Antibody Detection of Vaccine-Induced Secretory Effects

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Coronavirus Infections Humoral Acquired Immunodeficiency Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV Infection Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

Any condition or illness that makes study participation ill-advised

Treatment and study plan

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

Primary outcomes

IgA antibodies against Spike protein

Time frame: 12 months

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

Secondary outcomes

SARS-CoV-2 antibodies

Time frame: 12 months

The associations between maternal serum antibodies (onset, titer, duration) and breast milk antibodies against SARS-CoV-2, as well as comparisons of antibody responses after vaccine to natural infection.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Acronym: ADVISE

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: May 20, 2021
Registry last updated: Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed