Vaccine Research and Development.
J Infect Dis. 2014 Jan 1;209(1):12-23. doi: 10.1093/infdis/jit498. Epub 2013 Sep 16.
Children are highly vulnerable to infection with novel influenza viruses. It is essential to develop candidate pandemic influenza vaccines that are safe and effective in the pediatric population.
Infants and children aged 6-35 months and 3-8 years, respectively, were randomized to receive 2 immunizations with a 7.5-µg or 3.75-µg hemagglutinin (HA) dose of a nonadjuvanted whole-virus A/Vietnam(H5N1) vaccine; adolescents aged 9-17 years received a 7.5-µg dose only. A subset of participants received a booster immunization with an A/Indonesia(H5N1) vaccine approximately 1 year later. HA and neuraminidase antibody responses were assessed.
Vaccination was safe and well tolerated; adverse reactions were transient and predominantly mild. Two immunizations with the 7.5-µg dose of A/Vietnam vaccine induced virus microneutralization (MN) titers of ≥1:20 against the A/Vietnam strain in 68.8%-85.4% of participants in the different age groups. After the booster, 93.1%-100% of participants achieved MN titers of ≥1:20 against the A/Vietnam and A/Indonesia strains. Neuraminidase-inhibiting antibodies were induced in ≥90% of participants after 2 immunizations with the 7.5 µg A/Vietnam vaccine and in 100% of participants after the booster.
A whole-virus influenza A(H5N1) vaccine is suitable for prepandemic or pandemic immunization in a pediatric population.
NCT01052402.
儿童极易感染新型流感病毒。因此，开发安全、有效的儿童用大流行性流感候选疫苗至关重要。
分别将 6-35 月龄和 3-8 岁的婴儿和儿童随机分配接受 2 次免疫接种，每次接种剂量为 7.5-µg 或 3.75-µg 血凝素（HA）的无佐剂全病毒 A/Vietnam(H5N1)疫苗；9-17 岁的青少年仅接受 7.5-µg 剂量的免疫接种。大约 1 年后，部分参与者接受了 A/Indonesia(H5N1)疫苗的加强免疫接种。评估了 HA 和神经氨酸酶抗体反应。
接种疫苗安全且耐受良好；不良反应短暂且主要为轻度。2 次接种 7.5-µg 剂量的 A/Vietnam 疫苗后，不同年龄组的 68.8%-85.4%的参与者对 A/Vietnam 株的病毒微量中和（MN）滴度≥1:20。加强免疫后，93.1%-100%的参与者对 A/Vietnam 和 A/Indonesia 株的 MN 滴度均≥1:20。接种 7.5 µg A/Vietnam 疫苗 2 次后，≥90%的参与者产生了神经氨酸酶抑制抗体，100%的参与者在加强免疫后产生了神经氨酸酶抑制抗体。
全病毒流感 A(H5N1)疫苗适合儿童大流行前或大流行期间的免疫接种。
NCT01052402。
