Antibody Detection of Vaccine-Induced Secretory Effects
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
Summary
- Conditions
- Coronavirus
- COVID-19
- Humoral Acquired Immunodeficiency
- SARS-CoV Infection
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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. Cincinnat...
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.
Tracking Information
- NCT #
- NCT04895475
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Russell Ware Children's Hospital Medical Center, Cincinnati Principal Investigator: Julie Ware Children's Hospital Medical Center, Cincinnati