Antibody Detection of Vaccine-Induced Secretory Effects (ADVISE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19; SARS-CoV Infection; Coronavirus; Humoral Acquired Immunodeficiency
• Intervention / Treatment: Behavioral: SARS-CoV-2 vaccine

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lactating Mothers; Lactating mothers who plan to receive or have received the SARS-CoV-2 vaccine within 60 days.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 antibodies	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.	12 months

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Russell Ware, Children's Hospital Medical Center, Cincinnati; Principal Investigator: Julie Ware, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Severe Acute Respiratory Syndrome
• Other Study ID Numbers: ADVISE (Company Internal)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No