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Biotech / Medical : VD's Model Portfolio & Discussion Thread
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To: Pseudo Biologist who wrote (1947)8/12/1997 12:34:00 AM
From: Pseudo Biologist   of 9719
 
To go into more detail on the fourth abstract of T's post re. Aviron:

Live attenuated, cold-adapted (ca) monovalent and bivalent influenza A vaccines were evaluated in seronegative infants (ages 6-18 months) in a double-blind placebo-controlled trial to assess safety and immunogenicity.
>> note "safety and immogenicity"- this is really a phase I-like study. The design did not have the power to assess efficacy. Conclusions about the latter are not really justified.

A total of 182 seronegative subjects received a single intranasal dose (10(6.2) TCID50) of ca A/Kawasaki/9/86 (H1N1) or ca A/Los Angeles/2/87 (H3N2), both as a bivalent vaccine, or placebo.
>> again, just 182 patients. I think the phase III recently described involved TWO intranasal doses for most cases.

Hemagglutination antibody seroconversions to H3N2 exceeded 90%. In contrast, seroconversions to A/Kawasaki/9/86 (H1N1) were significantly less frequent in bivalent ca vaccine recipients (31%) than in monovalent ca H1N1 recipients (83%) (P .002).
>> this is interesting and suggests the H3N2 variant is more immunodominant. Not sure how/if recent trial used this information.

During a subsequent H3N2 epidemic, nasal washes were cultured for viruses from any subject with respiratory illness. H3N2 infections documented by virus isolation were reduced by 65% in ca H3N2 recipients compared with placebo or ca HIM recipients (P = .01).
>> this is still significant (P = 0.01) but certainly not as impressive as the results of the trial DESIGNED to show efficacy (by using a much larger population for starters).

PB
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