Department of Obstetrics and Gynecology, National Taiwan University Hospital, Hsin Chu branch, Hsin Chu, Taiwan.
PLoS One. 2013 Jun 6;8(6):e62983. doi: 10.1371/journal.pone.0062983. Print 2013.
There are little data about adverse effects and immunogenicity of flu vaccine in Asian pregnant women.
This prospective trial (NCT01514708) enrolled 46 pregnant women who received a single intramuscular dose of trivalent flu vaccine (AdimFlu-S®) containing 15 mcg of hemagglutinin for each strain/0.5 mL from influenza A (H1N1), influenza A (H3N2), and influenza B after the first trimester. Blood samples were collected at day 0 and 28 after vaccination, and at delivery. Cord blood was also collected. Hemagglutination inhibition (HAI) assays were performed to determine seroprotection and seroconversion rates and fold increase in the HAI geometric mean titer (GMT).
Twenty-eight days after vaccination the seroprotection rate against H1N1, H3N2, and influenza B was 91.3%, 84.8% and 56.5%, respectively. The GMT fold increase was 12.8, 8.4, and 4.6 for H1N1, H3N2, and influenza B, respectively. At delivery, both the seroprotection rate (86.4%, 68.2%, and 47.7%) and GMT fold increase (9.4, 5.7 and 3.8) were slightly lower than day 28. The seroprotection rate and GMT fold increase in maternal and cord blood samples were comparable. No significant adverse effects were detected.
Trivalent flu vaccine induces a strong immune response in pregnant women and their infants without adverse effects.
Clinical Trials. gov NCT01514708.
亚洲孕妇接种流感疫苗的不良反应和免疫原性数据较少。
本前瞻性试验（NCT01514708）纳入了 46 名孕妇，她们在妊娠中期后接受了含 15 mcg 血凝素的三价流感疫苗（AdimFlu-S®）单次肌肉注射，每 0.5 mL 含 1 株流感 A（H1N1）、流感 A（H3N2）和流感 B。于接种后第 0 天和第 28 天以及分娩时采集血样。还采集了脐血。通过血凝抑制（HAI）试验测定血清保护率和血清转化率以及 HAI 几何平均滴度（GMT）的倍数增加。
接种后 28 天，对 H1N1、H3N2 和流感 B 的血清保护率分别为 91.3%、84.8%和 56.5%。GMT 倍数增加分别为 12.8、8.4 和 4.6。分娩时，血清保护率（86.4%、68.2%和 47.7%）和 GMT 倍数增加（9.4、5.7 和 3.8）均略低于第 28 天。母血和脐血样本的血清保护率和 GMT 倍数增加相当。未检测到明显的不良反应。
三价流感疫苗在孕妇及其婴儿中诱导了强烈的免疫反应，且无不良反应。
ClinicalTrials.gov NCT01514708。
