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Biologicals • July 2012<br />

Investigation of porcine circovirus<br />

contamination in human vaccines<br />

Author Information<br />

Sarah M. Gillilanda, Lindsay Forresta,<br />

Heather Carrea, Adrian Jenkinsb, Neil Berryb,<br />

Javier Martina, Philip Minora, Silke Schepelmanna,<br />

Abstract<br />

DNA from porcine circovirus type 1 (PCV1) and 2 (PCV2) has recently<br />

been detected in two vaccines against rotaviral gastroenteritis from manufacturers<br />

A and B. We investigated if PCV1 sequences are present in<br />

other viral vaccines. We screened seeds, bulks and final vaccine preparations<br />

from ten manufacturers using qRT-PCR. We detected 3.8 × 103<br />

to 1.9 × 107 PCV1 DNA copies/milliliter in live poliovirus seeds for inactivated<br />

polio vaccine (IPV) from manufacturer A, however, following<br />

inactivation and purification, the finished IPV was PCV1-negative. PCV1<br />

DNA was not detectable in live polio preparations from other vaccine<br />

producers. There was no detectable PCV1 DNA in the measles, mumps,<br />

rubella and influenza vaccines analysed including material supplied by<br />

manufacturer A. We confirmed that the PCV1 genome in the rotavirus<br />

vaccine from manufacturer A is near full-length. It contains two mutations<br />

in the PCV cap gene, which may result from viral adaptation to Vero<br />

cells. Bulks of this vaccine contained 9.8 × 1010 to 1.8 × 1011 PCV1<br />

DNA copies/millilitre and between 4.1 × 107 and 5.5 × 108 DNA copies<br />

were in the final doses. We found traces of PCV1 and PCV2 DNA in the<br />

rotavirus vaccine from manufacturer B. This highlights the issue of vaccine<br />

contamination and may impact on vaccine quality control.<br />

“We found traces of PCV1 and PCV2 DNA<br />

in the rotavirus vaccine from<br />

manufacturer B. This highlights the<br />

issue of vaccine contamination and may<br />

impact on vaccine quality control.”<br />

http://www.sciencedirect.com/science/article/pii/S1045105612000267

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