COVID-19: study to detect transfer of SARS-Cov-2 antibodies in breastmilk
Phase 1
- Conditions
- pregnancylactating mothersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2021-000893-27-BE
- Lead Sponsor
- AZ Sint-Jan Brugge-Oostende AV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 15
Inclusion Criteria
- health care employees (or patients)
- 18 years or older
- voluntarily receiving vaccination
- pregnant or lactating
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- not eligible according to the inclusion criteria
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: lactating women who were vaccinated<br>blood sample<br>- before vaccination<br>- 4 weeks after first vaccin dose<br>- 8 weeks after second vaccin dose<br>breast milk<br>- 4 weeks after first vaccin dose<br>- 3 weeks after second vaccin dose<br>pregnant women who were COVID-infected<br>blood<br>- at time of delivery<br>milk<br>- 6 weeks postdelivery;Main Objective: to verify if Sars-Cov-2 specific antibodies can be demonstrated in blood<br>serum and milk of lactating mothers who were vaccinated;Secondary Objective: determination of COVID-antibodies in blood, milk and infant blood of<br>mothers vaccinated during lactation;Primary end point(s): presence and amount of IGM and IgG or IgA antibodies
- Secondary Outcome Measures
Name Time Method Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA