Promising New Flu Vaccine Aces Phase I & II Trials...
The results of phase I and II trials of Baxter's new cell culture-based flu vaccine is the headliner story in this week's New England Journal of Medicine. Lots of good news:
* It takes only 12 weeks to grow the vaccine in cell culture, versus 22 weeks in fertilized chicken eggs (The culture is from a 46-year-old cell line derived from the kidneys of African Green monkeys. Just curious -- but does anybody know why a particular type of cell line is selected? Chicken egg vs. African Green monkey kidney cell? I certainly wouldn't have seen the match...)
* It protects against multiple related strains
* The virus used to develop the vaccine is virtually identical to a circulating strain, which means it's so well aimed, adjuvants aren't needed.
* Side effects are about the same as with egg vaccines: some irritation at the injection site, headaches, etc. Nothing too serious.
The only real disadvantage I can see was that it requires two shots, 21 days apart. It's hard enough to get people in for one shot. Twice is exponentially trickier. Also, I wonder whether having a population of partially-protected people could lead to the selection of new vaccine-resistant strains.
According to Baxter's website:
H5N1 Vaccine Phase III trial design
The Phase III open-label trial will evaluate the safety and immune response of the H5N1 vaccine candidate
* It takes only 12 weeks to grow the vaccine in cell culture, versus 22 weeks in fertilized chicken eggs (The culture is from a 46-year-old cell line derived from the kidneys of African Green monkeys. Just curious -- but does anybody know why a particular type of cell line is selected? Chicken egg vs. African Green monkey kidney cell? I certainly wouldn't have seen the match...)
* It protects against multiple related strains
* The virus used to develop the vaccine is virtually identical to a circulating strain, which means it's so well aimed, adjuvants aren't needed.
* Side effects are about the same as with egg vaccines: some irritation at the injection site, headaches, etc. Nothing too serious.
The only real disadvantage I can see was that it requires two shots, 21 days apart. It's hard enough to get people in for one shot. Twice is exponentially trickier. Also, I wonder whether having a population of partially-protected people could lead to the selection of new vaccine-resistant strains.
According to Baxter's website:
H5N1 Vaccine Phase III trial design
The Phase III open-label trial will evaluate the safety and immune response of the H5N1 vaccine candidate
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