COVID-19 VaccinesNCT04895007
Comparative Evaluation of Covid-19 Vaccines Response
An observational study of COVID-19 Vaccines, run by Karamanoğlu Mehmetbey University at 4 sites in Turkey (Türkiye).
Trial summary
Study Population Population with vaccinated with three different Covid Vaccines (Inactive Vaccine (Sinovac Life Sciences, Beijing, China), recombinant human adenovirus serotype number 26 (rAd26 of Sputnik V), mRNA Vaccine (Pfizer/BionTEC). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccines
- What is being tested?
- Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine
- Type of treatment
- Vaccines
- How many people
- 1,500 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Jun 2022
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: - Any person, male or female, over 18 years of age.
Who may be able to join
- Any person, male or female, over 18 years of age.
- The patient has signed an informed consent form.
- The patient was vaccinated with SARS-CoV-2 vaccine.
Who cannot join
- Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.)
- Person under safeguard of justice
- Person under guardianship or curator ship.
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Karamanoglu Mehmetbey University
Karaman, 70200
Taha T Bekci, Prof.Dr., +905333787676, doktortaha@gmail.com
- Recruiting
Selcuk University
Konya, 42250
Recep Kesli, Prof.Dr., +905454605460, recepkesli@gmail.com
- Not yet recruiting
Tekirdag Namık Kemal University, Faculty of Medicine
Tekirdağ
Nejat Altıntas, Assoc.Prof.Dr., nejataltintas@gmail.com
- Not yet recruiting
Karadeniz Technic University, Faculty of Medicine
Trabzon
Tevfik Ozlu, Prof.Dr., ozlutevfik@gmail.com
About this study
Official title: Comparative Evaluation of Covid-19 Vaccines Response and Progression in Different Covid-19 Vaccines Groups
Study Population
Population with vaccinated with three different Covid Vaccines (Inactive Vaccine (Sinovac Life Sciences, Beijing, China), recombinant human adenovirus serotype number 26 (rAd26 of Sputnik V), mRNA Vaccine (Pfizer/BionTEC). This is multi center study, 5 centers will be joined to study from different part of the country. Approximately 1500 people will be enrolled to study.
Read the detailed description
Aim of Study
- to evaluate Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody response in different Vaccine Groups
- to evaluate progression of the vaccine response after 2, 6, and 12 Months after Vaccination in different Vaccine Groups, and compare antibody response in different Vaccines Group.
- It was also aimed to evaluate effect of the age, gender, co-morbid conditions such as COPD, DM, Heart Failure, Covid Infection on IgG Antibody and Neutralizing Antibody response.
Anti SARS CoV2 IgG antibody levels will be measured with chemiluminescence method (CHEM) by using ADVIA Centaur XP Immunassay System (Siemens Helthcare, GmbH, Germany) and Anti SARS CoV2 IgG reactive (Siemens Helthineers, GmbH, Germany).
Neutralizing Capacity of Anti-SARS-CoV-2 Antibodies against SARS CoV2 levels will be determined with ELISA method (ELx 808, ELISA Microplate Absorbance Reader, BioTek Instruments Inc, Winooski, VT, USA) by using Euroimmun SARS-CoV-2 NeutraLISA Assay (EUROIMMUN, Medizinische Labordiagnostika AG, Germany).
- Conditions
- COVID-19 Vaccines
- Being tested
- Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccineBiological
Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody will be evaluated 2, 6, 12 Months after second dose.
| Study group | Role | What they receive |
|---|---|---|
| Group, vaccinated with Inactive Vaccine (Sinovac Life Sciences, Beijing, China). | - Any person, male or female, over 18 years of age, were vaccinated with Inactive Vaccine. Receives: Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine | |
| Group, vaccinated with recombinant human adenovirus serotype number 26 (rAd26 of Sputnik V). | - Any person, male or female, over 18 years of age, were vaccinated with recombinant human adenovirus serotype number 26. Receives: Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine | |
| Group, vaccinated with mRNA Vaccine (Pfizer/BionTEC). | - Any person, male or female, over 18 years of age, were vaccinated with mRNA Vaccine. Receives: Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody at 12 months
- Baseline Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody levels at 14th day after second dose
- Change of Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody levels at 3 Months after second dose
- Change of Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody levels at 6 Months after second dose
- Change of Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody levels at 12 Months after second dose
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 crossover
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.Dr.Taha Bekci, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895007
- Sponsor's protocol ID
- 2021-04-30T1
- Status last verified
- Jul 2021
- First submitted
- 14 May 2021
- Last updated
- 15 Jul 2021
- 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 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Covid-19 Vaccines Response and Progression in Different Covid-19 Vaccines Groups
- ClinicalTrials.gov ID
- NCT04895007
- Acronym / sponsor ID
- 2021-04-30T1
- Conditions
- COVID-19 Vaccines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 20 May 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.
Study Population
Population with vaccinated with three different Covid Vaccines (Inactive Vaccine (Sinovac Life Sciences, Beijing, China), recombinant human adenovirus serotype number 26 (rAd26 of Sputnik V), mRNA Vaccine (Pfizer/BionTEC). This is multi center study, 5 centers will be joined to study from different part of the country. Approximately 1500 people will be enrolled to study.
Detailed description
Aim of Study
- to evaluate Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody response in different Vaccine Groups
- to evaluate progression of the vaccine response after 2, 6, and 12 Months after Vaccination in different Vaccine Groups, and compare antibody response in different Vaccines Group.
- It was also aimed to evaluate effect of the age, gender, co-morbid conditions such as COPD, DM, Heart Failure, Covid Infection on IgG Antibody and Neutralizing Antibody response.
Anti SARS CoV2 IgG antibody levels will be measured with chemiluminescence method (CHEM) by using ADVIA Centaur XP Immunassay System (Siemens Helthcare, GmbH, Germany) and Anti SARS CoV2 IgG reactive (Siemens Helthineers, GmbH, Germany).
Neutralizing Capacity of Anti-SARS-CoV-2 Antibodies against SARS CoV2 levels will be determined with ELISA method (ELx 808, ELISA Microplate Absorbance Reader, BioTek Instruments Inc, Winooski, VT, USA) by using Euroimmun SARS-CoV-2 NeutraLISA Assay (EUROIMMUN, Medizinische Labordiagnostika AG, Germany).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group, vaccinated with Inactive Vaccine (Sinovac Life Sciences, Beijing, China). | – | Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine- Any person, male or female, over 18 years of age, were vaccinated with Inactive Vaccine. |
| Group, vaccinated with recombinant human adenovirus serotype number 26 (rAd26 of Sputnik V). | – | Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine- Any person, male or female, over 18 years of age, were vaccinated with recombinant human adenovirus serotype number 26. |
| Group, vaccinated with mRNA Vaccine (Pfizer/BionTEC). | – | Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine- Any person, male or female, over 18 years of age, were vaccinated with mRNA Vaccine. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - Any person, male or female, over 18 years of age.
Key inclusion criteria (3 listed)
- Any person, male or female, over 18 years of age.
- The patient has signed an informed consent form.
- The patient was vaccinated with SARS-CoV-2 vaccine.
Key exclusion criteria (3 listed)
- Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.)
- Person under safeguard of justice
- Person under guardianship or curator ship.
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 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccineAnti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody will be evaluated 2, 6, 12 Months after second dose. | Biological | Group, vaccinated with Inactive Vaccine (Sinovac Life Sciences, Beijing, China)., Group, vaccinated with mRNA Vaccine (Pfizer/BionTEC)., Group, vaccinated with recombinant human adenovirus serotype number 26 (rAd26 of Sputnik V). |
Primary outcome
Change from baseline in Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody at 12 months
Time frame: 12 Months
* Baseline Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody levels at 14th day after second dose * Change of Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody levels at 3 Months after second dose * Change of Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody levels at 6 Months after second dose * Change of Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody levels at 12 Months after second dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- 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.
Tekirdag Namık Kemal University, Faculty of Medicine
Tekirdağ, Turkey (Türkiye)
4 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 Karamanoğlu Mehmetbey University at 4 sites in Turkey (Türkiye).
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 3 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 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Turkey (Türkiye). 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody at 12 months (time frame: 12 Months). 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 15 Jul 2021.