Antibody Detection of Vaccine-Induced Secretory Effects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-19

Study Completion Date

2023-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Maternal COVID-19 Vaccines on Breast Milk

NCT04751734

COVID-19 Vaccines

COMPLETED

Impact of Maternal COVID-19 Disease on Breast Milk and Infant Health

NCT04768244

Covid19

COMPLETED

Gestational Immunity for Transfer

NCT04802278

Covid19 Breastfeeding Vaccine Exposure Via Breast Milk

UNKNOWN

COVID-19 and Lactating Mothers

NCT04558320

Coronavirus Infection

COMPLETED

Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1c

NCT05004740

COVID-19 Vaccine Breastmilk

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

As the global and pandemic spread of the novel coronavirus (SARS-CoV-2, COVID-19) continues, many knowledge gaps remain regarding the epidemiology and transmission of infection, the immunological responses after viral exposure, and the immunological protection after vaccine administration. Cincinnati had its first confirmed case of COVID-19 on March 14, 2020, and despite extensive shelter-in-place and social distancing efforts, community spread has continued over the past 10 months with several distinct infection surges. As SARS-CoV-2 vaccines are becoming available in early 2021, it is important to understand the immunological effects of these vaccines and to contrast them to the effects of natural infection. Of particular interest are the immunological effects of SARS-CoV-2 vaccines for lactating women, and whether breast milk will include secretory antibodies against the virus that potentially confer protection to the breastfeeding infant. The investigators have a unique but time-limited opportunity to track the humoral immunological responses of SARS-CoV-2 vaccination among lactating women. The investigators designed Antibody Detection of Vaccine-Induced Secretory Effects (ADVISE) to collect and analyze serial breast milk samples for secretory antibody responses, along with periodic blood testing of the mothers and their breastfeeding children. In ADVISE, the investigators will document the prevalence and cumulative incidence of secretory antibody responses to SARS-CoV-2 vaccines, and gain insights into the protective immunological effects of elective vaccine administration.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19 Humoral Acquired Immunodeficiency Coronavirus SARS-CoV Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lactating Mothers

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

SARS-CoV-2 vaccine

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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