Covid-19NCT06259656
Correlation of Antibody Response to COVID-19 Vaccination in Pregnant Woman and Transplacental Passage Into Cord Blood.
A study testing COVID-19 Spike Protein IgG Quantitative Antibody (CMIA) in people with Covid-19, run by Vachira Phuket Hospital at 1 site in Thailand.
Trial summary
The goal of this study is to study the correlation of maternal and cord blood level of Anti SAR-CoV. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Covid-19
- What is being tested?
- COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 25 Oct 2023to 25 Nov 2023
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Thai term pregnant women
- 18-45 year old
- At least 1 covid vaccination received
- admission at Vachira Phuket Hospital Labor Room
Who cannot join
- Do not want to participate
- Unstable or Emergency condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antibody Response to Coronavirus Disease 2019 (COVID-19) Vaccination in Pregnant Woman and Transplacental Passage Into Cord Blood.
The goal of this study is to study the correlation of maternal and cord blood level of Anti SAR-CoV.
Read the detailed description
The goal of this study is to study the correlation of maternal and cord blood level of Anti SAR-CoV. Sample size is 40 Thai patients at labor room Vachira Phuket Hospital in October - November 2023, who have at least one COVID-19 vaccination before or when pregnant. The Secondary outcome is to study time effect after COVID-19 vaccination and effect of vaccine type on Antibody level.
- Conditions
- Covid-19
- Being tested
- COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)
- Keywords
- Anti SARs-CoV, Pregnancy, Cordblood, Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)Diagnostic test
Maternal blood and cord blood were collected to test for COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)
| Study group | Role | What they receive |
|---|---|---|
| Thai term pregnant woman who have at least One dose of Covid vaccination | Other | Maternal and cord blood was collected to test COVID-19 Spike Protein IgG Quantitative Antibody (CMIA) Receives: Diagnostic Test: COVID-19 Spike Protein IgG Quantitative Antibody (CMIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Spike Protein IgG Quantitative Antibody (CMIA) Level
Test for correlation of level in maternal and cord blood
Measured: 1 month
Secondary outcomes (1)
Analysed time effect from last vaccination and type.
Test for time effect after last dose of vaccination
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start25 Oct 2023
- Primary completion25 Nov 2023
- Study completion25 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Thai term pregnant women are recruited at labor room, after informed consent was done. Characteristic data (such as vaccination type and time) and Maternal Blood was collected then cord blood was collected after birth. All blood was sent to test Anti SARs CoV antibody level. Then all data and 80 test result will analyzed.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vachira Phuket Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259656
- Sponsor's protocol ID
- VPH REC 009/2023
- Status last verified
- Oct 2023
- First submitted
- 13 Feb 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibody Response to Coronavirus Disease 2019 (COVID-19) Vaccination in Pregnant Woman and Transplacental Passage Into Cord Blood.
- ClinicalTrials.gov ID
- NCT06259656
- Acronym / sponsor ID
- VPH REC 009/2023
- Conditions
- Covid-19
- Keywords
- Anti SARs-CoV, Pregnancy, Cordblood, Vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vachira Phuket HospitalUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 25 Nov 2023 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 14 Feb 2024 (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.
The goal of this study is to study the correlation of maternal and cord blood level of Anti SAR-CoV.
Detailed description
The goal of this study is to study the correlation of maternal and cord blood level of Anti SAR-CoV. Sample size is 40 Thai patients at labor room Vachira Phuket Hospital in October - November 2023, who have at least one COVID-19 vaccination before or when pregnant. The Secondary outcome is to study time effect after COVID-19 vaccination and effect of vaccine type on Antibody level.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Thai term pregnant women are recruited at labor room, after informed consent was done. Characteristic data (such as vaccination type and time) and Maternal Blood was collected then cord blood was collected after birth. All blood was sent to test Anti SARs CoV antibody level. Then all data and 80 test result will analyzed.
| Arm | Type | Receives |
|---|---|---|
| Thai term pregnant woman who have at least One dose of Covid vaccination | Other | Diagnostic Test: COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)Maternal and cord blood was collected to test COVID-19 Spike Protein IgG Quantitative Antibody (CMIA) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Thai term pregnant women
- 18-45 year old
- At least 1 covid vaccination received
- admission at Vachira Phuket Hospital Labor Room
Key exclusion criteria (2 listed)
- Do not want to participate
- Unstable or Emergency condition
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-19 Spike Protein IgG Quantitative Antibody (CMIA)Maternal blood and cord blood were collected to test for COVID-19 Spike Protein IgG Quantitative Antibody (CMIA) | Diagnostic test | Thai term pregnant woman who have at least One dose of Covid vaccination |
Primary outcome
COVID-19 Spike Protein IgG Quantitative Antibody (CMIA) Level
Time frame: 1 month
Test for correlation of level in maternal and cord blood
1 secondary outcome
Analysed time effect from last vaccination and type.
Time frame: 1 month
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 3 Jul 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 Spike Protein IgG Quantitative Antibody (CMIA) in people with Covid-19, run by Vachira Phuket Hospital at 1 site in Thailand.
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 4 inclusion and 2 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
COVID-19 Spike Protein IgG Quantitative Antibody (CMIA) Level (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2024.