Copenhagen Prospective Studies on Asthma in Childhood (COPSAC), Health Sciences, University of Copenhagen, Copenhagen University Hospital, Gentofte, Denmark.
PLoS One. 2013 Apr 18;8(4):e56700. doi: 10.1371/journal.pone.0056700. Print 2013.
Pregnant women were suspected to be at particular risk when H1N1pnd09 influenza became pandemic in 2009. Our primary objective was to compare the immune responses conferred by MF59®-adjuvanted vaccine (Focetria®) in H1N1pnd09-naïve pregnant and non-pregnant women. The secondary aims were to compare influences of dose and adjuvant on the immune response.
The study was nested in the Copenhagen Prospective Studies on Asthma in Childhood (COPSAC2010) pregnancy cohort in 2009-2010 and conducted as a single-blinded block-randomised [1∶1∶1] controlled clinical trial in pregnant women after gestational week 20: (1) 7.5 µg H1N1pnd09 antigen with MF59-adjuvant (Pa7.5 µg); (2) 3.75 µg antigen half MF59-adjuvanted (Pa3.75 µg); (3) 15 µg antigen unadjuvanted (P15 µg); and in non-pregnant women receiving (4) 7.5 µg antigen full adjuvanted (NPa7.5 µg). Blood samples were collected at baseline, 3 weeks, 3 and 10 months after vaccination, adverse events were recorded prospectively.
58 pregnant women were allocated to Pa7.5 µg and 149 non-pregnant women were recruited to NPa7.5 µg. The sero-conversion rate was significantly increased in non-pregnant (NPa7.5 µg) compared with pregnant (Pa7.5 µg) women (OR = 2.48 [1.03-5.95], p = 0.04) and geometric mean titers trended towards being higher, but this difference was not statistically significant (ratio 1.27 [0.85-1.93], p = 0.23). The significant titer increase rate showed no difference between pregnant (Pa7.5 µg) and non-pregnant (NPa7.5 µg) groups (OR = 0.49 [0.13-1.85], p = 0.29).
Our study suggests the immune response to the 7.5 µg MF59-adjuvanted Focetria® H1N1pnd09 vaccine in pregnant women may be diminished compared with non-pregnant women.
ClinicalTrials.gov NCT01012557.
2009 年 H1N1pnd09 流感大流行期间，孕妇被怀疑处于特别危险之中。我们的主要目的是比较 MF59®佐剂（Focetria®）疫苗在 H1N1pnd09 初免孕妇和非孕妇中的免疫反应。次要目的是比较剂量和佐剂对免疫反应的影响。
该研究嵌套在 2009-2010 年哥本哈根儿童哮喘前瞻性研究（COPSAC2010）妊娠队列中，并在妊娠 20 周后以单盲、区块随机化[1∶1∶1]对照临床试验的形式在孕妇中进行：（1）7.5µg H1N1pnd09 抗原与 MF59 佐剂（Pa7.5µg）；（2）半 MF59 佐剂的 3.75µg 抗原（Pa3.75µg）；（3）未佐剂的 15µg 抗原（P15µg）；非孕妇接受（4）7.5µg 抗原全佐剂（NPa7.5µg）。在接种后 3 周、3 个月和 10 个月采集血样，前瞻性记录不良事件。
58 名孕妇被分配到 Pa7.5µg，149 名非孕妇被招募到 NPa7.5µg。非孕妇（NPa7.5µg）的血清转化率明显高于孕妇（Pa7.5µg）（OR=2.48[1.03-5.95]，p=0.04），几何平均滴度也呈上升趋势，但差异无统计学意义（比值 1.27[0.85-1.93]，p=0.23）。孕妇（Pa7.5µg）和非孕妇（NPa7.5µg）组的显著滴度增加率无差异（OR=0.49[0.13-1.85]，p=0.29）。
我们的研究表明，与非孕妇相比，孕妇对 7.5µg MF59 佐剂 Focetria®H1N1pnd09 疫苗的免疫反应可能减弱。
ClinicalTrials.gov NCT01012557。
