Antibody Hypersensitivity, Immunisation Reaction, SARS-CoV2 Infection, Tolerance
Conditions
Keywords
SARS-CoV2, COVID-19, mRNA vaccination, vector based vaccination, heterlogues vaccination, homologues vaccination, HelCoVac, Helios Hildesheim COVID-19 Vaccination Study
Brief 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
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.
Interventions
DRUGIM injection of vaccination (mRNA vaccination)
mRNA vaccination
DRUGIM injection of vaccination (vector based vaccination)
vector based vaccination
Sponsors
Serge Thal
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* hospital staff who received COVID-19 vaccination
Exclusion criteria
* lack of a written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between the four cohorts regarding the antibody of the viral spike protein 4 weeks after second vaccination | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Is there a difference between the four cohorts regarding the severity of vaccination reactions? | immediately after 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. |
| Do the four cohorts differ with respect to the temporal occurrence of vaccination reactions? | immediately after 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. |
| Is there a difference between the four cohorts regarding the use of medication due to vaccination reactions? | first and 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. |
| Do the four cohorts differ with regard to the need for a certificate of incapacity for work due to vaccination reactions? | immediately after 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. |
| Are there differences regarding the job groups and the vaccination week days? | immediately after 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. |
| Are there differences within the cohorts regarding vaccination reactions in subjects with a known allergy? | immediately after 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. |
| Are there differences within the total population regarding vaccination reactions in subjects with a known allergy? | immediately after 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. |
| 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? | 4 weeks after 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. Spearman's correlation is calculated. |
| Do the variables listed above have an influence on the level of antibody? | 4 weeks after 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. To investigate a potential influence of the variables, a logistic regression is performed if necessary. |
| 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? | 3 months after 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. Spearman's correlation is calculated. |
| Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the first vaccination? | immediately after 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. |
| 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? | directly before 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. |
| 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? | 4 weeks after 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. |
| 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? | 3 months after 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. |
| Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at three months from baseline within the four cohorts? | 3 months after 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. |
| Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at six months from baseline within the four cohorts? | 6 months after 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. |
| Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at three months from baseline between the four cohorts? | 3 months after 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. |
| Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at six months from baseline between the four cohorts? | 6 months after 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. |
| Are there any subjects within the study follow-up period who had proven SARS Cov2 infection? (Comparison between groups) | until end of study | 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. |
| Is there a correlation within the overall population between the level of antibody and detected SARS Cov2 infection? | 3 months and 6 months after second vaccination, directly before boost vaccination and 4 weeks and 3 months after 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. |
| 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? | 6 months after 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. Spearman's correlation is calculated. |
| Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the second vaccination? | immediately after 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. |
| Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the boost vaccination? | immediately after third (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. |
| 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? | immediately after 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. |
| 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? | immediately after 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. |
| 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? | immediately after 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. |
Countries
Germany
Outcome results
None listed