Influenza A (H1N1) 2009 two-dose immunization of US children: An observer-blinded, randomized, placebo-controlled trial

Plennevaux, Eric; Blatter, Mark M.; Cornish, Matthew; Go, Kerry W.; Kirby, Daniel; Wali, Mostafa; Reeves-Hoché, Mary-Kate; Denis, Martine

doi:10.1016/j.vaccine.2010.12.116

Cited by 27 publications

(26 citation statements)

References 14 publications

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“…Monovalent, inactivated, non-adjuvanted pandemic 2009 influenza A (H1N1) vaccines have been evaluated in the general population [21], [22], [23], [24]. Randomized placebo-controlled trials have demonstrated that these vaccines are safe and widely immunogenic, with seroprotection rates among healthy adults, adolescents, and the elderly ranging from 94–98%, 94–97%, and 79–93%, respectively, after a single dose of 15 µg of antigen, and greater than 98% among healthy children, after two doses of 15 µg of antigen.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity and Reactogenicity of 2009 Influenza A (H1N1) Inactivated Monovalent Non-Adjuvanted Vaccine in Elderly and Immunocompromised Patients

et al. 2011

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BackgroundImmunosuppressed individuals present serious morbidity and mortality from influenza, therefore it is important to understand the safety and immunogenicity of influenza vaccination among them.MethodsThis multicenter cohort study evaluated the immunogenicity and reactogenicity of an inactivated, monovalent, non-adjuvanted pandemic (H1N1) 2009 vaccine among the elderly, HIV-infected, rheumatoid arthritis (RA), cancer, kidney transplant, and juvenile idiopathic arthritis (JIA) patients. Participants were included during routine clinical visits, and vaccinated according to conventional influenza vaccination schedules. Antibody response was measured by the hemagglutination-inhibition assay, before and 21 days after vaccination.Results319 patients with cancer, 260 with RA, 256 HIV-infected, 149 elderly individuals, 85 kidney transplant recipients, and 83 with JIA were included.The proportions of seroprotection, seroconversion, and the geometric mean titer ratios postvaccination were, respectively: 37.6%, 31.8%, and 3.2 among kidney transplant recipients, 61.5%, 53.1%, and 7.5 among RA patients, 63.1%, 55.7%, and 5.7 among the elderly, 59.0%, 54.7%, and 5.9 among HIV-infected patients, 52.4%, 49.2%, and 5.3 among cancer patients, 85.5%, 78.3%, and 16.5 among JIA patients. The vaccine was well tolerated, with no reported severe adverse events.ConclusionsThe vaccine was safe among all groups, with an acceptable immunogenicity among the elderly and JIA patients, however new vaccination strategies should be explored to improve the immune response of immunocompromised adult patients. (ClinicalTrials.gov, NCT01218685)

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Section: Discussionmentioning

confidence: 99%

Immunogenicity and Reactogenicity of 2009 Influenza A (H1N1) Inactivated Monovalent Non-Adjuvanted Vaccine in Elderly and Immunocompromised Patients

et al. 2011

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“…Some evidence in the published literature shows that 1 dose might have provided some protection (37). …”

Section: Methodsmentioning

confidence: 99%

Effects of Vaccine Program against Pandemic Influenza A(H1N1) Virus, United States, 2009–2010

Borse¹,

Shrestha²,

Fiore³

et al. 2013

Emerg. Infect. Dis.

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“…After a single dose, 72% of HIV-uninfected children had HAI titers 40; however, only 26% of HIV-uninfected children had baseline HAI titers 40 compared with 45% in HIV-infected children in the current study. In another study of HIV-uninfected children, aged 6 months to 9 years, vaccinated with 15 µg per dose of the same vaccine given to Group C in the current study, 62% had a titer 40 after the first dose [19]. However, only 3%-8% of these HIV-uninfected children had detectable HAI antibody to 2009 H1N1 at baseline.…”

Section: Discussionmentioning

confidence: 42%

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

Pass

Nachman²,

Flynn

et al. 2013

Journal of the Pediatric Infectious Diseases Society

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Background. With 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. Methods. A 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. Results. One 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. Conclusions. Although 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.

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Influenza A (H1N1) 2009 two-dose immunization of US children: An observer-blinded, randomized, placebo-controlled trial

Cited by 27 publications

References 14 publications

Immunogenicity and Reactogenicity of 2009 Influenza A (H1N1) Inactivated Monovalent Non-Adjuvanted Vaccine in Elderly and Immunocompromised Patients

Immunogenicity and Reactogenicity of 2009 Influenza A (H1N1) Inactivated Monovalent Non-Adjuvanted Vaccine in Elderly and Immunocompromised Patients

Effects of Vaccine Program against Pandemic Influenza A(H1N1) Virus, United States, 2009–2010

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

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