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Live oral poliovirus vaccines and simian cytomegalovirus
Ana M Sierra-Honigmann1, Philip R Krause
1Center for Biologics Evaluation and Research, Food and Drug Administration, Building 29A, Rm 1C16, 29 Lincoln Drive, Bethesda, MD 20892, USA.
Abstract:
Live oral poliovirus vaccines (OPV) are often produced in primary Cercopithecus monkey kidney (CMK) cells. The kidneys of these monkeys are often latently infected with simian cytomegalovirus (SCMV), and CMK cultures are frequently contaminated with SCMV. We tested human, monkey and rabbit tissue culture systems, and found that MRC-5 cells are most sensitive for detection of SCMV. To address the question of whether OPV could be contaminated with infectious SCMV, we inoculated MRC-5 cells with neutralized OPV manufactured in the United States between 1972 and 1998. Infectious SCMV was not found in any of the vaccine lots tested. We also used the polymerase chain reaction (PCR) to search for SCMV DNA in live oral poliovirus vaccines; SCMV DNA sequences were found in several of the vaccine lots manufactured prior to 1992.
Insights
Live oral poliovirus vaccines (OPV) produced in monkey kidney cells were tested for simian cytomegalovirus (SCMV). Infectious SCMV was not detected, but SCMV DNA was found in older OPV lots.
Area of Science:
- Virology
- Vaccine Manufacturing
- Cell Culture Technology
Background:
- Live oral poliovirus vaccines (OPV) are commonly manufactured using primary Cercopithecus monkey kidney (CMK) cells.
- CMK cells are susceptible to latent simian cytomegalovirus (SCMV) infection and contamination.
- Ensuring vaccine safety necessitates investigating potential viral contaminants like SCMV in OPV.
Purpose of the Study:
- To determine if live oral poliovirus vaccines (OPV) are contaminated with infectious simian cytomegalovirus (SCMV).
- To assess the presence of SCMV DNA in OPV using molecular methods.
Main Methods:
- Testing of various tissue culture systems, including human MRC-5 cells, for SCMV detection sensitivity.
- Inoculation of sensitive MRC-5 cells with neutralized OPV batches manufactured between 1972 and 1998.
- Polymerase chain reaction (PCR) analysis to detect SCMV DNA sequences in OPV samples.
Main Results:
- MRC-5 cells demonstrated the highest sensitivity for detecting SCMV across tested systems.
- No infectious SCMV was isolated from any of the tested OPV lots.
- SCMV DNA sequences were detected in several OPV lots manufactured before 1992.
Conclusions:
- Live oral poliovirus vaccines manufactured in the US between 1972 and 1998 were not found to be contaminated with infectious simian cytomegalovirus.
- The presence of SCMV DNA in older OPV lots suggests potential historical contamination or shedding, warranting continued monitoring.
- The study validates the safety of current OPV production regarding SCMV contamination.