Multisite Observational Maternal and Infant Study for COVID-19 (NCT05031468) | Clinical Trial Compass
CompletedNot Applicable
Multisite Observational Maternal and Infant Study for COVID-19
United States562 participantsStarted 2021-07-06
Plain-language summary
This is an observational, non-interventional, prospective cohort study designed to collect clinical information and specimens to evaluate the immune responses from pregnant individuals and postpartum individuals and their infants following maternal receipt of licensed or Emergency Use Authorization (EUA) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria for Pregnancy Group (Group 1):
* Pregnant individuals who are scheduled to receive or have received complete vaccination series of any licensed or EUA SARS-CoV-2 vaccine during pregnancy. (NOTE: no limitation health status, or gestational age at enrollment)
* Willing and able to provide consent for study participation for herself and for her infant prior to initiation of any study procedures.
Inclusion Criteria for Postpartum Group (Group 3):
* Individuals who are scheduled to receive or who have initiated vaccination series of any licensed or EUA SARS-CoV-2 vaccine within the first 2 months postpartum. (NOTE: no limitation on health status).
* Willing and able to provide consent for study participation for herself and for her infant prior to initiation of any study procedures (a separate consent form will be used for their infants).
Inclusion Criteria for Additional Dose(s) During Pregnancy Group (Group 5):
* Pregnant individuals who received one dose or both doses of their primary vaccine series prior to pregnancy and are scheduled to receive or have received additional dose(s) of any licensed or EUA SARS-CoV-2 vaccine during pregnancy OR pregnant individuals who received complete vaccination series during pregnancy and are scheduled to receive or have received additional dose(s) of any licensed or EUA SARS-CoV-2 vaccine during pregnancy. (NOTE: no limitation on health status or gestational age at enrollment). This applies to individuals who have com…
What they're measuring
1
Change in Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Among Individuals Vaccinated During Pregnancy
Timeframe: Baseline, 28 days post-vaccination, at delivery, postpartum months 2, 6, and 12
2
Change in GMT of Neutralizing (Neut) Antibodies in Serum Among Individuals Vaccinated During Pregnancy
Timeframe: Baseline, 28 days post-vaccination, at delivery, postpartum months 2, 6, and 12
3
GMT of Cord Blood IgG
Timeframe: At delivery
4
Ratio of Cord Blood IgG to Maternal Serum IgG
Timeframe: At delivery
5
Neut antibodies of cord blood
Timeframe: At delivery
6
Ratio of cord blood Neut antibodies to maternal serum Neut antibodies
Timeframe: At delivery
7
Change GMT of serum IgG in Infants Born to Individuals Vaccinated During Pregnancy
Timeframe: At delivery, 2 months of age, 6 months of age
8
Change GMT of Neut antibodies in Infants Born to Individuals Vaccinated During Pregnancy