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Completed

NCT Number: NCT05076227

Effect of Different SARS-CoV-2 Vaccine Schedules and Vaccination Intervals on Reactogenicity and Humoral Immunogenicity

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

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Key information

Conditions

SARS-CoV2 Infection Antibody Hypersensitivity COVID-19 Coronaviridae Infections Coronavirus Infections Immunisation Reaction Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Tolerance Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helios Hospital Hildesheim

Hildesheim, Lower Saxony, 31135, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hospital staff who received COVID-19 vaccination

Exclusion criteria

  • lack of a written informed consent

Treatment and study plan

IM injection of vaccination (mRNA vaccination)

Drug

mRNA vaccination

Other names: Cormirnaty (BioNTech/Pfizer)

IM injection of vaccination (vector based vaccination)

Drug

vector based vaccination

Other names: AZD1222 (AstraZeneca)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. Is there a difference between the four cohorts regarding the severity of vaccination reactions?

    Time frame: 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.

  8. Is there a difference between the four cohorts regarding the severity of vaccination reactions?

    Time frame: 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.

  9. Is there a difference between the four cohorts regarding the severity of vaccination reactions?

    Time frame: 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.

  10. Do the four cohorts differ with respect to the temporal occurrence of vaccination reactions?

    Time frame: 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.

  11. Do the four cohorts differ with respect to the temporal occurrence of vaccination reactions?

    Time frame: 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.

  12. Is there a difference between the four cohorts regarding the use of medication due to vaccination reactions?

    Time frame: 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.

  13. 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

    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.

  14. Are there differences regarding the job groups and the vaccination week days?

    Time frame: 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.

  15. 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

    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.

  16. Are there differences regarding the job groups and the vaccination week days?

    Time frame: 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.

  17. 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

    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.

  18. Are there differences regarding the job groups and the vaccination week days?

    Time frame: 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.

  19. Are there differences within the cohorts regarding vaccination reactions in subjects with a known allergy?

    Time frame: 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.

  20. Are there differences within the total population regarding vaccination reactions in subjects with a known allergy?

    Time frame: 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.

  21. Are there differences within the cohorts regarding vaccination reactions in subjects with a known allergy?

    Time frame: 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.

  22. Are there differences within the total population regarding vaccination reactions in subjects with a known allergy?

    Time frame: 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.

  23. 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

    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.

  24. Do the variables listed above have an influence on the level of antibody?

    Time frame: 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.

  25. 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

    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.

  26. Do the variables listed above have an influence on the level of antibody?

    Time frame: 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. To investigate a potential influence of the variables, a logistic regression is performed if necessary.

  27. 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

    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.

  28. Do the variables listed above have an influence on the level of antibody?

    Time frame: 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. To investigate a potential influence of the variables, a logistic regression is performed if necessary.

  29. 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

    For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively.

  30. Do the variables listed above have an influence on the level of antibody?

    Time frame: 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.

  31. 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

    For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively.

  32. Do the variables listed above have an influence on the level of antibody?

    Time frame: 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.

  33. 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

    For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively.

  34. Do the variables listed above have an influence on the level of antibody?

    Time frame: 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.

  35. 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

    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.

  36. 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

    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.

  37. 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

    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.

  38. 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

    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.

  39. 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

    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.

  40. 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

    For the secondary endpoints, frequencies (%/n) for categorical data and corresponding measures of location (median, interquartile range) for continuous data are used descriptively.

Sponsors and collaborators

Lead sponsor

Serge Thal

Other

Registry information

Official study title

Comparison of Different BNT162b2 and ChAdOx1-S COVID-19 Vaccination Intervals and Combinations on Reactogenicity and Humoral Immunogenicity in Adults

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 13, 2021
Registry last updated
Dec 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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