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Published on: November 1, 2011
Genotypes of pestivirus RNA detected in live virus vaccines for human use
M Giangaspero1, G Vacirca, R Harasawa
1Institute of Special Pathology and Veterinary Medical Clinic, Faculty of Veterinary Medicine, The University of Milan, Italy.
Abstract:
Live virus vaccines for human use, 29 monovalent vaccines against measles, mumps, rubella or polio, eight polyvalent vaccines against measles-mumps-rubella and one bacterial polyvalent vaccine against Streptococcus pneumoniae, were tested by reverse transcriptase-nested PCR for the presence of petivirus or pestivirus RNA. Twenty-four samples were selected from European manufacturers, ten were from U.S.A. and four from Japan. Five (13.1%) out of 38 tested samples were positive for pestivirus RNA. Three vaccines (rubella and two measles) were from Europe and two (mumps and rubella) from Japan. The 5'-untranslated genomic region of the contaminant pestivirus RNA were amplified by reverse transcription-PCR and sequenced. Analyses based on primary nucleotide sequence homology and on secondary structures, characteristic to genotypes, revealed that the cDNA sequences belonged to bovine viral diarrhea virus (BVDV). A cDNA sequence, detected from one measles sample, belonged to BVDV-1b genotype. Pestiviral cDNA detected from the Japanese mumps and rubella vaccine samples, belonged to the BVDV genotypes 1a and 1c, respectively. Analysis on two cDNA sequences detected from measles and rubella vaccine samples from Europe showed their appurtenance to a new genotype, BVDV-1d. These findings indicate that contamination by animal pestivirus may occur in biological products for human use.
Insights
Live virus vaccines were tested for pestivirus contamination. Five vaccines contained bovine viral diarrhea virus (BVDV) RNA, indicating potential animal virus contamination in human biological products.
Area of Science:
- Virology
- Vaccinology
- Molecular Biology
Background:
- Live virus vaccines are critical for human health.
- Ensuring the safety and purity of vaccines is paramount.
- Potential contamination of biological products with adventitious agents is a concern.
Purpose of the Study:
- To detect pestivirus RNA in human live virus vaccines.
- To characterize the pestivirus genotypes found in contaminated vaccines.
- To assess the risk of animal virus contamination in human vaccines.
Main Methods:
- Reverse transcriptase-nested PCR was used to screen vaccines for pestivirus RNA.
- RT-PCR products were sequenced to identify pestivirus genotypes.
- Sequence homology and secondary structure analyses were performed for genotyping.
Main Results:
- Five out of 38 tested vaccines (13.1%) were positive for pestivirus RNA.
- Contaminant pestivirus RNA sequences belonged to bovine viral diarrhea virus (BVDV).
- Identified BVDV genotypes included BVDV-1a, BVDV-1b, BVDV-1c, and a novel BVDV-1d genotype.
Conclusions:
- Pestiviral RNA, specifically BVDV, was detected in several live virus vaccines for human use.
- This indicates a potential route for animal virus contamination in biological products.
- Vaccine manufacturers must implement rigorous screening to prevent such contaminations.
