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news.Data from a series of preclinical studies has provided additional evidence of the safety and efficacy of an attenuated smallpox vaccine being developed by VaxGen.
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The purpose of the studies was to compare the safety of VaxGen’s attenuated vaccine candidate, LC16m8, with that of the unattenuated Lister strain of the vaccine, from which LC16m8 is derived. Lister vaccine was used in the World Health Organization’s successful smallpox eradication program.
“Results from these studies continue to support our belief that LC16m8 could provide a safer, yet effective alternative to conventional smallpox vaccines,” said Dr Marc Gurwith, VaxGen’s chief medical officer.
In a study of severe combined immune deficient (SCID) mice, a model for the compromised immune system, all mice that received Lister died while all mice that received LC16m8 survived as of 28 days after vaccination. The mean survival time for mice that received Lister was 14 days.
In another study, a much higher concentration of LC16m8 than Lister vaccine virus was required to cause erythema, or skin irritation/redness, indicating that LC16m8 may be better tolerated at the vaccination site.
LC16m8 was also shown to be less likely than Lister vaccine to cause infection or inflammation of the central nervous system, in both adult and suckling mouse models. In the adult mice, 67% of those that received Lister died, while all animals that received LC16m8 survived. In suckling mice, those that received LC16m8 survived nearly three times as long as those that received the Lister vaccine.
VaxGen is developing LC16m8 for the US and elsewhere in partnership with Kaketsuken.