in mice and monkeys), HDC did not!

6

7 in-house Vaccine. 2006 Mar 20; Immunogenicity and efficacy of an in-house developed cell-culture derived veterinarian rabies vaccine. Kallel H, Diouani MF, Loukil H, Trabelsi K, Snoussi MA, Majoul S, Rourou S, Dellagi K. Unite de Developpement de Vaccins Virologiques, Institut Pasteur, 13 Place Pasteur, BP 74, 1002 Belvedere, Tunis, Tunisia. The efficiency of an inactivated tissue culture rabies vaccine produced on BHK-21 cells, according to an in-house developed process, was evaluated and compared to a commercial cell-tissue culture vaccine (Rabisin). Fifteen experimental dogs from local common breed were duly conditioned during a quarantine period, then vaccinated via the subcutaneous route with 1ml of either the tissue culture vaccine developed in- house or the commercial vaccine Rabisin. The immune response of each dog was monitored for 162 days. Serum-neutralizing antibodies titers to rabies virus were determined by the rapid fluorescent focus inhibition test (RFFIT) which confirmed the strong response of dogs to both vaccines except one dog in the Rabisin group... Kallel HDiouani MFLoukil HTrabelsi KSnoussi MAMajoul SRourou S Dellagi K … and rabies vaccine production is possible in local institutes…

8 … but up today only for animals. If a BHK vaccine is good for animals for many years of experience, is this vaccine good for humans too? Its a question of the WHO and we have the first answer from late professor Sureau… Nero

9 Sureau P. Recent Data on Human Immunization Agains Rabies. Symposium on Rabies, Novi Sad, 17-19th April, 1991 At that time, professor Sureau wrote very carefully:

10 Yes, we regularly induced tumor on the inoculation site of suspension of BHK – 21 cell culture, but…

11 … tumor is solitary, enormous, and never produced metastases.

12 Tumor cells are very similar as BHK 21 C 13 in vitro,

13 Summary of tumorigenicity of BHK- 21 C 13 cell culture This tumor have not the first and most important criteria for malignancy – metastases formation! This tumor have not the first and most important criteria for malignancy – metastases formation! BHK-21 cells are tumorigenic only for hamsters (except nude mice)! BHK-21 cells are tumorigenic only for hamsters (except nude mice)! Only whole live cells are tumorigenic, not DNA, or cell extracts – Its a transplantation of cells! Only whole live cells are tumorigenic, not DNA, or cell extracts – Its a transplantation of cells! Conclusion: BHK tumor is in vivo culture of BHK-21 C 13 cells! Conclusion: BHK tumor is in vivo culture of BHK-21 C 13 cells! Hypothesis: Immunologicaly, hamsters do not recognize BHK-21 cells as tumorigenic! Becouse of, transplant growing to enormously tumor masses. Hypothesis: Immunologicaly, hamsters do not recognize BHK-21 cells as tumorigenic! Becouse of, transplant growing to enormously tumor masses.

14 DNA contamination? Inactivation of DNA by beta-propiolactonePerrin P, Morgeaux S. Inactivation of DNA by beta-propiolactone. Biologicals 1995, 23, 207-211. Product may be considered safeProduct may be considered safe on the basis of … the possible inactivation of any biological activity of contaminating DNA during processing… WHO TRS 878, Geneva, 1998, p. 26.

15 We accepted their opinions and started with en- house rabies vaccine production in Pasteur Institute in Novi Sad, Serbia, for human use, named YU BHK Rabivak.

16 Vaccine was attested in the National Center for Epidemiology Johan Bela in Budapest, a WHO accredited Laboratory for vaccine control, under supervision of Imre Lontai, MD, Ph.D., Head of Rabies Laboratory in 2001 year, and also in…

17 …Russian Academy of Medical Science Institute named by M.P. Chumakhov, under supervision of professor V.P. Grachev, and the result of vaccine potency was over 2,5 IU/ml The first lot of vaccine was re-attested after 5 years storage at +4 and had 2.6 IU/ml 2.6 IU/ml 5 th July 2006

18 Clinicaly examination on volunteers Research staff of Pasteur Institute in Novi Sad (mainly are microbiologists), External collaborators included an expert in vaccine control and few veterinarians, Hunters All received: Three doses of vaccine in days 0, 7, 21; 99/100 had antibody titre over 0,5 IU by RFFIT after 30 days; 1/100 received one additional dose and than have titre over 0,5 IU.

19 Petricciani J.C. What will happened if BHK-21 cell culture rabies vaccine is used on humans? If such vaccines, which cost as little as 0.50 dollars per dose in USA, could be used for human beings, the result would be an enormous reduction in (rabies) morbidity…If such vaccines, which cost as little as 0.50 dollars per dose in USA, could be used for human beings, the result would be an enormous reduction in (rabies) morbidity… Petricciani J.C. Ongoing tragedy of rabies. Lancet Vol 342, October 30, 1993, p. 1067.

20 Fourteen years are not enough that responsible persons accepted this proofs, but… At this moment, I believe that time for vaccine production on BHK-21 cells for human use, not only for rabies, is very close. Thank you for attention!


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