COVID-19 Vaccine and Menstrual Health in Adolescents

项目摘要/摘要 月经特征可以提供有关女性整体健康和幸福的关键信息。然而， 最近对新冠肺炎疫苗的临床试验未能收集到这些信息。这一点特别相关，因为 坊间报道表明，新冠肺炎疫苗可能正在影响月经模式和 特点。此外，这种关系背后的潜在机制，如炎症 反应或压力，尚未确定。这份行政副刊的首要目标是， “COVID19疫苗接种与月经”是为了评估接种COVID与月经之间的关系。 19疫苗和月经健康(即周期长度、出血持续时间、经期间隔期斑点、月经 流动和月经疼痛)对80名健康青春期女孩(年龄14-18岁；估计n= 将接种疫苗，n=16将不接种疫苗并作为对照组)，不同 没有使用任何外源性激素的人的月经疼痛程度。这一目标将通过以下方式实现 具体目标如下：1)描述新冠肺炎疫苗和炎症之间的关系， 在调整了潜在混杂因素(例如，雌二醇/孕酮水平和压力)的影响后；2)确定 在调整潜在影响后，炎症标志物对月经健康指标的影响 混杂因素(例如，雌二醇/孕酮水平和压力)；3)确定新冠肺炎疫苗是否 在对潜在影响进行调整后，通过炎症变化与月经健康的变化相关 混杂因素(如雌二醇/孕酮水平和压力)。 作为家长研究的一部分，参与者提供月经健康数据的基线水平，并进行评估 每月描述月经健康状况(周期长度、月经疼痛、月经持续时间、月经流量和月经周期) 在两个时段之间进行点选)。参与这项补充将包括获得压力和唾液的测量。 在10个不同的时间评估卵巢激素、促炎细胞因子和SARS-CoV-2抗体 积分(疫苗前、疫苗后24小时、疫苗后48小时、疫苗后14天、疫苗后28天； 在接种第二剂莫德纳或辉瑞生物科技疫苗后重复接种，或在以下情况下不重复接种第二剂疫苗 接种强生疫苗)。控制组将在相同的时间线上提供数据。这些 预计结果将确定新冠肺炎疫苗与艾滋病变化之间的关系 月经健康是存在的，如果是这样的话，阐明这种关系潜在的可能的炎症机制。 这项研究的发现将有助于表征新冠肺炎的潜在副作用，从而降低健康 育龄女童和育龄妇女之间的差距。

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.