title: Investigation of porcine circovirus contamination in human vaccines.
abstract: DNA from porcine circovirus type 1 (PCV1) and 2 (PCV2) has recently been detected in two vaccines against rotaviral gastroenteritis from manufacturers A and B. We investigated if PCV1 sequences are present in other viral vaccines. We screened seeds, bulks and final vaccine preparations from ten manufacturers using qRT-PCR. We detected 3.8 × 10³ to 1.9 × 10⁷ PCV1 DNA copies/milliliter in live poliovirus seeds for inactivated polio vaccine (IPV) from manufacturer A, however, following inactivation and purification, the finished IPV was PCV1-negative. PCV1 DNA was not detectable in live polio preparations from other vaccine producers. There was no detectable PCV1 DNA in the measles, mumps, rubella and influenza vaccines analysed including material supplied by manufacturer A. We confirmed that the PCV1 genome in the rotavirus vaccine from manufacturer A is near full-length. It contains two mutations in the PCV cap gene, which may result from viral adaptation to Vero cells. Bulks of this vaccine contained 9.8 × 10¹⁰ to 1.8 × 10¹¹ PCV1 DNA copies/millilitre and between 4.1 × 10⁷ and 5.5 × 10⁸ DNA copies were in the final doses. We found traces of PCV1 and PCV2 DNA in the rotavirus vaccine from manufacturer B. This highlights the issue of vaccine contamination and may impact on vaccine quality control.
authors.affiliation: Division of Virology, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar EN6 3QG, United Kingdom.
authors.forename: Sarah M
authors.initials: SM
authors.lastname: Gilliland
authors.forename: Lindsay
authors.initials: L
authors.lastname: Forrest
authors.forename: Heather
authors.initials: H
authors.lastname: Carre
authors.forename: Adrian
authors.initials: A
authors.lastname: Jenkins
authors.forename: Neil
authors.initials: N
authors.lastname: Berry
authors.forename: Javier
authors.initials: J
authors.lastname: Martin
authors.forename: Philip
authors.initials: P
authors.lastname: Minor
authors.forename: Silke
authors.initials: S
authors.lastname: Schepelmann
mesh_terms: D000595:Amino Acid Sequence; D001483:Base Sequence; D017925:Circovirus / Q000302:isolation & purification*; D017931:DNA Primers; D004340:Drug Contamination; D006801:Humans; D008969:Molecular Sequence Data; D023321:Poliovirus Vaccines / Q000032:analysis*; D060888:Real-Time Polymerase Chain Reaction; D020133:Reverse Transcriptase Polymerase Chain Reaction
chemical_list: D017931:DNA Primers; D023321:Poliovirus Vaccines