SARS-CoV2 InfectionNCT05076227
Effect of Different SARS-CoV-2 Vaccine Schedules and Vaccination Intervals on Reactogenicity and Humoral Immunogenicity
An observational study of SARS-CoV2 Infection and Immunisation Reaction, run by Serge Thal at 1 site in Germany.
Trial summary
Investigation of the reactogenicity and immunogenicity of homologous and heterologous vaccine combinations with regard to the formation of SARS-CoV-2 antispike antibodies in health care workers after basic immunization and boost vaccination Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection, Immunisation Reaction, Antibody Hypersensitivity
- What is being tested?
- IM injection of vaccination (mRNA vaccination) and IM injection of vaccination (vector based vaccination)
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 1,206 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jan 2021to 27 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospital staff willing to be vaccinated against SARS-Cov-2 (COVID-19)
Who may be able to join
- hospital staff who received COVID-19 vaccination
Who cannot join
- lack of a written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Different BNT162b2 and ChAdOx1-S COVID-19 Vaccination Intervals and Combinations on Reactogenicity and Humoral Immunogenicity in Adults
Investigation of the reactogenicity and immunogenicity of homologous and heterologous vaccine combinations with regard to the formation of SARS-CoV-2 antispike antibodies in health care workers after basic immunization and boost vaccination
Read the detailed description
The basic immunizations (first and second vaccination) were performed from January to June 2021 using the m-RNA vaccine BNT162b2 (BioNTech/Pfizer, B)9 and the vector-based vaccine ChAdOx1-S (AstraZeneca, A). BNT162b2 was used to boost vaccine all study population. The time interval between the basic immunisation and the boost vaccination varied.
Four vaccine-groups could be distinguished:
Group 1 received BNT162b2 with the second vaccination 3 weeks after the first vaccination.
Vaccinees of groups 2 and 3 received AZD1222/ChAdOx1-S as first vaccination and could choose after 12 weeks whether second vaccination with BNT162b2 or AZD1222/ChAdOx1-S should be carried out. This results in homologous (first: AZD1222/ChAdOx1-S, second: AZD1222/ChAdOx1-S) and heterologous (first: AZD1222/ChAdOx1-S, second: BNT162b2) vaccine combinations.
Group 4 received BNT162b2 with the second vaccination 6 weeks after first vaccination.
Blood samples were collected at six time points: four weeks, three and six months after completion of the basic immunization, immediately before boost vaccination, four weeks and three months after boost vaccination.
Reactogenicity after first, second, and boost vaccination was assessed using questionnaires to determine vaccine-induced adverse drug reactions (ADR) within seven days after the respective vaccinations.
In addition, demographic data (age, gender, occupational group, allergies) were collected, local and systemic vaccination reactions are differentiated and the need for medication and inability to work as a result of vaccination reactions are prospectively recorded.
- Being tested
- IM injection of vaccination (mRNA vaccination), IM injection of vaccination (vector based vaccination)
- Keywords
- SARS-CoV2, COVID-19, mRNA vaccination, vector based vaccination, heterlogues vaccination, homologues vaccination, HelCoVac, Helios Hildesheim COVID-19 Vaccination Study
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM injection of vaccination (mRNA vaccination)Drug
Also called Cormirnaty (BioNTech/Pfizer)
mRNA vaccination
IM injection of vaccination (vector based vaccination)Drug
Also called AZD1222 (AstraZeneca)
vector based vaccination
| Study group | Role | What they receive |
|---|---|---|
| BNT162b2/BNT162b2 - 3 wks | hospital staff receiving BioNTech as prime vaccination and also receiving BioNTech after 3 weeks as boost vaccination Receives: Drug: IM injection of vaccination (mRNA vaccination) | |
| ChAdOx1/ChAdOx1 - 12 wks | hospital staff receiving AstraZeneca as prime vaccination and also receiving AstraZeneca as boost vaccination after 12 weeks Receives: Drug: IM injection of vaccination (vector based vaccination) | |
| ChAdOx1/BNT162b2 - 12 wks | hospital staff receiving AstraZeneca as prime vaccination and receiving BioNTech as boost vaccination after 12 weeks Receives: Drug: IM injection of vaccination (mRNA vaccination); Drug: IM injection of vaccination (vector based vaccination) | |
| BNT162b2/BNT162b2 - 6 wks | hospital staff receiving BioNTech as prime vaccination and also receiving BioNTech after 6 weeks as boost vaccination Receives: Drug: IM injection of vaccination (mRNA vaccination) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the four cohorts regarding the antibody of the viral spike protein 4 weeks after second vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test.
The Bonferroni correction is applied accordingly.
Measured: 4 weeks after second vaccination
Difference between the four cohorts regarding the antibody of the viral spike protein 3 months after second vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test.
The Bonferroni correction is applied accordingly.
Measured: 3 months after second vaccination
Difference between the four cohorts regarding the antibody of the viral spike protein 6 months after second vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test.
The Bonferroni correction is applied accordingly.
Measured: 6 months after second vaccination
Difference between the four cohorts regarding the antibody of the viral spike protein directly before boost vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test.
The Bonferroni correction is applied accordingly.
Measured: directly before boost vaccination
Difference between the four cohorts regarding the antibody of the viral spike protein 4 weeks after boost vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test.
The Bonferroni correction is applied accordingly.
Measured: 4 weeks after boost vaccination
Difference between the four cohorts regarding the antibody of the viral spike protein 3 months after boost vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test.
The Bonferroni correction is applied accordingly.
Measured: 3 months after boost vaccination
Secondary outcomes (40)
Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the first vaccination?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after first vaccination
Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the second vaccination?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after second vaccination
Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the boost vaccination?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after third (boost) vaccination
Differences between the 4 groups after first vaccination regarding a. the individual local vaccination reactions? b. the individual systemic vaccination reactions? c. the number or percentage of vaccination reactions?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after first vaccination
Differences between the 4 groups after second vaccination regarding a. the individual local vaccination reactions? b. the individual systemic vaccination reactions? c. the number or percentage of vaccination reactions?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after second vaccination
Differences between the 4 groups after boost vaccination regarding a. the individual local vaccination reactions? b. the individual systemic vaccination reactions? c. the number or percentage of vaccination reactions?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after boost vaccination
Is there a difference between the four cohorts regarding the severity of vaccination reactions?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after first vaccination
Is there a difference between the four cohorts regarding the severity of vaccination reactions?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after second vaccination
Is there a difference between the four cohorts regarding the severity of vaccination reactions?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after boost vaccination
Do the four cohorts differ with respect to the temporal occurrence of vaccination reactions?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after first vaccination
Do the four cohorts differ with respect to the temporal occurrence of vaccination reactions?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after second vaccination
Is there a difference between the four cohorts regarding the use of medication due to vaccination reactions?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: first and second vaccination
Do the four cohorts differ with regard to the need for a certificate of incapacity for work due to vaccination reactions?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after first vaccination
Are there differences regarding the job groups and the vaccination week days?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after first vaccination
Do the four cohorts differ with regard to the need for a certificate of incapacity for work due to vaccination reactions?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after second vaccination
Are there differences regarding the job groups and the vaccination week days?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after second vaccination
Do the four cohorts differ with regard to the need for a certificate of incapacity for work due to vaccination reactions?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after boost vaccination
Are there differences regarding the job groups and the vaccination week days?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after boost vaccination
Are there differences within the cohorts regarding vaccination reactions in subjects with a known allergy?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after first vaccination
Are there differences within the total population regarding vaccination reactions in subjects with a known allergy?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after first vaccination
Are there differences within the cohorts regarding vaccination reactions in subjects with a known allergy?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after second vaccination
Are there differences within the total population regarding vaccination reactions in subjects with a known allergy?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: immediately after second vaccination
Is there a correlation within cohorts or within the overall population at four weeks regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. Spearman's correlation is calculated.
Measured: 4 weeks after second vaccination
Do the variables listed above have an influence on the level of antibody?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. To investigate a potential influence of the variables, a logistic regression is performed if necessary.
Measured: 4 weeks after second vaccination
Is there a correlation within cohorts or within the overall population at 3 months regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. Spearman's correlation is calculated.
Measured: 3 months after second vaccination
Do the variables listed above have an influence on the level of antibody?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. To investigate a potential influence of the variables, a logistic regression is performed if necessary.
Measured: 3 months after second vaccination
Is there a correlation within cohorts or within the overall population at 6 months regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. Spearman's correlation is calculated.
Measured: 6 months after second vaccination
Do the variables listed above have an influence on the level of antibody?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. To investigate a potential influence of the variables, a logistic regression is performed if necessary.
Measured: 6 months after second vaccination
Is there a correlation within cohorts or within the overall population directly before the boost regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively.
Measured: directly before boost vaccination
Do the variables listed above have an influence on the level of antibody?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively.
Measured: directly before boost vaccination
Is there a correlation within cohorts or within the overall population at 4 weeks after boost regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively.
Measured: 4 weeks after boost vaccination
Do the variables listed above have an influence on the level of antibody?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively.
Measured: 4 weeks after boost vaccination
Is there a correlation within cohorts or within the overall population at 3 months after boost regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively.
Measured: 3 months after boost vaccination
Do the variables listed above have an influence on the level of antibody?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively.
Measured: 3 months after boost vaccination
Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at three months from baseline within the four cohorts?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: 3 months after second vaccination
Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at six months from baseline within the four cohorts?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: 6 months after second vaccination
Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at three months from baseline between the four cohorts?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: 3 months after second vaccination
Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at six months from baseline between the four cohorts?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: 6 months after second vaccination
Are there any subjects within the study follow-up period who had proven SARS Cov2 infection? (Comparison between groups)
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively. The analysis is performed using appropriate tests such as Fisher's exact test, Chi² test, Mann-Whitney U test or Kruskal-Wallis test.
Measured: until end of study
Is there a correlation within the overall population between the level of antibody and detected SARS Cov2 infection?
For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively.
Measured: 3 months and 6 months after second vaccination, directly before boost vaccination and 4 weeks and 3 months after boost vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start30 Jan 2021
- Primary completion27 Mar 2022
- Study completion27 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies 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
- 1,206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serge Thal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Serge Thal, University of Witten/Herdecke
- Investigators
- Serge C Thal, MD, Study chair, University of Witten/HerdeckeMichael Dedroogh, MD, Principal investigator, Helios Clinical Hildesheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076227
- Sponsor's protocol ID
- HelCoVac
- Status last verified
- Dec 2022
- First submitted
- 23 Feb 2021
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different BNT162b2 and ChAdOx1-S COVID-19 Vaccination Intervals and Combinations on Reactogenicity and Humoral Immunogenicity in Adults
- ClinicalTrials.gov ID
- NCT05076227
- Acronym / sponsor ID
- HelCoVac
- Keywords
- SARS-CoV2, COVID-19, mRNA vaccination, vector based vaccination, heterlogues vaccination, homologues vaccination, HelCoVac, Helios Hildesheim COVID-19 Vaccination Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,206 participants (actual)
- Lead sponsor
- Serge ThalUniversity, hospital or other
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 27 Mar 2022 (actual)
- Study completion
- 27 Mar 2022 (actual)
- First posted
- 13 Oct 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.
Investigation of the reactogenicity and immunogenicity of homologous and heterologous vaccine combinations with regard to the formation of SARS-CoV-2 antispike antibodies in health care workers after basic immunization and boost vaccination
Detailed description
The basic immunizations (first and second vaccination) were performed from January to June 2021 using the m-RNA vaccine BNT162b2 (BioNTech/Pfizer, B)9 and the vector-based vaccine ChAdOx1-S (AstraZeneca, A). BNT162b2 was used to boost vaccine all study population. The time interval between the basic immunisation and the boost vaccination varied.
Four vaccine-groups could be distinguished:
Group 1 received BNT162b2 with the second vaccination 3 weeks after the first vaccination.
Vaccinees of groups 2 and 3 received AZD1222/ChAdOx1-S as first vaccination and could choose after 12 weeks whether second vaccination with BNT162b2 or AZD1222/ChAdOx1-S should be carried out. This results in homologous (first: AZD1222/ChAdOx1-S, second: AZD1222/ChAdOx1-S) and heterologous (first: AZD1222/ChAdOx1-S, second: BNT162b2) vaccine combinations.
Group 4 received BNT162b2 with the second vaccination 6 weeks after first vaccination.
Blood samples were collected at six time points: four weeks, three and six months after completion of the basic immunization, immediately before boost vaccination, four weeks and three months after boost vaccination.
Reactogenicity after first, second, and boost vaccination was assessed using questionnaires to determine vaccine-induced adverse drug reactions (ADR) within seven days after the respective vaccinations.
In addition, demographic data (age, gender, occupational group, allergies) were collected, local and systemic vaccination reactions are differentiated and the need for medication and inability to work as a result of vaccination reactions are prospectively recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BNT162b2/BNT162b2 - 3 wks | – | Drug: IM injection of vaccination (mRNA vaccination)hospital staff receiving BioNTech as prime vaccination and also receiving BioNTech after 3 weeks as boost vaccination |
| ChAdOx1/ChAdOx1 - 12 wks | – | Drug: IM injection of vaccination (vector based vaccination)hospital staff receiving AstraZeneca as prime vaccination and also receiving AstraZeneca as boost vaccination after 12 weeks |
| ChAdOx1/BNT162b2 - 12 wks | – | Drug: IM injection of vaccination (mRNA vaccination), Drug: IM injection of vaccination (vector based vaccination)hospital staff receiving AstraZeneca as prime vaccination and receiving BioNTech as boost vaccination after 12 weeks |
| BNT162b2/BNT162b2 - 6 wks | – | Drug: IM injection of vaccination (mRNA vaccination)hospital staff receiving BioNTech as prime vaccination and also receiving BioNTech after 6 weeks as boost vaccination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital staff willing to be vaccinated against SARS-Cov-2 (COVID-19)
Key inclusion criteria (1 listed)
- hospital staff who received COVID-19 vaccination
Key exclusion criteria (1 listed)
- lack of a written informed consent
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 |
|---|---|---|
| IM injection of vaccination (mRNA vaccination)Also: Cormirnaty (BioNTech/Pfizer)mRNA vaccination | Drug | BNT162b2/BNT162b2 - 3 wks, BNT162b2/BNT162b2 - 6 wks, ChAdOx1/BNT162b2 - 12 wks |
| IM injection of vaccination (vector based vaccination)Also: AZD1222 (AstraZeneca)vector based vaccination | Drug | ChAdOx1/BNT162b2 - 12 wks, ChAdOx1/ChAdOx1 - 12 wks |
Primary outcome
Difference between the four cohorts regarding the antibody of the viral spike protein 4 weeks after second vaccination
Time frame: 4 weeks after second vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.
Difference between the four cohorts regarding the antibody of the viral spike protein 3 months after second vaccination
Time frame: 3 months after second vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.
Difference between the four cohorts regarding the antibody of the viral spike protein 6 months after second vaccination
Time frame: 6 months after second vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.
Difference between the four cohorts regarding the antibody of the viral spike protein directly before boost vaccination
Time frame: directly before boost vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.
Difference between the four cohorts regarding the antibody of the viral spike protein 4 weeks after boost vaccination
Time frame: 4 weeks after boost vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.
Difference between the four cohorts regarding the antibody of the viral spike protein 3 months after boost vaccination
Time frame: 3 months after boost vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.
40 secondary outcomes
Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the first vaccination?
Time frame: immediately after first vaccination
Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the second vaccination?
Time frame: immediately after second vaccination
Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the boost vaccination?
Time frame: immediately after third (boost) vaccination
Differences between the 4 groups after first vaccination regarding a. the individual local vaccination reactions? b. the individual systemic vaccination reactions? c. the number or percentage of vaccination reactions?
Time frame: immediately after first vaccination
Differences between the 4 groups after second vaccination regarding a. the individual local vaccination reactions? b. the individual systemic vaccination reactions? c. the number or percentage of vaccination reactions?
Time frame: immediately after second vaccination
Differences between the 4 groups after boost vaccination regarding a. the individual local vaccination reactions? b. the individual systemic vaccination reactions? c. the number or percentage of vaccination reactions?
Time frame: immediately after boost vaccination
Is there a difference between the four cohorts regarding the severity of vaccination reactions?
Time frame: immediately after first vaccination
Is there a difference between the four cohorts regarding the severity of vaccination reactions?
Time frame: immediately after second vaccination
Is there a difference between the four cohorts regarding the severity of vaccination reactions?
Time frame: immediately after boost vaccination
Do the four cohorts differ with respect to the temporal occurrence of vaccination reactions?
Time frame: immediately after first vaccination
Do the four cohorts differ with respect to the temporal occurrence of vaccination reactions?
Time frame: immediately after second vaccination
Is there a difference between the four cohorts regarding the use of medication due to vaccination reactions?
Time frame: first and second vaccination
Do the four cohorts differ with regard to the need for a certificate of incapacity for work due to vaccination reactions?
Time frame: immediately after first vaccination
Are there differences regarding the job groups and the vaccination week days?
Time frame: immediately after first vaccination
Do the four cohorts differ with regard to the need for a certificate of incapacity for work due to vaccination reactions?
Time frame: immediately after second vaccination
Are there differences regarding the job groups and the vaccination week days?
Time frame: immediately after second vaccination
Do the four cohorts differ with regard to the need for a certificate of incapacity for work due to vaccination reactions?
Time frame: immediately after boost vaccination
Are there differences regarding the job groups and the vaccination week days?
Time frame: immediately after boost vaccination
Are there differences within the cohorts regarding vaccination reactions in subjects with a known allergy?
Time frame: immediately after first vaccination
Are there differences within the total population regarding vaccination reactions in subjects with a known allergy?
Time frame: immediately after first vaccination
Are there differences within the cohorts regarding vaccination reactions in subjects with a known allergy?
Time frame: immediately after second vaccination
Are there differences within the total population regarding vaccination reactions in subjects with a known allergy?
Time frame: immediately after second vaccination
Is there a correlation within cohorts or within the overall population at four weeks regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?
Time frame: 4 weeks after second vaccination
Do the variables listed above have an influence on the level of antibody?
Time frame: 4 weeks after second vaccination
Is there a correlation within cohorts or within the overall population at 3 months regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?
Time frame: 3 months after second vaccination
Do the variables listed above have an influence on the level of antibody?
Time frame: 3 months after second vaccination
Is there a correlation within cohorts or within the overall population at 6 months regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?
Time frame: 6 months after second vaccination
Do the variables listed above have an influence on the level of antibody?
Time frame: 6 months after second vaccination
Is there a correlation within cohorts or within the overall population directly before the boost regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?
Time frame: directly before boost vaccination
Do the variables listed above have an influence on the level of antibody?
Time frame: directly before boost vaccination
Is there a correlation within cohorts or within the overall population at 4 weeks after boost regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?
Time frame: 4 weeks after boost vaccination
Do the variables listed above have an influence on the level of antibody?
Time frame: 4 weeks after boost vaccination
Is there a correlation within cohorts or within the overall population at 3 months after boost regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?
Time frame: 3 months after boost vaccination
Do the variables listed above have an influence on the level of antibody?
Time frame: 3 months after boost vaccination
Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at three months from baseline within the four cohorts?
Time frame: 3 months after second vaccination
Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at six months from baseline within the four cohorts?
Time frame: 6 months after second vaccination
Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at three months from baseline between the four cohorts?
Time frame: 3 months after second vaccination
Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at six months from baseline between the four cohorts?
Time frame: 6 months after second vaccination
Are there any subjects within the study follow-up period who had proven SARS Cov2 infection? (Comparison between groups)
Time frame: until end of study
Is there a correlation within the overall population between the level of antibody and detected SARS Cov2 infection?
Time frame: 3 months and 6 months after second vaccination, directly before boost vaccination and 4 weeks and 3 months after boost vaccination
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 30 Dec 2022.
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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.
Serge C Thal, MD study chair
University of Witten/Herdecke
Michael Dedroogh, MD principal investigator
Helios Clinical Hildesheim
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 SARS-CoV2 Infection and Immunisation Reaction, run by Serge Thal at 1 site in Germany.
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 30 Dec 2022. 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 Germany. 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?
Difference between the four cohorts regarding the antibody of the viral spike protein 4 weeks after second vaccination (time frame: 4 weeks after second vaccination). The study lists 6 primary outcomes in all. 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 30 Dec 2022.