Antibody responses after dose-sparing intradermal influenza vaccination.

Reduced-dose intradermal (ID) influenza vaccination is an attractive approach to increase availability of vaccine supply in an event of vaccine shortage. We conducted a randomized open-label study, in which 500 subjects were randomly assigned to receive an ID injection of 0.1 ml dose of inactivated split-virion influenza vaccine or an IM injection of 0.5 ml dose. The subjects who had hemagglutination inhibition (HI) antibody titer of at least 1:40 at day 28 post-vaccination in ID and IM groups were 93.3% versus 98.0% for influenza A(H1N1) virus, 86.3% versus 95.0% for A(H3N2) virus, and 43.5% versus 57.0% for influenza B virus. Subjects in the ID group had an increase in geometric mean titer by a factor of 16 for the H1N1 strain, 8 for the H3N2 strain, and 2 for the B strain on day 28, as compared with respective increase in the IM group of 31, 20, and 3. Local reactions were significantly more frequent among subjects in the ID group than those in the IM group, but the reactions were mild and transient. In this study, ID administration of one-fifth dose of influenza vaccine elicited significantly lower levels of antibody response as compared to full-dose IM injection. However, the antibody responses elicited by the ID vaccination were still sufficiently high to meet the requirement guidelines of the European Committee for Proprietary Medicinal Products (CPMP) for the annual relicensure of influenza vaccines.

Occurrence and protective level of influenza infections using serology in patients with COPD in vaccination study.

OBJECTIVE: To investigate the prevalence, occurrence and protective level of influenza infections using serology in patients with chronic obstructive pulmonary disease (COPD) during a one-year influenza vaccination study. MATERIAL AND METHOD: A total of 123 patients with COPD were enrolled during the period of 1997 to 1998. There were 61 patients in the vaccine group and 62 patients in the placebo group with a mean age +/- SD of 67.6 +/- 8.0 and 69.1 +/- 7.5, respectively. The vaccine was composed of influenza A/Texas/36/91 (H1N1), A/Nanchang/933/95 (H3N2) and B/Harbin/07/94 strains. Antibodies to influenza viruses were detected by hemagglutination inhibition (HI) test using antigens of vaccine strains. RESULTS: The incidence of influenza proven by serological examination was 22/123 (17.9%) cases. Among 17/62 (27.4%) influenza cases in the placebo group representing natural infections, 3 (17.6%) were diagnosed as A (H1N1), 8 (47.1%) as A (H3N2), 3 (17.6%) as type A, 1 (5.9%) as type B and 2 (11.8%) as untypeable viruses. The 8.2% of influenza cases found in the vaccine group was significantly lower than 27.4% of that in the placebo group (Chi-square test, p = 0.01). The protection rate of influenza vaccination was 71%. Among 23 acute blood samples from 22 influenza cases, the titers ranged from < 10 to 20 corresponding to its type/subtype. In the vaccine group, 5 influenza cases occurred at 7, 7, 10, 11 and 11 months after vaccination. The HI antibodies to influenza A (H1N1), A (H3N2) and B viruses at titers of > or = 10 vs > or = 40 were 50.4% vs 21.9%, 54.5% vs 28.5% and 17.9% vs 4.1%, respectively. CONCLUSION: The findings indicated that from 1997 to 1998, the occurrence of influenza as natural infection was 27.4%. Influenza A (H3N2) was more frequently prevalent than A (H1N1) and B viruses. The influenza vaccination in COPD patients was effective. The protective HI antibody titers were > or = 40. The patients without protective HI antibody to A (H1N1), A (H3N2) and B viruses were 78.1%, 71.5% and 95.9%, respectively. Such patients were considered to be at high-risk for influenza and recommended to have vaccination.