TY - JOUR
T1 - Safety and immunogenicity of influenza A H5 subunit vaccines
T2 - Effect of vaccine schedule and antigenic variant
AU - Belshe, Robert B.
AU - Frey, Sharon E.
AU - Graham, Irene
AU - Mulligan, Mark J.
AU - Edupuganti, Srilatha
AU - Jackson, Lisa A.
AU - Wald, Anna
AU - Poland, Gregory
AU - Jacobson, Robert
AU - Keyserling, Harry L.
AU - Spearman, Paul
AU - Hill, Heather
AU - Wolff, Mark
N1 - Funding Information:
National Institutes of Health contract numbers HHSN-272200800003C (to R.B.B), HHSN272200800005C (to M.J.M.), and HHSN272200800004C (to L.A.J.)
PY - 2011/3/1
Y1 - 2011/3/1
N2 - Background. The current US national stockpile of influenza H5 vaccine was produced using the antigen from the strain A/Vietnam/1203/2004 (a clade 1 H5 virus). Recent H5 disease has been caused by antigenically divergent H5 viruses, including A/Indonesia/05/2005 (a clade 2 H5 virus). Methods. The influence of schedule on the antibody response to 2 doses of H5 vaccines (one a clade 1 hemagglutinin protein [HA] vaccine and one a clade 2 HA vaccine) containing 90 lg of antigen was evaluated in healthy adults 18-49 years of age. Results. Two doses of vaccine were required to induce antibody titers ≥1:10 in most subjects. Accelerated schedules were immunogenic, and antibody developed after vaccinations on days 0 and 7, 0 and 14, and 0 and 28, with the day 0 and 7 schedule inducing lower titers than those induced with the other schedules. With mixed vaccine schedules of clade 1 followed by clade 2 vaccine administration, the first vaccination primed for a heterologous boost. The heterologous response was improved when the second vaccination was given 6 months after the first, compared with the response when the second vaccination was given after an interval of 1 month. Conclusions. An accelerated vaccine schedule of injections administered at days 0 and 14 was as immunogenic as a vaccine schedule of injections at days 0 and 28, but both schedules were inferior to a vaccine schedule of injections administered at 0 and 6 months for priming for heterologous vaccine boosting. Clinical Trial Registry Number: NCT00703053.
AB - Background. The current US national stockpile of influenza H5 vaccine was produced using the antigen from the strain A/Vietnam/1203/2004 (a clade 1 H5 virus). Recent H5 disease has been caused by antigenically divergent H5 viruses, including A/Indonesia/05/2005 (a clade 2 H5 virus). Methods. The influence of schedule on the antibody response to 2 doses of H5 vaccines (one a clade 1 hemagglutinin protein [HA] vaccine and one a clade 2 HA vaccine) containing 90 lg of antigen was evaluated in healthy adults 18-49 years of age. Results. Two doses of vaccine were required to induce antibody titers ≥1:10 in most subjects. Accelerated schedules were immunogenic, and antibody developed after vaccinations on days 0 and 7, 0 and 14, and 0 and 28, with the day 0 and 7 schedule inducing lower titers than those induced with the other schedules. With mixed vaccine schedules of clade 1 followed by clade 2 vaccine administration, the first vaccination primed for a heterologous boost. The heterologous response was improved when the second vaccination was given 6 months after the first, compared with the response when the second vaccination was given after an interval of 1 month. Conclusions. An accelerated vaccine schedule of injections administered at days 0 and 14 was as immunogenic as a vaccine schedule of injections at days 0 and 28, but both schedules were inferior to a vaccine schedule of injections administered at 0 and 6 months for priming for heterologous vaccine boosting. Clinical Trial Registry Number: NCT00703053.
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U2 - 10.1093/infdis/jiq093
DO - 10.1093/infdis/jiq093
M3 - Article
C2 - 21282194
AN - SCOPUS:79751471067
SN - 0022-1899
VL - 203
SP - 666
EP - 673
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 5
ER -