Report from the AIDS/Poliovirus Advisory Committee

CONFIDENTIAL

These cell lines should be capable of detecting most or all of the known
HIV/SIV species. Virus production should be monitored by testing for reverse
transcriptase activity in the culture medium, and by an antigen capture assay. Any
virus produced should be fully characterized.
Testing for the presence of HIV/SIV related sequences by PCR should be done
on nucleic acid extracted from vaccine stocks, possibly after a step of virus
concentration. Reverse transcriptase - PCR should be used. Primers for the
amplification of HIV/SIV related DNA should be the following.
a) Two HIV-1 specific primers (representing conserved regions of the
viral genome)
b) Two HIV-2 specific primers
c) SIVSM-SIVMAC specific primers
d) SIVAGM-specific primers
e) Two primers which could detect sequences conserved in all members
of the HIV family. The pol gene is a good candidate for this.
Any amplified DNA should be sequenced. Stringent measures should be
adopted to avoid laboratory contaminations.
In closing, we feel compelled to mention that the current controversy
highlights the problems and difficulties associated with using monkey tissue for
production of vaccines administered to humans. To this day, live-attenuated
poliovirus vaccine is produced in the United States and in most other countries
using primary African green monkey kidney cells. Although green monkeys can
now be certified free of SI for use in vaccine production, specific tests could not
have been performed prior to 1985 when SI was first isolated. There may well be
other monkey viruses that have not yet been discovered that could possibly
contaminate vaccine lots. This provides a powerful argument for the use of wellcharacterized cell lines for vaccine production. A continuous cell line can be
intensely scrutinized prior to certification for use in vaccine production. It could be
argued that the live polio vaccine produced in primary monkey kidney culture is
extremely safe and effective and that tampering with the mode of production could
result in diminished safety or efficacy. However, at least one major European
manufacturer has recently gone to using a cell line and is apparently producing a
safe and effective live vaccine with this method. A serious effort is needed in the

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