Notes

The patients in group B had significantly higher serum concentration of IgM and significantly lower serum concentration of complement C4 than the healthy carriers in group A
No differences were found between the two groups with respect to the presence of autoantibodies or the antibody response to vaccination with keyhole limpet haemocyanin. Delayed-type cutaneous reactions to 2,4-dinitrochlorobenzene, haemocyanin and PPD were equal in the two groups. l-fucose -induced lymphocyte transformation was significantly lower in the group of patients with chronic hepatitis as compared to the healthy carriers, but none of the groups showed a statistically significant difference from a control group of eight laboratory technicians. It is concluded that a general immunodeficiency state is not a prerequisite for developing persistent Au-antigenaemia. The slightly impaired T-cell response to PHA found in patients with persistent Au-antigenaemia and chronic liver disease may be related to the liver disease rather than to the vaccine in children with acute lymphoblastic leukemia. METHODS: Studies were performed in 25 patients previously vaccinated against influenza (Group A) and in 20 children who had never been immunized before (Group B).

In Autumn, 1996, they were vaccinated with subunit trivalent influenza vaccine containing 15 microg of hemagglutinin of A/Singapore/6/86, A/Wuhan/359/95 and B/Beijing(184/93. Antihemagglutinin (HI) and antineuraminidase antibody titers were determined before immunization and 3 weeks and 6 months after vaccination by the hemagglutinin inhibition test and the neuraminidase inhibition test. All results were presented as the geometric mean titer of antibodies, mean fold increase of antibody titer, protection rate and response rate. RESULTS: In Group A mean fold increase of HI antibodies ranged from 17.2 to 26.7 three weeks after vaccination and from 22.1 to 38.

2 six months after vaccination, while in Group B it ranged from 15.7 to 22.6 and from 30.3 to 39.3, respectively. In the case of neuraminidase, mean fold increases for Group A varied from 9.2 to 13.

2 three weeks after immunization and from 15.6 to 21.1 six months after vaccination, whereas for Group B they varied from 5.5 to 8.3 and from 14.4 to 23.4, respectively.

Six months after vaccination the proportion of subjects with HI antibodies > or = 1:40, as well as those with at least 4-fold increase of HI antibody titers, ranged from 68 to 100% in Group A and from 90 to 100% in Group B. No vaccinated child was infected with the influenza virus; the vaccine was well-tolerated and did not cause any adverse reactions. CONCLUSIONS: The results obtained in this study indicate that influenza vaccine is immunogenic in patients with acute lymphoblastic leukemia, despite their serious disease.10.1097/00006454-199802000-00009.a 2-year randomized controlled clinical trial.prototype human papillomavirus (HPV) 16 viruslike particle (VLP) vaccine directed against the L1 capsid protein.

SUBJECTS AND METHODS: We enrolled healthy nonpregnant women aged 18 to 26 years into a 2-year, double-blind, dose-ranging multicenter trial (October 12, 1998, to September 30, 2001). Subjects were assigned to study groups to receive a 3-dose regimen (day 0, month 2, and month 6) of 1 of 4 vaccine doses: 10 microg, 20 microg, 40 microg, or 80 microg or placebo. Serum anti-HPV 16 L1 antibody (sL1Ab) geometric mean titers (GMTs) were measured at day 0, at month 3, at month 7, and every 6 months for a total of 2 years using a radioimmunoassay. The primary immunogenicity analyses evaluated GMTs at month 7 in L1Ab-seronegative subjects at baseline. Vaccine tolerability was also assessed. RESULTS: A total of 480 subjects were randomized to receive placebo (n=52) or 10 microg (n=112), 20 microg (n=105), 40 microg (n=104), or 80 microg (n=107) of HPV 16 L1 VLP vaccine. At baseline, 75% of subjects were L1Ab seronegative.

All vaccine doses produced a statistically significant sL1Ab response vs placebo (P<.001). At the completion of the vaccination regimen, sL1Ab GMTs in baseline-seronegative subjects were 36- to 78-fold higher than the sL1Ab GMT at day 0 observed in subjects who had mounted an immune response to HPV 16 infection before enrollment. Serum L1Ab GMTs remained high throughout the 1.
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