AbstractThe aim of this study is to further investigate the immune response of the inactivated split-virion vaccine for infants. We tested the immunogenicity and safety of the inactivated split-virion vaccine in infants, aged 6–35 months, for a randomized, observer-masked, age-stratified clinical study. We randomly divided subjects into three groups: 7.5 μg, 15 μg of hemagglutinin antigen dosage groups and seasonal influenza vaccine for children dosage group in a 2 dose regimen. A serologic analysis was performed at baseline and on day 21 and 42. 312 infants received a single dose injection of vaccine and 265 (84.94%) infants received two doses injection of vaccine. Adverse reactions were mostly mild or moderate. Among the subjects who received 7.5 μg and 15 μg of vaccine for a single dose injection, the rate of hemagglutinin inhibition titer of 1:40 or greater were 52.48% (95% confidence interval (CI) 42.83 ~ 61.95) and 61.11% (95% CI 50.78 ~ 70.53), respectively. Among the subjects receiving 7.5 μg and 15 μg of vaccine for two doses injection, the rate of hemagglutinin inhibition (HI) titer of 1:40 or greater were 90.10% (95% CI 82.73 ~ 94.53) and 94.44% (95% CI 87.64 ~ 97.60), respectively. These data suggests that 15 μg or 7.5 μg dose of hemagglutinin antigen of the inactivated split-virion vaccine was safe and two doses of injection could induce a sufficient protective immune response in infants.Trial registrationClinical trials registration:NCT01494740.

2013-12-01·Journal of the Pediatric Infectious Diseases Society3区 · 医学

Immunogenicity of Licensed Influenza A (H1N1) 2009 Monovalent Vaccines in HIV-Infected Children and Youth

3区 · 医学

Article

作者: Robert F. Pass ; L. Jill Utech ; Terence Fenton ; Patricia M. Flynn ; Wende Levy ; George K. Siberry ; Elizabeth Petzold ; William Borkowsky ; Coleen K. Cunningham ; Ed Handelsman ; Petronella Muresan ; Stephen A. Spector ; Sharon Nachman ; James B. McAuley ; Adriana Weinberg

BACKGROUNDWith the emergence of pandemic influenza A (pH1N1) in 2009, children and youth infected with human immunodeficiency virus (HIV) were vulnerable because of immunologic impairment and the greater virulence of this infection in young persons.METHODSA multicenter study of the immunogenicity of 3 licensed influenza A (H1N1) monovalent vaccines (1 live attenuated and 2 inactivated) was conducted in children and youth with perinatal HIV infection, most of whom were receiving ≥3 antiretroviral drugs, had CD4% ≥15, and plasma HIV RNA levels <400 copies/mL. Serum hemagglutinin inhibition assay (HAI) antibody levels were measured and correlated with baseline demographic and clinical variables.RESULTSOne hundred forty-nine subjects were enrolled at 26 sites in the United States and Puerto Rico. Over 40% had baseline HAI titers ≥40. For subjects aged 6 months to <10 years, 79% and 68%, respectively, achieved a ≥40- and ≥4-fold rise in HAI titers after the second dose of vaccine. Three weeks after a single immunization with an inactivated vaccine, similar immunogenicity results were achieved in youth aged 10-24 years. With multivariable analysis, only Hispanic ethnicity and CD4% ≥15 were associated with achieving both HAI titer ≥40- and ≥4-fold rise in titer.CONCLUSIONSAlthough licensed pH1N1 vaccines produced HAI titers that were considered to be protective in the majority of HIV-infected children and youth, the proportion with titers ≥40- and ≥4-fold rise in titer was lower than expected for children without HIV infection. Vaccine immunogenicity was lower in HIV-infected children and youth with evidence of immune suppression.

2012-08-01·Expert Review of Vaccines2区 · 医学

Safety of seasonal influenza and influenza A (H1N1) 2009 monovalent vaccines in pregnancy

2区 · 医学

Review

作者: Moro, Pedro L. ; Vellozzi, Claudia ; Tepper, Naomi K. ; Grohskopf, Lisa A. ; Broder, Karen

Inactivated influenza vaccines have been given to pregnant women since 1964. Since 2004, the Advisory Committee on Immunization Practices has recommended that pregnant women receive trivalent inactivated influenza vaccine at any time during pregnancy. Studies conducted before 2009 did not identify any safety concerns after trivalent inactivated influenza vaccine in mothers or their infants. During the 2009-2010 influenza A (H1N1) influenza vaccination program, several monitoring systems were established or enhanced to assess whether adverse events were associated with H1N1 2009 monovalent vaccines (2009 H1N1 influenza vaccines). Data from these systems did not identify any safety concerns in pregnant women who received 2009 H1N1 influenza vaccines or their infants. Although live attenuated influenza vaccines are not recommended in pregnant women, a small number of studies have not shown any safety concern among pregnant women or their infants who were inadvertently exposed to these vaccines. This review summarizes US and international safety data for influenza vaccines in pregnant women with an emphasis on 2009 H1N1 influenza vaccines.

100 项与 Influenza A (H1N1) 2009 monovalent vaccine(MedImmune LLC) 相关的药物交易

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