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BHK-21 cell culture rabies vaccine: immunogenicity of a candidate vaccine for humans.
Dev Biol (Basel). 2008; 131:421-9.DB

Abstract

Veterinary rabies vaccines produced in BHK-21/C13 permanent cell cultures have been used for a long period of time and have been proven as efficacious and safe. A candidate vaccine for human use (YU BHK Rabivak) was developed at the Pasteur Institute, Novi Sad, Serbia on the basis of the fixed rabies virus strain "L. Pasteur 2061/Vero 15 pas" using BHK 21/C13 as a cell substrate for vaccine production. To test the vaccine immunogenicity, a clinical trial was conducted involving 164 subjects between 18 and 60 years of age, immunized either with the YU BHK Rabivak vaccine candidate orwith a commercially available vaccine (Rabipur). Three groups of subjects were immunized with either vaccine by intramuscular administration in the deltoid region, following a pre-exposure regimen on days 0, 7 and 21, or the Essen or Zagreb post-exposure regimens. Rabies virus neutralizing antibodies (VNA) titres were determined by rapid fluorescent focus inhibition test (RFFIT) 21 and 30-45 days post vaccination. A protective titre of VNAs (>0.5 IU/ml) was found in all subjects vaccinated. Dynamics of the immune response showed that 96.4% of the subjects developed protective VNA titres after two doses, 99.3% after three doses and 100% after four and five doses of the candidate YU BHK Rabivak vaccine. There was a low reactogenicity without serious adverse events indicating a satisfactory safety profile in humans. Results obtained in this study indicate that BHK 21 cells offer the possibility of producing an efficacious and safe cell-culture rabies vaccine for humane use.

Authors+Show Affiliations

Faculty of Medicine, Pasteur Institute, Novi Sad, Serbia. pasteuri@eunet.yuNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18634504

Citation

Lalosević, D, et al. "BHK-21 Cell Culture Rabies Vaccine: Immunogenicity of a Candidate Vaccine for Humans." Developments in Biologicals, vol. 131, 2008, pp. 421-9.
Lalosević D, Lalosević V, Lazarević-Ivanc Lj, et al. BHK-21 cell culture rabies vaccine: immunogenicity of a candidate vaccine for humans. Dev Biol (Basel). 2008;131:421-9.
Lalosević, D., Lalosević, V., Lazarević-Ivanc, L. j., & Knezević, I. (2008). BHK-21 cell culture rabies vaccine: immunogenicity of a candidate vaccine for humans. Developments in Biologicals, 131, 421-9.
Lalosević D, et al. BHK-21 Cell Culture Rabies Vaccine: Immunogenicity of a Candidate Vaccine for Humans. Dev Biol (Basel). 2008;131:421-9. PubMed PMID: 18634504.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - BHK-21 cell culture rabies vaccine: immunogenicity of a candidate vaccine for humans. AU - Lalosević,D, AU - Lalosević,V, AU - Lazarević-Ivanc,Lj, AU - Knezević,I, PY - 2008/7/19/pubmed PY - 2008/10/2/medline PY - 2008/7/19/entrez SP - 421 EP - 9 JF - Developments in biologicals JO - Dev Biol (Basel) VL - 131 N2 - Veterinary rabies vaccines produced in BHK-21/C13 permanent cell cultures have been used for a long period of time and have been proven as efficacious and safe. A candidate vaccine for human use (YU BHK Rabivak) was developed at the Pasteur Institute, Novi Sad, Serbia on the basis of the fixed rabies virus strain "L. Pasteur 2061/Vero 15 pas" using BHK 21/C13 as a cell substrate for vaccine production. To test the vaccine immunogenicity, a clinical trial was conducted involving 164 subjects between 18 and 60 years of age, immunized either with the YU BHK Rabivak vaccine candidate orwith a commercially available vaccine (Rabipur). Three groups of subjects were immunized with either vaccine by intramuscular administration in the deltoid region, following a pre-exposure regimen on days 0, 7 and 21, or the Essen or Zagreb post-exposure regimens. Rabies virus neutralizing antibodies (VNA) titres were determined by rapid fluorescent focus inhibition test (RFFIT) 21 and 30-45 days post vaccination. A protective titre of VNAs (>0.5 IU/ml) was found in all subjects vaccinated. Dynamics of the immune response showed that 96.4% of the subjects developed protective VNA titres after two doses, 99.3% after three doses and 100% after four and five doses of the candidate YU BHK Rabivak vaccine. There was a low reactogenicity without serious adverse events indicating a satisfactory safety profile in humans. Results obtained in this study indicate that BHK 21 cells offer the possibility of producing an efficacious and safe cell-culture rabies vaccine for humane use. SN - 1424-6074 UR - https://www.unboundmedicine.com/medline/citation/18634504/BHK_21_cell_culture_rabies_vaccine:_immunogenicity_of_a_candidate_vaccine_for_humans_ L2 - http://www.diseaseinfosearch.org/result/6131 DB - PRIME DP - Unbound Medicine ER -