Antibody Detection of Vaccine-Induced Secretory Effects

Covid19 Clinical Trial

— ADVISE  

Official title:

Antibody Detection of Vaccine-Induced Secretory Effects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04895475
• Other study ID #: ADVISE
• Status: Active, not recruiting
• Start date: February 19, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Covid19
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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