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Irrespective of the CHMP criteria, it is interesting that 87.5% of the subjects who received two doses of either the 10 or 20 µg VLP vaccine mounted a detectable HI response and 95.8% mounted detectable MN responses.
The first vaccination induced an HI response in at least one subject in each group of 30 children, but titres remained low: the GMT 21 days after the first vaccination ranged from 4.29 (95% CI: 3.8 4.83) to 8.48 (95% CI: 5.34 13.5) per group.
The HI response at 30 days was characteristic of primary Flavivirus infection.
The analysis of the HI response was based on the per-protocol cohort for immunogenicity.
Reverse cumulative distribution curve of the HI response after the second dose of immunization showed similar HI response in the control group and A/Indonesia/05/2005 primed group, but a higher HI response in A/Vietnam/1194/2004 and A/Indonesia/05/2005 primed group.> -wrap-foot> aGMT = geometric mean titer.
Due to potential assay variability, a comparative interpretation of the HI response at Day 182 with earlier time points should be done with caution.
Similar(48)
When immunized sera were processed for micro-virus neutralization assays using 100 TCID50 of CA/04/09 in Madin-Darby canine kidney (MDCK) cells, administration of the reverse-genetics vaccine demonstrated efficient virus neutralizing activity which correlated comparably well with the vaccine-induced HI responses (data not shown).
There was one adult patient who could not develop significant HI antibody response (HI titer <10 and 10), although he possessed NT antibody titer of 20 and 80.
HI responses were sustained at 3 months post-immunisation in both groups.
HI responses against H1N1 strains included in vaccine formulations from 1998 to 2006 were also examined.
GLA-SE broadened HI responses and generated more virus-specific BMPCs, the hallmark of long-term humoral immunity [16], compared with SE alone.
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