Vaccine and Treatment Evaluation Units (VTEU)-DMID 21-0004

疫苗和治疗评估单位 (VTEU)-DMID 21-0004

• 批准号: 10429608
• 负责人: HANA M EL SAHLY
• 金额: $ 30.81万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-15 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10429608
• 关键词: Antibodies; Breastfed infant; COVID-19; COVID-19 vaccine; Clinical; Decision Making; Evaluation; Human Milk; Immune response; Individual; Infant; Influenza; Kinetics; Lactation; Medicine; Mothers; Narrative Medicine; Policies; Postpartum Period; Pregnancy; Prospective cohort study; Recommendation; Research Design; Safety; Specimen; Vaccinated; Vaccines; Woman; antibody transfer; college; immunogenicity; influenza virus vaccine; pregnant

BAYLOR COLLEGE OF MEDICINE- ABSTRACT The purpose of this study is to evaluate the immunogenicity and safety of various licensed or EUA SARS-CoV-2 vaccines administered to pregnant or lactating women and describe the transplacental antibody transfer and kinetics of antibodies in infants. We will also evaluate the durability of the antibodies in mothers and infants and assess breast milk antibodies in lactating women. We will evaluate breast milk antibodies to assess potential for protection against COVID- 19 in breastfed infants, similar to influenza vaccine protection from influenza illness in infants of mothers vaccinated during pregnancy or postpartum. We anticipate including up to 5 vaccines as part of this non-interventional study. It is expected that the results of this study will inform policy recommendations and personal decision-making on the use of approved SARS-CoV-2 vaccines in pregnant and lactating individuals.

贝勒医学院-摘要 本研究的目的是评价各种许可或EUA的免疫原性和安全性 SARS-CoV-2疫苗接种给孕妇或哺乳期妇女，并描述 婴儿经胎盘抗体转移和抗体动力学。我们还将评估 抗体在母亲和婴儿中的持久性，并评估哺乳期的母乳抗体 妇女我们将评估母乳抗体，以评估预防COVID的潜力- 在母乳喂养的婴儿中，类似于流感疫苗保护婴儿免受流感疾病的影响。 母亲在怀孕期间或产后接种疫苗。我们预计将包括多达5种疫苗， 这是非干预性研究的一部分。预计这项研究的结果将为政策提供信息， 关于使用已批准的SARS-CoV-2疫苗的建议和个人决策 在怀孕和哺乳期个体中。