OBJECTIVE: This study evaluated the immunogenicity, safety, and tolerability of a MF59-adjuvanted H5N1 vaccine in a population 6 months through 17 years of age. METHODS:Healthy subjects 6 to <36 months, 3 to <9 months, and 9 to <18 years of age were assigned randomly to receive 2 doses of either a MF59-adjuvanted H5N1 vaccine (7.5 μg/dose) or a MF59-adjuvanted trivalent seasonal influenza control vaccine (15 μg/dose for each antigen). Immunogenicity against the A/Vietnam/1194/2004-likevaccine strain was measured before and 3 weeks after the 2-dose primary series, through hemagglutination inhibition (HI), single radial hemolysis (SRH), and microneutralization. Local and systemic reactions were recorded. RESULTS: A total of 335 subjects received the H5N1 vaccine, and 137 subjects received theseasonal vaccine. Rates of seroprotection (HI titer of ≥40) against the H5N1 vaccine antigen were 97% for children 6 to 36 months and 3 to 9 years of age and 89% for older children. All subjects seroconverted in the SRH assay. Microneutralization titers of ≥40 were achieved by 99% of subjects, and ≥98% of subjects, respectively. Local reactions, particularly injection site pain in older children, were common, generally mild to moderate in nature, and transient and resolved spontaneously. Up to 5% of participants. There were no vaccine-related serious adverse events in either group. CONCLUSIONS: In this pediatric population, MF59-adjuvanted H5N1 vaccine was highly immunogenic, had a good safety profile, reactogenicity comparable with that of an adjuvanted seasonal influenza control vaccine.
RCT Entities:
OBJECTIVE: This study evaluated the immunogenicity, safety, and tolerability of a MF59-adjuvanted H5N1 vaccine in a population 6 months through 17 years of age. METHODS: Healthy subjects 6 to <36 months, 3 to <9 months, and 9 to <18 years of age were assigned randomly to receive 2 doses of either a MF59-adjuvanted H5N1 vaccine (7.5 μg/dose) or a MF59-adjuvanted trivalent seasonal influenza control vaccine (15 μg/dose for each antigen). Immunogenicity against the A/Vietnam/1194/2004-like vaccine strain was measured before and 3 weeks after the 2-dose primary series, through hemagglutination inhibition (HI), single radial hemolysis (SRH), and microneutralization. Local and systemic reactions were recorded. RESULTS: A total of 335 subjects received the H5N1 vaccine, and 137 subjects received the seasonal vaccine. Rates of seroprotection (HI titer of ≥40) against the H5N1 vaccine antigen were 97% for children 6 to 36 months and 3 to 9 years of age and 89% for older children. All subjects seroconverted in the SRH assay. Microneutralization titers of ≥40 were achieved by 99% of subjects, and ≥98% of subjects, respectively. Local reactions, particularly injection site pain in older children, were common, generally mild to moderate in nature, and transient and resolved spontaneously. Up to 5% of participants. There were no vaccine-related serious adverse events in either group. CONCLUSIONS: In this pediatric population, MF59-adjuvanted H5N1 vaccine was highly immunogenic, had a good safety profile, reactogenicity comparable with that of an adjuvanted seasonal influenza control vaccine.
Authors: Maikel V W van der Velden; Alexander Geisberger; Thomas Dvorak; Daniel Portsmouth; Richard Fritz; Brian A Crowe; Wolfgang Herr; Eva Distler; Eva M Wagner; Markus Zeitlinger; Robert Sauermann; Christoph Stephan; Hartmut J Ehrlich; P Noel Barrett; Gerald Aichinger Journal: Clin Vaccine Immunol Date: 2014-04-16
Authors: Gerald Aichinger; Barbara Grohmann-Izay; Maikel V W van der Velden; Sandor Fritsch; Manuela Koska; Daniel Portsmouth; Mary Kate Hart; Wael El-Amin; Otfried Kistner; P Noel Barrett Journal: Clin Vaccine Immunol Date: 2014-10-29
Authors: Weiping Cao; William G Davis; Jin Hyang Kim; Juan A De La Cruz; Andrew Taylor; Grant R Hendrickson; Amrita Kumar; Priya Ranjan; L Andrew Lyon; Jacqueline M Katz; Shivaprakash Gangappa; Suryaprakash Sambhara Journal: Nanomedicine Date: 2016-04-23 Impact factor: 5.307
Authors: Jennifer L Nayak; Katherine A Richards; Hongmei Yang; John J Treanor; Andrea J Sant Journal: J Infect Dis Date: 2014-11-06 Impact factor: 5.226