Antibody Detection of Vaccine-Induced Secretory Effects

NCT04895475 | Completed

• 1 other identifier: ADVISE
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• IgA antibodies against Spike protein

  A 3-month cumulative prevalence of IgA antibodies against Spike protein after the completed administration of the SARS-CoV-2 vaccine.

  12 months

Secondary Outcomes (1)

• SARS-CoV-2 antibodies

  12 months

Study Arms (1)

Lactating Mothers

Lactating mothers who plan to receive or have received the SARS-CoV-2 vaccine within 60 days.

Behavioral: SARS-CoV-2 vaccine

Interventions

SARS-CoV-2 vaccine BEHAVIORAL

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

Lactating Mothers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Lactating mothers receiving the SARS-CoV-2 (COVID-19) vaccine.

You may qualify if:

• Age ≥ 18.0 years at the time of enrollment
• Currently lactating mothers
• Planning to receive the SARS-CoV-2 vaccine in the next 60 days, or vaccinated with the SARS-CoV-2 vaccine within the past 60 days
• Cell phone that can be used for text messaging or web-based viewing of surveys
• Willing and able to provide informed consent
• Ability to comply with all study related evaluations and follow-up

You may not qualify if:

• Any condition or illness that makes study participation ill-advised

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Ware J, McElhinney K, Latham T, Lane A, Dienger-Stambaugh K, Hildeman D, Spearman P, Ware RE. Sustained and Boosted Antibody Responses in Breast Milk After Maternal SARS-CoV-2 Vaccination. Breastfeed Med. 2023 Aug;18(8):612-620. doi: 10.1089/bfm.2023.0106.

  PMID: 37615566 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Breast milk: A small amount of breast milk (up to 10 mL) will be collected by the mother and frozen for future analysis. One breast milk sample per week is requested during the first eight weeks of study participation or until 3 months after the final vaccine dose (whichever is longer). Samples can be provided at an increased frequency (up to five times per week) in special circumstances such as a recent COVID infection or childbirth, or off schedule at the time of weaning, at the request of the PI. Blood: Finger-stick blood samples will be collected from study participants at baseline and then every two weeks for four consecutive samples or until 3 months after the final vaccine dose (whichever is longer) for serologic testing. Blood will be collected monthly from 3 through 6 months after final vaccination, and quarterly thereafter. Volumes of blood will be up to 0.5 mL at each collection, using small-sample Mitra devices from a finger stick.

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Russell Ware

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Julie Ware

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: February 19, 2021
• Primary Completion: May 10, 2022
• Study Completion: August 31, 2023
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)