在芬兰实施中性和仅限女孩接种 HPV 疫苗项目后孕妇 HPV 血清阳性率：一项基于群组随机试验的横断面队列分析。
Human papillomavirus seroprevalence in pregnant women following gender-neutral and girls-only vaccination programs in Finland: A cross-sectional cohort analysis following a cluster randomized trial.
机构信息
Faculty of Social Sciences, Tampere University, Tampere, Finland.
Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.
出版信息
PLoS Med. 2021 Jun 7;18(6):e1003588. doi: 10.1371/journal.pmed.1003588. eCollection 2021 Jun.
BACKGROUND
Cervical cancer elimination through human papillomavirus (HPV) vaccination programs requires the attainment of herd effect. Due to its uniquely high basic reproduction number, the vaccination coverage required to achieve herd effect against HPV type 16 exceeds what is attainable in most populations. We have compared how gender-neutral and girls-only vaccination strategies create herd effect against HPV16 under moderate vaccination coverage achieved in a population-based, community-randomized trial.
METHODS AND FINDINGS
In 2007-2010, the 1992-1995 birth cohorts of 33 Finnish communities were randomized to receive gender-neutral HPV vaccination (Arm A), girls-only HPV vaccination (Arm B), or no HPV vaccination (Arm C) (11 communities per trial arm). HPV16/18/31/33/35/45 seroprevalence differences between the pre-vaccination era (2005-2010) and post-vaccination era (2011-2016) were compared between all 8,022 unvaccinated women <23 years old and resident in the 33 communities during 2005-2016 (2,657, 2,691, and 2,674 in Arms A, B, and C, respectively). Post- versus pre-vaccination-era HPV seroprevalence ratios (PRs) were compared by arm. Possible outcome misclassification was quantified via probabilistic bias analysis. An HPV16 and HPV18 seroprevalence reduction was observed post-vaccination in the gender-neutral vaccination arm in the entire study population (PR16 = 0.64, 95% CI 0.10-0.85; PR18 = 0.72, 95% CI 0.22-0.96) and for HPV16 also in the herpes simplex virus type 2 seropositive core group (PR16 = 0.64, 95% CI 0.50-0.81). Observed reductions in HPV31/33/35/45 seroprevalence (PR31/33/35/45 = 0.88, 95% CI 0.81-0.97) were replicated in Arm C (PR31/33/35/45 = 0.79, 95% CI 0.69-0.90).
CONCLUSIONS
In this study we only observed herd effect against HPV16/18 after gender-neutral vaccination with moderate vaccination coverage. With only moderate vaccination coverage, a gender-neutral vaccination strategy can facilitate the control of even HPV16. Our findings may have limited transportability to other vaccination coverage levels.
TRIAL REGISTRATION
ClinicalTrials.gov number NCT00534638, https://clinicaltrials.gov/ct2/show/NCT00534638.
背景
通过人乳头瘤病毒（HPV）疫苗接种计划消除宫颈癌需要达到群体效应。由于其独特的高基本繁殖数，为了针对 HPV 型 16 达到群体效应，所需的疫苗接种覆盖率超过了大多数人群所能达到的水平。我们比较了在一项基于人群的社区随机试验中，适度接种覆盖率下，男女通用和仅限女孩接种策略如何针对 HPV16 产生群体效应。
方法和发现
2007-2010 年，33 个芬兰社区的 1992-1995 年出生队列被随机分配接受男女通用的 HPV 疫苗接种（Arm A）、仅限女孩的 HPV 疫苗接种（Arm B）或不接受 HPV 疫苗接种（Arm C）（每个试验臂有 11 个社区）。在 2005-2010 年的疫苗接种前时代和 2011-2016 年的疫苗接种后时代，比较了所有 8022 名未接种疫苗且年龄在 23 岁以下的居住在 2005-2016 年期间的 33 个社区的女性（分别为 Arm A、B 和 C 中的 2657、2691 和 2674 人）之间的 HPV16/18/31/33/35/45 血清阳性率差异。通过臂比较了疫苗接种后与疫苗接种前时代的 HPV 血清阳性率比值（PR）。通过概率偏差分析量化了可能的结果偏倚。在整个研究人群中（PR16=0.64，95%CI 0.10-0.85；PR18=0.72，95%CI 0.22-0.96），在男女通用的疫苗接种组中观察到 HPV16 和 HPV18 血清阳性率降低，在单纯疱疹病毒 2 血清阳性核心组中也观察到 HPV16 血清阳性率降低（PR16=0.64，95%CI 0.50-0.81）。在 Arm C 中，也复制了 HPV31/33/35/45 血清阳性率的降低（PR31/33/35/45=0.88，95%CI 0.81-0.97）（PR31/33/35/45=0.79，95%CI 0.69-0.90）。
结论
在这项研究中，我们仅在适度接种覆盖率下观察到针对 HPV16/18 的群体效应。在只有适度接种覆盖率的情况下，男女通用的疫苗接种策略可以促进 HPV16 的控制。我们的研究结果可能对其他接种覆盖率水平的推广有一定的局限性。
试验注册
ClinicalTrials.gov 编号 NCT00534638，https://clinicaltrials.gov/ct2/show/NCT00534638。
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