Safety and Immunogenicity of ETHIORAB Rabies Vaccine

Tegbaru, Birhanu Hurisa Belete; Mengesha, Dagmar Nolkes Abebe

doi:10.4172/2157-7560.1000195

Cited by 3 publications

(1 citation statement)

References 22 publications

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“…Rabies vaccines produced in mammalian neural tissues have the disadvantages of causing severe adverse reaction [6][7], at a rate estimated as 0.3 to 0.8 per thousand treated patients. World Health Organization (WHO) has recommended since the 90's that they have to be replaced by vaccines produced in substrates free from animal nervous tissues, as the later are more immunogenic, safe and potent vaccines produced by cell culture techniques are available and used for pre and post exposure prophylaxis [8][9]. The use of cell culture derived vaccines should meet the quality requirements of world health organization guidelines and necessary steps to be followed during purification of the vaccine to reduce the contaminants like residual cellular DNA, test for pyrogenic substances and other cellular proteins [5].…”

Section: Issn: 2638-1966mentioning

confidence: 99%

Rabies vaccine purification using HPLC, Estimation of residual vero cellular DNA by RT-PCR and potency analysis

Sekar¹,

Premkumar²,

Mohan³

et al. 2019

Madridge J Vaccines

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The rabies is a highly fatal, viral zoonotic disease can be preventable by effective vaccination. The anti-rabies vaccine prepared by cell culture technology are safer than the nerves tissue vaccine. The PV-11 strain of rabies virus was propagated in vero cells and subjected for purification using HPLC and potency analysis in this study. The viral harvest were concentrated up to 10X by tangential flow ultra-filtration with 100 kDa MWCO cassettes. The vero cell DNA in the concentrated material were removed by protamine sulfate precipitation and the virus inactivated by β propiolactone. The inactivation of virus was assured through Avirulece test, virus amplification test and PCR. The vero cell DNA in different stages of vaccine preparation were quantified by real time -PCR. It was estimated that maximum of 94.85 pg in viral harvest, 119.4 pg in concentrated material and 23.6 pg in final purified vaccine. The rabies viral protein was detected through HPLC analytical column in comparison with the international standard reference vaccine and purified by preparative column. Further dot blot hybridization assay was performed to quantify the rabies viral protein. The purified preparation was sterile filtrated through 0.22µ filtration, formulated with two different preservative and stabilizers. The final vaccine was lyophilized in vials under aseptic condition, subjected for NIH Potency analysis in mice model to estimate the potency unit of our vaccine preparation and the potency units were calculated using the probit analysis software in comparison with international standard reference vaccine. The potency unit of 4 different samples from two different formulations were measured. The potency unit of batch 1 formulations were 5.72 and 6.34 IU/ single dose and batch 2 formulations were 2.80 and 2.89 IU/ single dose. Both the vaccines passes the minimum requirement of 2.5 IU/single dose.

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Section: Issn: 2638-1966mentioning

confidence: 99%

Rabies vaccine purification using HPLC, Estimation of residual vero cellular DNA by RT-PCR and potency analysis

Sekar¹,

Premkumar²,

Mohan³

et al. 2019

Madridge J Vaccines

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Challenges and Prospects of Anti-Rabies Vaccines Production in Nigeria

Nwosu¹

2013

J Vaccines Vaccin

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Rabies is one of the oldest known viral zoonosis and remains a serious public health hazard, especially in the developing countries. It is the major viral disease in humans living in the tropics, but it is enzootic worldwide. Though its hundred percent preventable, it is estimated to cause 55,000 deaths annually, at a minimum, because appropriate therapy and preventive measures are not available in most developing countries. Exposure to rabid dogs is responsible for about 90% of reported cases of human rabies in the world each year. Effective control, prevention and eradication of rabies in man and animal can only be realized by immunization. Despite concerted efforts to develop and produce anti-rabies vaccines for protection of man and animal against rabies since 1919 in Nigeria, successful achievement of effective control and prevention of the disease through vaccination is greatly hampered by poor or lack of modern technology and facilities required for development and production of safe and effective vaccines. High cost of development and production, poor electric power supply, poor policy implementation by governments, poverty and gross lack of awareness are other major constraints encountered in rabies vaccinology in developing counties including Nigeria. Recent advances in tissue culture technologies, genetic engineering and peptide chemistry have made it possible to design and produce large quantities of pure antigens. This is a far reaching prospects for the development and production of life-saving vaccines for humans and animals. This approach aims at development and production of safe, effective, potent, and inexpensive anti-rabies vaccines with longer shelf life, greater quantity in terms of volume of vaccines produced and short immunization schedule than the trial and error approach by which vaccines were developed, produced and used in the past.

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Ancient Diseases-Microbial Impact

Earla¹

2014

J Anc Dis Prev Rem

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There are several diseases in ancient days, to which people got affected, suffered and died too. These ancient diseases caused by microbes are divided into sub categories depending up on the source through which they have affected people. Those are Food and water borne diseases, air borne diseases, vector borne diseases, etc. Although we got succeeded in curing these ancient diseases, by the grace of medicines and antibiotics, microbes are still emerging day by day by showing many mutations and have becoming an ever green challenge to the present scientific community.

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Safety and Immunogenicity of ETHIORAB Rabies Vaccine

Cited by 3 publications

References 22 publications

Rabies vaccine purification using HPLC, Estimation of residual vero cellular DNA by RT-PCR and potency analysis

Rabies vaccine purification using HPLC, Estimation of residual vero cellular DNA by RT-PCR and potency analysis

Challenges and Prospects of Anti-Rabies Vaccines Production in Nigeria

Ancient Diseases-Microbial Impact

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