ZKBS risk assessment for SV40

The Betapolyomavirus macacae (synonyms: Simian virus 40 (SV40)) and Macaca mulatta polyomavirus 1 (MmPV1)), was first discovered in 1960 as a contamination in kidney cell cultures of rhesus monkeys ( Macaca mulatta ) used to produce polio vaccines. The non-enveloped B. macaca Virion contains a circular, double-stranded DNA genome that encodes nine viral proteins. One of these proteins, the large tumor antigen (T-Ag), can, under certain conditions, Immortalization or malignant transformation of infected host cells.

The natural hosts of B. macaca are monkeys, especially macaques and rhesus monkeys. In infected animals, the virus generally does not cause clinical symptoms, but in isolated cases, severe disease can occur. B. macacae can occur either indirectly through contamination of the environment or through direct contact between monkeys.

In humans, infection with B. macacae already in the 1960s after treatment with contaminated vaccines The infected individuals did not show any symptoms of disease. Due to the transforming potential of some of the viral proteins of B. macacae It was initially suspected that people treated with the contaminated vaccines might develop tumors. However, several long-term follow-up studies showed no increased risk of cancer in recipients of B. macacae -contaminated vaccines. There is also no evidence of infection with B. macacae from person to person.

According to Section 5 Paragraph 1 GenTSV in conjunction with the criteria in Annex I GenTSV, the ZKBS classifies in its current statement B. macacae as a donor and recipient organism for genetic engineering work in the Risk group 2 a. B. macacae has a broad host range and can infect not only monkeys but also humans. Infections are typically asymptomatic, but in rare cases, at least in infected monkeys, they can lead to severe cases. A low human pathogenic potential of B. macacae cannot be ruled out.

The ZKBS statement on B. macacae can be found under the File number 45242.0207 Please note that this current statement supersedes an older statement (Ref. 6790-10-34 of 1995), to which some subsequent ZKBS statements referred.