COVID-19 VaccinesMilkCoronaNCT04751734
Impact of Maternal COVID-19 Vaccines on Breast Milk
An observational study of COVID-19 Vaccines, run by Institute of Agrochemistry and Food Technology, National Research Council at 2 sites in Spain.
Trial summary
prospective multicenter study The main aim is to study the impact of maternal COVID-19 vaccination on breast milk immune, microbiological, and metabolic profile. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccines
- What is being tested?
- Covid vaccines
- Type of treatment
- Vaccines
- How many people
- 120 participants
- Where
- 2 sitesSpain
- Study dates
- 16 Jan 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women is Spain
Who may be able to join
- Priority groups for coronavirus (COVID-19) vaccination (health and social care workers) following breastfeeding practices and receiving vaccines.
Who cannot join
- cessation of breastfeeding and vaccine side-effects requiring specific treatment and/or hospitalization.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Fundacion Investigacion Sanitaria INCLIVA
Valencia
Hospital Universitario y Politecnico la Fe
Valencia
About this study
Official title: Impact of Maternal COVID-19 Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health
prospective multicenter study The main aim is to study the impact of maternal COVID-19 vaccination on breast milk immune, microbiological, and metabolic profile.
- Conditions
- COVID-19 Vaccines
- Being tested
- Covid vaccines
- Keywords
- breast milk, microbiota, metabolites, immune compounds, growth and development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid vaccinesBiological
women within Priority groups for coronavirus (COVID-19) vaccination
| Study group | Role | What they receive |
|---|---|---|
| Vaccinations | SARS-CoV-2 vaccination Receives: Biological: Covid vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibodies
presence and levels of antibodies
Measured: 1st year
Secondary outcomes (5)
breast milk bioactive composition
immune profile (cytokines and growth factors, immunoglobulins)
Measured: 1st year
breast milk bioactive composition
microbiota profile
Measured: 1st year
breast milk bioactive composition
metabolite profile
Measured: 1st year
infant microbiota
infant microbiota composition and diversity
Measured: 1st year
infant growth and development
z-scores growth curves
Measured: 1st year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start16 Jan 2021
- Primary completion31 Jan 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 VaccinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Agrochemistry and Food Technology, National Research Council
- Sponsor type
- Other government
- Collaborators
- Hospital Clínico Universitario de Valencia, Hospital Sant Joan de Deu, Hospital Universitario La Fe, Hospital Universitario Doctor Peset, Fundacion Para La Investigacion Hospital La Fe, Universitat Jaume I, University of Barcelona
- Responsible party
- Principal investigator, Maria Carmen Collado, Institute of Agrochemistry and Food Technology, National Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751734
- Sponsor's protocol ID
- IATA-CSIC
- Acronym
- MilkCorona
- Status last verified
- Mar 2024
- First submitted
- 8 Feb 2021
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Selma-Royo M, Bauerl C, Mena-Tudela D, Aguilar-Camprubi L, Perez-Cano FJ, Parra-Llorca A, Lerin C, Martinez-Costa C, Collado MC. Anti-SARS-CoV-2 IgA and IgG in human milk after vaccination is dependent on vaccine type and previous SARS-CoV-2 exposure: a longitudinal study. Genome Med. 2022 Apr 21;14(1):42. doi: 10.1186/s13073-022-01043-9.
PubMed 35449030
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Maternal COVID-19 Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health
- ClinicalTrials.gov ID
- NCT04751734
- Acronym / sponsor ID
- MilkCorona / IATA-CSIC
- Conditions
- COVID-19 Vaccines
- Keywords
- breast milk, microbiota, metabolites, immune compounds, growth and development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Institute of Agrochemistry and Food Technology, National Research CouncilOther government
- Collaborators
- Hospital Clínico Universitario de Valencia, Hospital Sant Joan de Deu, Hospital Universitario La Fe, Hospital Universitario Doctor Peset, Fundacion Para La Investigacion Hospital La Fe, Universitat Jaume I, University of Barcelona
- Study start
- 16 Jan 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
prospective multicenter study The main aim is to study the impact of maternal COVID-19 vaccination on breast milk immune, microbiological, and metabolic profile.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccinations | – | Biological: Covid vaccinesSARS-CoV-2 vaccination |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women is Spain
Key inclusion criteria (1 listed)
- Priority groups for coronavirus (COVID-19) vaccination (health and social care workers) following breastfeeding practices and receiving vaccines.
Key exclusion criteria (1 listed)
- cessation of breastfeeding and vaccine side-effects requiring specific treatment and/or hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covid vaccineswomen within Priority groups for coronavirus (COVID-19) vaccination | Biological | Vaccinations |
Primary outcome
Antibodies
Time frame: 1st year
presence and levels of antibodies
5 secondary outcomes
breast milk bioactive composition
Time frame: 1st year
breast milk bioactive composition
Time frame: 1st year
breast milk bioactive composition
Time frame: 1st year
infant microbiota
Time frame: 1st year
infant growth and development
Time frame: 1st year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Derived from this study: PubMed 35449030Selma-Royo M, Bauerl C, Mena-Tudela D, Aguilar-Camprubi L, Perez-Cano FJ, Parra-Llorca A, Lerin C, Martinez-Costa C, Collado MC. Anti-SARS-CoV-2 IgA and IgG in human milk after vaccination is dependent on vaccine type and previous SARS-CoV-2 exposure: a longitudinal study. Genome Med. 2022 Apr 21;14(1):42. doi: 10.1186/s13073-022-01043-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Vaccines, run by Institute of Agrochemistry and Food Technology, National Research Council at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibodies (time frame: 1st year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04751734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.