TY - JOUR
T1 - Safety and immunogenicity of 2009 pandemic H1N1 influenza vaccination in perinatally HIV-1-infected children, adolescents, and young adults
AU - Flynn, Patricia M.
AU - Nachman, Sharon
AU - Muresan, Petronella
AU - Fenton, Terence
AU - Spector, Stephen A.
AU - Cunningham, Coleen K.
AU - Pass, Robert
AU - Yogev, Ram
AU - Burchett, Sandra
AU - Heckman, Barbara
AU - Bloom, Anthony
AU - Utech, L. Jill
AU - Anthony, Patricia
AU - Petzold, Elizabeth
AU - Levy, Wende
AU - Siberry, George K.
AU - Ebiasah, Ruth
AU - Miller, Judi
AU - Handelsman, Edward
AU - Weinberg, Adriana
N1 - Funding Information:
Financial support. Overall support for the IMPAACT group was provided by the National Institute of Allergy and Infectious Diseases (NIAID) (U01 AI068632), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Institute of Mental Health (AI068632). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. This work was supported by the Statistical and Data Analysis Center at the Harvard School of Public Health, under the National Institute of Allergy and Infectious Diseases (cooperative agreement number 5 U01 AI41110 with the Pediatric AIDS Clinical Trials Group and number 1 U01 AI068616 with the IMPAACT group). Support of the sites was provided by the NIAID and the NICHD International and Domestic Pediatric and Maternal HIV Clinical Trials Network funded by NICHD (contract number N01-DK-9-001/HHSN267200800001C). Potential conflicts of interest. All authors: No reported conflicts.
PY - 2012/8/1
Y1 - 2012/8/1
N2 - Background. The safety and immunogenicity of high-dose pandemic H1N1 (pH1N1) vaccination in perinatally human immunodeficiency virus type 1 (HIV-1)-infected children, adolescents, and young adults are unknown. Methods. Two 30-g doses of 2009 Novartis pH1N1 monovalent vaccine (Fluvirin) were administered 21-28 days apart to perinatally HIV-1-infected children, adolescents, and young adults. Antibodies were measured by hemagglutination inhibition (HAI) assay at baseline, 21-28 days after first vaccination, 7-13 days after the second vaccination, and 7 months after the first vaccination. Results. Among the 155 participants, 54 were aged 4-8 years, 51 were aged 9-17 years, and 50 were aged 18-24 years. After 2 doses of Fluvirin, seroresponse (≥4-fold rise in HAI titers) was demonstrated in 79.6, 84.8, and 83 of participants in the aforementioned age groups, respectively, and seroprotection (HAI titers ≥40) was shown in 79.6, 82.6, and 85.1, respectively. Of those lacking seroresponse (n = 43) or seroprotection (n = 37) after the first vaccination, 46.5 and 40.5 achieved seroresponse or seroprotection, respectively, after the second vaccination. Among participants who lacked seroprotection at entry, a "complete response" (both seroresponse and seroprotection) after first vaccination was associated with higher baseline log10 HAI titer and non-Hispanic ethnicity. No serious vaccine-related events occurred.Conclusion.Two doses of double-strength pH1N1 vaccine are safe and immunogenic and may provide improved protection against influenza in perinatally HIV-1-infected children and youth. Clinical Trials Registration. NCT00992836.
AB - Background. The safety and immunogenicity of high-dose pandemic H1N1 (pH1N1) vaccination in perinatally human immunodeficiency virus type 1 (HIV-1)-infected children, adolescents, and young adults are unknown. Methods. Two 30-g doses of 2009 Novartis pH1N1 monovalent vaccine (Fluvirin) were administered 21-28 days apart to perinatally HIV-1-infected children, adolescents, and young adults. Antibodies were measured by hemagglutination inhibition (HAI) assay at baseline, 21-28 days after first vaccination, 7-13 days after the second vaccination, and 7 months after the first vaccination. Results. Among the 155 participants, 54 were aged 4-8 years, 51 were aged 9-17 years, and 50 were aged 18-24 years. After 2 doses of Fluvirin, seroresponse (≥4-fold rise in HAI titers) was demonstrated in 79.6, 84.8, and 83 of participants in the aforementioned age groups, respectively, and seroprotection (HAI titers ≥40) was shown in 79.6, 82.6, and 85.1, respectively. Of those lacking seroresponse (n = 43) or seroprotection (n = 37) after the first vaccination, 46.5 and 40.5 achieved seroresponse or seroprotection, respectively, after the second vaccination. Among participants who lacked seroprotection at entry, a "complete response" (both seroresponse and seroprotection) after first vaccination was associated with higher baseline log10 HAI titer and non-Hispanic ethnicity. No serious vaccine-related events occurred.Conclusion.Two doses of double-strength pH1N1 vaccine are safe and immunogenic and may provide improved protection against influenza in perinatally HIV-1-infected children and youth. Clinical Trials Registration. NCT00992836.
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U2 - 10.1093/infdis/jis360
DO - 10.1093/infdis/jis360
M3 - Article
C2 - 22615311
AN - SCOPUS:84863915909
SN - 0022-1899
VL - 206
SP - 421
EP - 430
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 3
ER -