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Vaccine
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doi:10.1016/j.vaccine.2011.11.105 | How to Cite or Link Using DOI
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Immunogenicity and safety of inactivated monovalent 2009 H1N1 influenza A vaccine in immunocompromised children and young adults
Hana Hakima, Corresponding Author Contact Information, E-mail The Corresponding Author, Kim J. Allisona, Lee-Ann Van De Veldea, Yimei Lib, Patricia Flynna, Jonathan A. McCullersa
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a Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, United States
b Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, United States
Received 13 September 2011; revised 22 November 2011; Accepted 25 November 2011. Available online 9 December 2011.
Abstract
Background
Influenza vaccination is recommended for immunocompromised patients.
Methods
Children (6 months to 21 years) with cancer, HIV infection, or sickle cell disease (SCD) received 1 or 2 doses of pandemic 2009 H1N1 monovalent influenza vaccine (H1N1 MIV). Safety and tolerability, hemagglutination inhibition (HI) and microneutralization (MN) antibody titers were measured against 2009 H1N1 influenza A virus after each dose. Seroprotection (SP) and seroconversion (SC) rates were determined.
Results
103 participants were enrolled and 99 were evaluable (39 with HIV, 37 with cancer and 23 with SCD). Mean age (?SD) was 7.9 (?5.4) years for cancer participants, 18.0 (?3.5) for HIV, and 13.3 (?4.2) for SCD. 54% were males; 65% black; and 96% had received seasonal influenza vaccine. HIV-infected participants had a median CD4 count of 625 cells/mm3 (range, 140?1260). 46% had an undetectable HIV viral load and 41% were perinatally infected. No participant had vaccine-related serious adverse events. None developed influenza A proven illness during the 6 months after the vaccine. Local injection reactions were reported in 29% and systemic reactions in 42% after the first dose of vaccine. SC and SP were achieved after the last dose in 48% and 52%, respectively, of participants with leukemia or lymphoma, 50% and 75% of participants with solid tumors, 63% and 92% of HIV-infected participants, and 74% and 100% of participants with SCD.
Conclusion
H1N1 MIV was safe and well tolerated. H1N1 MIV resulted in an adequate immune response in children with SCD. It was only modestly immunogenic in cancer or HIV participants.
Highlights
► In 2009, an H1N1 monovalent influenza vaccine was recommended in addition to the seasonal vaccine. ► We evaluated the immunogenicity and safety of H1N1 influenza vaccine in immunocompromised children. ► The H1N1 vaccine was safe and well tolerated in children with cancer, HIV, and sickle cell disease. ► The H1N1 vaccine resulted in an adequate immune response in children with sickle cell disease. ► The H1N1 vaccine was only modestly immunogenic in children with cancer or HIV infection.
http://www.sciencedirect.com/science/article/pii/S0264410X11019013
In Press, Uncorrected Proof - Note to users
doi:10.1016/j.vaccine.2011.11.105 | How to Cite or Link Using DOI
Permissions & Reprints
Immunogenicity and safety of inactivated monovalent 2009 H1N1 influenza A vaccine in immunocompromised children and young adults
Hana Hakima, Corresponding Author Contact Information, E-mail The Corresponding Author, Kim J. Allisona, Lee-Ann Van De Veldea, Yimei Lib, Patricia Flynna, Jonathan A. McCullersa
Purchase
a Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, United States
b Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, United States
Received 13 September 2011; revised 22 November 2011; Accepted 25 November 2011. Available online 9 December 2011.
Abstract
Background
Influenza vaccination is recommended for immunocompromised patients.
Methods
Children (6 months to 21 years) with cancer, HIV infection, or sickle cell disease (SCD) received 1 or 2 doses of pandemic 2009 H1N1 monovalent influenza vaccine (H1N1 MIV). Safety and tolerability, hemagglutination inhibition (HI) and microneutralization (MN) antibody titers were measured against 2009 H1N1 influenza A virus after each dose. Seroprotection (SP) and seroconversion (SC) rates were determined.
Results
103 participants were enrolled and 99 were evaluable (39 with HIV, 37 with cancer and 23 with SCD). Mean age (?SD) was 7.9 (?5.4) years for cancer participants, 18.0 (?3.5) for HIV, and 13.3 (?4.2) for SCD. 54% were males; 65% black; and 96% had received seasonal influenza vaccine. HIV-infected participants had a median CD4 count of 625 cells/mm3 (range, 140?1260). 46% had an undetectable HIV viral load and 41% were perinatally infected. No participant had vaccine-related serious adverse events. None developed influenza A proven illness during the 6 months after the vaccine. Local injection reactions were reported in 29% and systemic reactions in 42% after the first dose of vaccine. SC and SP were achieved after the last dose in 48% and 52%, respectively, of participants with leukemia or lymphoma, 50% and 75% of participants with solid tumors, 63% and 92% of HIV-infected participants, and 74% and 100% of participants with SCD.
Conclusion
H1N1 MIV was safe and well tolerated. H1N1 MIV resulted in an adequate immune response in children with SCD. It was only modestly immunogenic in cancer or HIV participants.
Highlights
► In 2009, an H1N1 monovalent influenza vaccine was recommended in addition to the seasonal vaccine. ► We evaluated the immunogenicity and safety of H1N1 influenza vaccine in immunocompromised children. ► The H1N1 vaccine was safe and well tolerated in children with cancer, HIV, and sickle cell disease. ► The H1N1 vaccine resulted in an adequate immune response in children with sickle cell disease. ► The H1N1 vaccine was only modestly immunogenic in children with cancer or HIV infection.
http://www.sciencedirect.com/science/article/pii/S0264410X11019013