COVID-19NCT05258708
COVID-19 Vaccine Reactogenicity and Immunogenicity
An observational study of COVID-19 and Vaccine Immune Response, run by Korea University Guro Hospital at 5 sites in South Korea.
Trial summary
Analysis of antibody kinetics after vaccination with mRNA-1273 and factors influencing the vaccine immunogenicity Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Vaccine Immune Response, Vaccine Adverse Reaction
- What is being tested?
- mRNA-1273 COVID-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 179 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 24 Jun 2021to 30 May 2022
- How long will I take part?
- 6 Months
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy young adults between the ages of 19 and 55 years who were willing to receive the mRNA-1273 vaccine were enrolled in the study and provided written informed consent
Who may be able to join
- who were willing to receive the mRNA-1273 vaccine
Who cannot join
- previously diagnosed with laboratory-confirmed COVID-19
- history of autoimmune disease
- immunocompromised, pregnant, or breastfeeding
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
Catholic Kwandong University
Incheon
Min Joo Choi, 821041156525
- Recruiting
Kangnam Sacred Heart Hospital
Seoul
Yu Bin Seo
- Recruiting
Korea University Anam Hospital
Seoul
Young Kyung Yoon
- Recruiting
Korea University Guro Hospital, International St. Mary's Hospital, Gangnam Sacred Heart Hospital, Ajou University School of Medicine, Korea University Anam Hospital
Seoul
Joon Young Song, infection@korea.ac.kr
Seung Hoe Song, 82226261635, ssesong@korea.ac.kr
- Recruiting
Ajou University School of Medicine Hallym University
Suwon
Jung Yeon Heo
About this study
Official title: Predictive Value of Reactogenicity for Anti-SARS-CoV-2 Antibody Response in mRNA-1273 Recipients: a Multicenter Prospective Cohort Study
Analysis of antibody kinetics after vaccination with mRNA-1273 and factors influencing the vaccine immunogenicity
Read the detailed description
We conducted a prospective study on healthy young adults who were to receive two doses of mRNA-1273 vaccine at 28-day intervals. After each dose, adverse events were prospectively evaluated, and blood samples were collected. The correlation between humoral immune response and reactogenicity after vaccination was determined. In addition, long-term anti-SARS-CoV-2 antibody kinetics will be assessed.
- Conditions
- COVID-19, Vaccine Immune Response, Vaccine Adverse Reaction
- Being tested
- mRNA-1273 COVID-19 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.
mRNA-1273 COVID-19 vaccineBiological
two doses of mRNA-1273 vaccine at 28-day intervals
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between humoral immune response and reactogenicity after vaccination
The correlation between humoral immune response and reactogenicity after vaccination
Measured: The correlation between reactogenicity after dose 1 and immunogenicity at T1 (28 days after dose 1 prior to the 2nd dose) and T2 (28 days after dose 2); the correlation between reactogenicity after vaccine dose 2 and immunogenicity at T2
Secondary outcomes (4)
anti-SARS-CoV-2 antibody
SARS-CoV-2 immunoglobulin G (IgG) assay (Abbott Laboratories, Chicago, IL, USA)
Measured: before vaccination (T0), 28 days after the first dose prior to the second dose (T1), and 28 days after the second dose (T2)
neutralizing antibody titer
plaque reduction neutralization test was performed using wild-type SARS-CoV-2 virus (BetaCoV/Korea/KCDC03/2020)
Measured: before vaccination (T0), 28 days after the first dose prior to the second dose (T1), and 28 days after the second dose (T2)
reactogenicity after vaccination
record the occurrence, severity, and duration of solicited AEs using a standardized electronic questionnaire
Measured: Seven days after each dose of vaccine
Long-term persistence of anti-SARS-CoV-2 antibody and neutralizing antibody titer
SARS-CoV-2 immunoglobulin G (IgG) assay (Abbott Laboratories, Chicago, IL, USA); plaque reduction neutralization test was performed using wild-type SARS-CoV-2 virus (BetaCoV/Korea/KCDC03/2020)
Measured: At 3 months and 6 months after dose 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start24 Jun 2021
- Primary completion30 May 2022 (estimated)
- Study completion30 May 2022 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 179 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic Kwandong University, Ajou University School of Medicine, Hallym University Kangnam Sacred Heart Hospital, Korea University Anam Hospital, Korean Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Joon Young Song, Korea University Guro Hospital
- Investigators
- Joon Young Song, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258708
- Sponsor's protocol ID
- 2021GR0274
- Status last verified
- Feb 2022
- First submitted
- 25 Feb 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will make a decision after discussion with the staff of other hospitals. We will share data on adverse events and immunogenicity.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Reactogenicity for Anti-SARS-CoV-2 Antibody Response in mRNA-1273 Recipients: a Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05258708
- Acronym / sponsor ID
- 2021GR0274
- Conditions
- COVID-19, Vaccine Immune Response, Vaccine Adverse Reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 179 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Catholic Kwandong University, Ajou University School of Medicine, Hallym University Kangnam Sacred Heart Hospital, Korea University Anam Hospital, Korean Center for Disease Control and Prevention
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 28 Feb 2022 (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.
Analysis of antibody kinetics after vaccination with mRNA-1273 and factors influencing the vaccine immunogenicity
Detailed description
We conducted a prospective study on healthy young adults who were to receive two doses of mRNA-1273 vaccine at 28-day intervals. After each dose, adverse events were prospectively evaluated, and blood samples were collected. The correlation between humoral immune response and reactogenicity after vaccination was determined. In addition, long-term anti-SARS-CoV-2 antibody kinetics will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy young adults between the ages of 19 and 55 years who were willing to receive the mRNA-1273 vaccine were enrolled in the study and provided written informed consent
Key inclusion criteria (1 listed)
- who were willing to receive the mRNA-1273 vaccine
Key exclusion criteria (3 listed)
- previously diagnosed with laboratory-confirmed COVID-19
- history of autoimmune disease
- immunocompromised, pregnant, or breastfeeding
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 |
|---|---|---|
| mRNA-1273 COVID-19 vaccinetwo doses of mRNA-1273 vaccine at 28-day intervals | Biological | – |
Primary outcome
The correlation between humoral immune response and reactogenicity after vaccination
Time frame: The correlation between reactogenicity after dose 1 and immunogenicity at T1 (28 days after dose 1 prior to the 2nd dose) and T2 (28 days after dose 2); the correlation between reactogenicity after vaccine dose 2 and immunogenicity at T2
The correlation between humoral immune response and reactogenicity after vaccination
4 secondary outcomes
anti-SARS-CoV-2 antibody
Time frame: before vaccination (T0), 28 days after the first dose prior to the second dose (T1), and 28 days after the second dose (T2)
neutralizing antibody titer
Time frame: before vaccination (T0), 28 days after the first dose prior to the second dose (T1), and 28 days after the second dose (T2)
reactogenicity after vaccination
Time frame: Seven days after each dose of vaccine
Long-term persistence of anti-SARS-CoV-2 antibody and neutralizing antibody titer
Time frame: At 3 months and 6 months after dose 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Individual participant dataSharing planned: Undecided. We will make a decision after discussion with the staff of other hospitals. We will share data on adverse events and immunogenicity.
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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.
Joon Young Song principal investigator
Korea University Guro Hospital
5 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 and Vaccine Immune Response, run by Korea University Guro Hospital at 5 sites in South Korea.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joon Young Song (+82226263052, infection@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between humoral immune response and reactogenicity after vaccination (time frame: The correlation between reactogenicity after dose 1 and immunogenicity at T1 (28 days after dose 1 prior to the 2nd dose) and T2 (28 days after dose 2); the correlation between reactogenicity after vaccine dose 2 and immunogenicity at T2). 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 28 Feb 2022.