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Antibody Detection of Vaccine-Induced Secretory Effects

NCT04895475 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2025-07-30

No results posted yet for this study

Summary

The purpose of this research study is to conduct a prospective longitudinal surveillance research study, enrolling approximately 60 lactating mothers who receive the SARS-CoV-2 vaccine, and then following their clinical and laboratory parameters for up to 12 months. The overall goal is to investigate the characteristics of antibody formation in lactating women receiving SARS-CoV-2 vaccination, documenting the antibody isotypes, titers, duration, and transfer into milk over time.

Conditions

  • Covid19
  • Humoral Acquired Immunodeficiency
  • Coronavirus
  • SARS-CoV Infection

Interventions

BEHAVIORAL

SARS-CoV-2 vaccine

Baseline demographics, baseline breast milk samples, and blood collection will be obtained at the initial visit. Serial collections of breastmilk and blood as well as weekly self-administered monthly surveys will occur

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Russell Ware · Children's Hospital Medical Center, Cincinnati

  • Julie Ware · Children's Hospital Medical Center, Cincinnati

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-19
Primary Completion
2022-05-10
Completion
2023-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04895475 on ClinicalTrials.gov