Vaccine and Treatment Evaluation Units (VTEU)-DMID 21-0004
- Funded by National Institutes of Health (NIH)
- Total publications:0 publications
Grant number: 3UM1AI148575-02S8
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Key facts
Disease
COVID-19Start & end year
20212024Known Financial Commitments (USD)
$308,091Funder
National Institutes of Health (NIH)Principal Investigator
Hana M El SahlyResearch Location
United States of AmericaLead Research Institution
BAYLOR COLLEGE OF MEDICINEResearch Priority Alignment
N/A
Research Category
Vaccines research, development and implementation
Research Subcategory
Phase 2 clinical trial
Special Interest Tags
N/A
Study Type
Clinical
Clinical Trial Details
Not applicable
Broad Policy Alignment
Pending
Age Group
Adults (18 and older)
Vulnerable Population
Women
Occupations of Interest
Unspecified
Abstract
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.