一项在英格兰的孕妇中进行的四期、多中心、随机临床试验，比较两种含百日咳疫苗在孕妇中的效果，及其对婴儿的疫苗反应。
A phase IV, multi-centre, randomized clinical trial comparing two pertussis-containing vaccines in pregnant women in England and vaccine responses in their infants.
机构信息
Paediatric Infectious Diseases Research Group, St George's, University of London, London, UK.
St George's University Hospitals NHS Foundation Trust, London, UK.
出版信息
BMC Med. 2021 Jun 8;19(1):138. doi: 10.1186/s12916-021-02005-5.
BACKGROUND
Pertussis vaccines containing three or five pertussis antigens are recommended in pregnancy in many countries, but no studies have compared the effect on infants' antigen-specific immunoglobulin G (IgG) concentrations. The aim of this study was to compare anti-pertussis IgG responses following primary immunization in infants of mothers vaccinated with TdaP-IPV (low dose diphtheria toxoid, tetanus toxoid, acellular pertussis [five antigens] and inactivated polio) or TdaP-IPV in pregnancy (three pertussis antigens).
METHODS
This multi-centre phase IV randomized clinical trial was conducted in a tertiary referral centre and primary care sites in England. Women were randomized to receive TdaP-IPV (n = 77) or TdaP-IPV (n = 77) at 28-32 gestational weeks. A non-randomized control group of 44 women who had not received a pertussis-containing vaccine in pregnancy and their 47 infants were enrolled post-partum.
RESULTS
Following infant primary immunization, there was no difference in the geometric mean concentrations (GMCs) of anti-pertussis toxin, filamentous haemagglutinin or pertactin IgG between infants born to women vaccinated with TdaP-IPV (n = 67) or TdaP-IPV (n = 63). However, the GMC of anti-pertussis toxin IgG was lower in infants born to TdaP-IPV- and TdaP-IPV-vaccinated mothers compared to infants born to unvaccinated mothers (n = 45) (geometric mean ratio 0.71 [0.56-0.90] and 0.78 [0.61-0.98], respectively); by 13 months of age, this difference was no longer observed.
CONCLUSION
Blunting of anti-pertussis toxin IgG response following primary immunization occurs in infants born to women vaccinated with TdaP-IPV and TdaP-IPV, with no difference between maternal vaccines. The blunting effect had resolved by 13 months of age. These results may be helpful for countries considering which pertussis-containing vaccine to recommend for use in pregnancy.
TRIAL REGISTRATION
ClinicalTrials.gov , NCT02145624 , registered 23 May 2014.
背景
许多国家建议在妊娠期间接种含有三种或五种百日咳抗原的百白破疫苗，但尚无研究比较其对婴儿抗原特异性免疫球蛋白 G（IgG）浓度的影响。本研究旨在比较母亲在妊娠期间接种 TdaP-IPV（低剂量白喉类毒素、破伤风类毒素、无细胞百日咳[五种抗原]和灭活脊髓灰质炎）或 TdaP-IPV 后婴儿在初次免疫接种后的抗百日咳 IgG 应答。
方法
这是一项在英国三级转诊中心和初级保健场所进行的多中心 IV 期随机临床试验。将女性随机分为 TdaP-IPV（n=77）或 TdaP-IPV（n=77）组，在 28-32 孕周时接种疫苗。还招募了未在妊娠期间接种含百日咳疫苗的 44 名女性及其 47 名婴儿作为非随机对照组，在产后入组。
结果
婴儿初次免疫接种后，接种 TdaP-IPV（n=67）或 TdaP-IPV（n=63）的母亲所生婴儿的抗百日咳毒素、丝状血凝素或 pertactin IgG 的几何平均浓度（GMC）之间无差异。然而，与未接种疫苗的母亲所生婴儿（n=45）相比，TdaP-IPV 和 TdaP-IPV 疫苗接种母亲所生婴儿的抗百日咳毒素 IgG GMC 较低（几何均数比分别为 0.71[0.56-0.90]和 0.78[0.61-0.98]）；到 13 月龄时，这种差异不再存在。
结论
在 TdaP-IPV 和 TdaP-IPV 疫苗接种的母亲所生婴儿中，初次免疫接种后抗百日咳毒素 IgG 反应减弱，但母体疫苗之间无差异。到 13 月龄时，这种减弱效应已消失。这些结果可能有助于国家在考虑推荐使用哪种含百日咳疫苗用于妊娠时提供参考。
试验注册
ClinicalTrials.gov，NCT02145624，于 2014 年 5 月 23 日注册。
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