Vaccine ReactionDER-CoV2-001NCT04979871
SARS-CoV-2 Antibodies and Virus Neutralisation in a Cohort Vaccinted Against COVID-19
An observational study of Vaccine Reaction, run by University of Zurich at 1 site in Switzerland.
Trial summary
Analysis of SARS-CoV-2 antibodies and serum virus neutralisation in vaccinated heath care personnel. Analysis of virus neutralisation as a function of age, gender, and history of COVID-19 infection. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction
- What is being tested?
- Venous bleeding
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Jul 2021to 31 Dec 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Approximately 250 blood samples from 50 vaccinated persons working in the USZ Department of Dermatology were collected in 2020 and 2021. All individuals recieveid either one or two doses of BNT162b2 (BioNTech/Pfizer) vaccine between January 2021 and June 2021. The persons providing blood samples (study subjects) were recruited by a general email (in English) to all members of the research unit of the Department of Dermatology (cf. Appendix). The sera were frozen and kept at the Dermatology biobank. The samples are labelled with subjects initials and date of sampling.
Who may be able to join
- Employed at the USZ Department of Dermatology
- Vaccinated against Covid-19 at USZ
- Male and female persons of any age
- Serum samples collected in 2020 or until June 11th 2021
- The subject was informed and gave his/her consent to the research project (non-coded samples and data) and to publish data obtained from analysis of own biological samples
Who cannot join
- Known clinical relevant disease, e.g. immune suppressed by drugs or disease
- Documented objection of subsequent use and publication of biological samples and personal health data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinetics and Stability of Anti-SARS-CoV-2 Antibodies and Virus Neutralization After COVID-19 Vaccination in a Swiss Cohort
Analysis of SARS-CoV-2 antibodies and serum virus neutralisation in vaccinated heath care personnel. Analysis of virus neutralisation as a function of age, gender, and history of COVID-19 infection.
Read the detailed description
This study is an observational study with subsequent use of coded biological material. Sera of Universitiy Hospital of Zurich (USZ) personnel vaccinated with BNT162b2 (BioNTech/Pfizer) was analyzed for SARS-CoV-2 specific antibodies and virus neutralization.
Serum was analysed for virus-specific IgG and IgA using ELISA kits from Euroimmun (Kriens, Switzerland) according to the manufacturer's instruction. IgG was determined with the quantitative Anti-SARS-CoV-2 Quantivac kit and IgA was determined with the semi-quantitative Anti-SARS-CoV-2 kit The kits determine antibodies against the spike-1 protein. The sera were not diluted and not heat-inactivated prior to testing. The developed 96-well plates were analysed by reading absorbance at 450 nm using an ELx808 ELISA reader from BioTek Instr. Inc.
In addition, a SARS-CoV-2 neutralization assay was developed at the department. In this Tissue Culture Infection Dose (TCID) assay, Vero cells were infected with live SARS-CoV-2, and sera were added at various dilutions to test the potential to neutralize viral infection. The assay was conducted in a biosafety level 3 lab. Briefly, VERO-E6 cells were grown overnight to ca. 80-90% adherence in flat-bottom 96-well cell culture plates. The SARS-CoV-2 was then mixed in round-bottom 96 well titre plates with 2-fold serial dilutions of serum and incubated. The virus-serum mixture was then added to the VERO-E6 cell, and the cultures were incubated again. After three days, the cultures were fixed by addition of paraformaldehyde and stained with crystal violet for visualisation of cytotoxicity. The highest serum dilution preventing infections of the cells was defined as the neutralization titre.
- Conditions
- Vaccine Reaction
- Being tested
- Venous bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous bleedingProcedure or surgery
Blood samples collected 5 times with approx. 2-4 weeks interval
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunity to Covid-19 vaccines
Analysis SARS-CoV-2 immunity with ELISA anti-S1 IgG and IgA assay and tissue-culture infection dose (TCID) neutralisation assays
Measured: July 2021 through September 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start22 Jul 2021
- Primary completion30 Sep 2021
- Study completion31 Dec 2021
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 Vaccine ReactionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- 50 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pal Johansen, University of Zurich
- Investigators
- Pål Johansen, Prof, Principal investigator, University of Zurich, Dept. Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979871
- Sponsor's protocol ID
- DER-CoV2-001
- Other IDs
- BASEC Nr
- Acronym
- DER-CoV2-001
- Status last verified
- May 2023
- First submitted
- 25 Jul 2021
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol is shared
Publications
Sosic L, Paolucci M, Duda A, Hasler F, Walton SM, Kundig TM, Johansen P. Kinetics and persistence of anti-SARS-CoV-2 neutralisation and antibodies after BNT162b2 vaccination in a Swiss cohort. Immun Inflamm Dis. 2022 Mar;10(3):e583. doi: 10.1002/iid3.583. Epub 2021 Dec 29.
PubMed 34965032
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics and Stability of Anti-SARS-CoV-2 Antibodies and Virus Neutralization After COVID-19 Vaccination in a Swiss Cohort
- ClinicalTrials.gov ID
- NCT04979871
- Acronym / sponsor ID
- DER-CoV2-001 / DER-CoV2-001
- Conditions
- Vaccine Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Jul 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.
Analysis of SARS-CoV-2 antibodies and serum virus neutralisation in vaccinated heath care personnel. Analysis of virus neutralisation as a function of age, gender, and history of COVID-19 infection.
Detailed description
This study is an observational study with subsequent use of coded biological material. Sera of Universitiy Hospital of Zurich (USZ) personnel vaccinated with BNT162b2 (BioNTech/Pfizer) was analyzed for SARS-CoV-2 specific antibodies and virus neutralization.
Serum was analysed for virus-specific IgG and IgA using ELISA kits from Euroimmun (Kriens, Switzerland) according to the manufacturer's instruction. IgG was determined with the quantitative Anti-SARS-CoV-2 Quantivac kit and IgA was determined with the semi-quantitative Anti-SARS-CoV-2 kit The kits determine antibodies against the spike-1 protein. The sera were not diluted and not heat-inactivated prior to testing. The developed 96-well plates were analysed by reading absorbance at 450 nm using an ELx808 ELISA reader from BioTek Instr. Inc.
In addition, a SARS-CoV-2 neutralization assay was developed at the department. In this Tissue Culture Infection Dose (TCID) assay, Vero cells were infected with live SARS-CoV-2, and sera were added at various dilutions to test the potential to neutralize viral infection. The assay was conducted in a biosafety level 3 lab. Briefly, VERO-E6 cells were grown overnight to ca. 80-90% adherence in flat-bottom 96-well cell culture plates. The SARS-CoV-2 was then mixed in round-bottom 96 well titre plates with 2-fold serial dilutions of serum and incubated. The virus-serum mixture was then added to the VERO-E6 cell, and the cultures were incubated again. After three days, the cultures were fixed by addition of paraformaldehyde and stained with crystal violet for visualisation of cytotoxicity. The highest serum dilution preventing infections of the cells was defined as the neutralization titre.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 250 blood samples from 50 vaccinated persons working in the USZ Department of Dermatology were collected in 2020 and 2021. All individuals recieveid either one or two doses of BNT162b2 (BioNTech/Pfizer) vaccine between January 2021 and June 2021. The persons providing blood samples (study subjects) were recruited by a general email (in English) to all members of the research unit of the Department of Dermatology (cf. Appendix). The sera were frozen and kept at the Dermatology biobank. The samples are labelled with subjects initials and date of sampling.
Key inclusion criteria (5 listed)
- Employed at the USZ Department of Dermatology
- Vaccinated against Covid-19 at USZ
- Male and female persons of any age
- Serum samples collected in 2020 or until June 11th 2021
- The subject was informed and gave his/her consent to the research project (non-coded samples and data) and to publish data obtained from analysis of own biological samples
Key exclusion criteria (2 listed)
- Known clinical relevant disease, e.g. immune suppressed by drugs or disease
- Documented objection of subsequent use and publication of biological samples and personal health data
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 |
|---|---|---|
| Venous bleedingBlood samples collected 5 times with approx. 2-4 weeks interval | Procedure or surgery | – |
Primary outcome
Immunity to Covid-19 vaccines
Time frame: July 2021 through September 2021
Analysis SARS-CoV-2 immunity with ELISA anti-S1 IgG and IgA assay and tissue-culture infection dose (TCID) neutralisation assays
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 9 May 2023.
- Derived from this study: PubMed 34965032Sosic L, Paolucci M, Duda A, Hasler F, Walton SM, Kundig TM, Johansen P. Kinetics and persistence of anti-SARS-CoV-2 neutralisation and antibodies after BNT162b2 vaccination in a Swiss cohort. Immun Inflamm Dis. 2022 Mar;10(3):e583. doi: 10.1002/iid3.583. Epub 2021 Dec 29.
- Individual participant dataSharing planned: No. Study protocol is shared
Related trials for Vaccine Reaction
RecruitingEarly Phase 1
Intradermal Influenza Vaccination
Vaccine Reaction
Active, not recruitingPhase 4
Understanding Poor Vaccine Responses to Hepatitis B Vaccination
Vaccine Reaction
RecruitingPhase 1
Phase 1b Ascending Dose Study of PanChol in Healthy Volunteers
Cholera Vaccination Reaction
Not yet recruitingPhase 4
R21/MM Dosing, Presentations, and Preservatives
Plasmodium Falciparum Malaria, Malaria
RecruitingObservational study
Reduced Vaccine Response to HZ/su in SLE
Vaccine Reaction, Zoster
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.
Pål Johansen, Prof principal investigator
University of Zurich, Dept. Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Reaction, run by University of Zurich at 1 site in Switzerland.
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 5 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 9 May 2023. 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 Switzerland. 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?
Immunity to Covid-19 vaccines (time frame: July 2021 through September 2021). 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 NCT04979871, 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 9 May 2023.