COVID-19 Vaccine and Menstrual Health in Adolescents

项目总结/摘要 月经特征可以提供有关妇女整体健康和福祉的重要信息。然而， 最近的COVID-19疫苗临床试验未能收集到这一信息。这一点特别重要，因为 有报道称，COVID-19疫苗可能会影响月经模式， 特色此外，这种关系的潜在机制，如炎症， 反应或压力，尚未确定。这一行政补充的首要目标是， “COVID 19疫苗接种和月经”，是为了评估接种COVID-19疫苗和月经之间的关系， 19疫苗和月经健康（即，周期长度，出血持续时间，经期之间的点滴，月经 80名健康青春期女孩（年龄14-18岁，估计n=64， 将接受疫苗，n=16，将不接受疫苗并作为对照组）， 没有使用任何外源性激素的月经疼痛水平。这一目标将通过以下方式实现： 具体目标如下：1）表征COVID-19疫苗与炎症之间的关系， 在调整潜在混杂因素的影响（例如，雌二醇/孕酮水平和压力）; 2）确定 炎症标志物对月经健康指标的影响，在调整潜在的影响后， 混杂因素（例如，雌二醇/孕酮水平和压力）;以及3）确定COVID-19疫苗是否 与月经健康的变化通过炎症的变化相关，在调整潜在的影响后， 混杂因素（例如，雌二醇/孕酮水平和应激）。 作为母研究的一部分，参与者提供月经健康数据的基线水平， 每月一次，以表征月经健康（周期长度，月经疼痛，月经持续时间，流量， 期间之间的斑点）。参与这一补充将包括获得措施的压力和唾液 在10个不同时间点评估卵巢激素、促炎细胞因子和SARS-CoV-2抗体 时间点（疫苗接种前、疫苗接种后24小时、疫苗接种后48小时、疫苗接种后14天和疫苗接种后28天; 在Moderna或Pfizer-BioNTech疫苗第2次接种后重复接种，或如果发生以下情况，则在不接种第2次的情况下重复接种 接种约翰逊和约翰逊疫苗）。对照组将在相同的时间轴上提供数据。这些 预计结果将确定COVID-19疫苗与 月经健康存在，如果是这样，阐明这种关系背后可能的炎症机制。 该研究的结果将有助于描述COVID-19的潜在副作用，从而降低健康 育龄女孩和妇女之间的差距。

Project Summary/Abstract Menstrual characteristics can provide critical information about women’s overall health and well-being. Yet, recent clinical trials for the COVID-19 vaccine failed to gather this information. This is particularly relevant, as anecdotal reports have suggested that the COVID-19 vaccine may be affecting menstrual patterns and characteristics. Additionally, potential mechanisms underlying this relationship, such as inflammatory responses or stress, have not been identified. The overarching objective of this administrative supplement, “COVID19 Vaccination and Menstruation,” is to evaluate the relationship between administration of the COVID- 19 vaccine and menstrual health (i.e., cycle length, duration of bleeding, spotting between periods, menstrual flow, and menstrual pain) in a sample of 80 healthy adolescent girls (ages 14-18 years; estimated n=64 who will receive the vaccine, and n=16 who will not receive the vaccine and serve as the control group) with varying levels of menstrual pain who are not using any exogenous hormones. This objective will be achieved through the following specific aims: 1) characterize the relationship between the COVID-19 vaccine and inflammation, after adjusting for effects of potential confounders (e.g., levels of estradiol/progesterone and stress); 2) identify the impact of inflammatory markers on measures of menstrual health, after adjusting for effects of potential confounders (e.g., levels of estradiol/progesterone and stress); and 3) determine if the COVID-19 vaccine is associated with changes in menstrual health via changes in inflammation, after adjusting for effects of potential confounders (e.g., levels of estradiol/progesterone and stress). As part of the parent study, participants provide baseline levels of menstrual health data and are assessed monthly to characterize menstrual health (cycle length, menstrual pain, duration of menstruation, flow, and spotting between periods). Participation in this supplement will include obtaining measures of stress and saliva to assess for ovarian hormones, pro-inflammatory cytokines, and SARS-CoV-2 antibodies at 10 different time points (pre-vaccine, 24h post-vaccine, 48h post-vaccine, 14 days post-vaccine, and 28 days post-vaccine; repeated after 2nd dose of either Moderna or Pfizer-BioNTech vaccines, or repeated without a second dose if receiving the Johnson & Johnson vaccine). The control group will provide data on the identical timeline. These results are expected to determine whether a relationship between the COVID-19 vaccine and changes in menstrual health exist, and if so, elucidate possible inflammatory mechanisms underlying this relationship. Findings from the study will help characterize potential side effects of the COVID-19, thus reducing health disparities among reproductive-age girls and women.