Clinical trial NCT05076227: Effect of Different SARS-CoV-2 Vaccine Schedules and Vaccination Intervals on Reactogenicity and Humoral Immunogenicity
Official title: Comparison of Different BNT162b2 and ChAdOx1-S COVID-19 Vaccination Intervals and Combinations on Reactogenicity and Humoral Immunogenicity in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2 Infection
Immunisation Reaction
Antibody Hypersensitivity
Tolerance
Keywords: SARS-CoV2
COVID-19
mRNA vaccination
vector based vaccination
heterlogues vaccination
homologues vaccination
HelCoVac
Helios Hildesheim COVID-19 Vaccination Study
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 1206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital staff willing to be vaccinated against SARS-Cov-2 (COVID-19)

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.

Eligibility criteria: Inclusion Criteria:

* hospital staff who received COVID-19 vaccination

Exclusion Criteria:

* lack of a written informed consent

Primary outcomes:
measure: Difference between the four cohorts regarding the antibody of the viral spike protein 4 weeks after second vaccination
timeFrame: 4 weeks after second vaccination
measure: Difference between the four cohorts regarding the antibody of the viral spike protein 3 months after second vaccination
timeFrame: 3 months after second vaccination
measure: Difference between the four cohorts regarding the antibody of the viral spike protein 6 months after second vaccination
timeFrame: 6 months after second vaccination
measure: Difference between the four cohorts regarding the antibody of the viral spike protein directly before boost vaccination
timeFrame: directly before boost vaccination
measure: Difference between the four cohorts regarding the antibody of the viral spike protein 4 weeks after boost vaccination
timeFrame: 4 weeks after boost vaccination
measure: Difference between the four cohorts regarding the antibody of the viral spike protein 3 months after boost vaccination
timeFrame: 3 months after boost vaccination
Secondary outcomes:
measure: Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the first vaccination?
timeFrame: immediately after first vaccination
measure: Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the second vaccination?
timeFrame: immediately after second vaccination
measure: Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the boost vaccination?
timeFrame: immediately after third (boost) vaccination
measure: 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?
timeFrame: immediately after first vaccination
measure: 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?
timeFrame: immediately after second vaccination
measure: 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?
timeFrame: immediately after boost vaccination
measure: Is there a difference between the four cohorts regarding the severity of vaccination reactions?
timeFrame: immediately after first vaccination
measure: Is there a difference between the four cohorts regarding the severity of vaccination reactions?
timeFrame: immediately after second vaccination
measure: Is there a difference between the four cohorts regarding the severity of vaccination reactions?
timeFrame: immediately after boost vaccination
measure: Do the four cohorts differ with respect to the temporal occurrence of vaccination reactions?
timeFrame: immediately after first vaccination
measure: Do the four cohorts differ with respect to the temporal occurrence of vaccination reactions?
timeFrame: immediately after second vaccination
measure: Is there a difference between the four cohorts regarding the use of medication due to vaccination reactions?
timeFrame: first and second vaccination
measure: Do the four cohorts differ with regard to the need for a certificate of incapacity for work due to vaccination reactions?
timeFrame: immediately after first vaccination
measure: Are there differences regarding the job groups and the vaccination week days?
timeFrame: immediately after first vaccination
measure: Do the four cohorts differ with regard to the need for a certificate of incapacity for work due to vaccination reactions?
timeFrame: immediately after second vaccination
measure: Are there differences regarding the job groups and the vaccination week days?
timeFrame: immediately after second vaccination
measure: Do the four cohorts differ with regard to the need for a certificate of incapacity for work due to vaccination reactions?
timeFrame: immediately after boost vaccination
measure: Are there differences regarding the job groups and the vaccination week days?
timeFrame: immediately after boost vaccination
measure: Are there differences within the cohorts regarding vaccination reactions in subjects with a known allergy?
timeFrame: immediately after first vaccination
measure: Are there differences within the total population regarding vaccination reactions in subjects with a known allergy?
timeFrame: immediately after first vaccination
measure: Are there differences within the cohorts regarding vaccination reactions in subjects with a known allergy?
timeFrame: immediately after second vaccination
measure: Are there differences within the total population regarding vaccination reactions in subjects with a known allergy?
timeFrame: immediately after second vaccination
measure: 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?
timeFrame: 4 weeks after second vaccination
measure: Do the variables listed above have an influence on the level of antibody?
timeFrame: 4 weeks after second vaccination
measure: 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?
timeFrame: 3 months after second vaccination
measure: Do the variables listed above have an influence on the level of antibody?
timeFrame: 3 months after second vaccination
measure: 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?
timeFrame: 6 months after second vaccination
measure: Do the variables listed above have an influence on the level of antibody?
timeFrame: 6 months after second vaccination
measure: 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?
timeFrame: directly before boost vaccination
measure: Do the variables listed above have an influence on the level of antibody?
timeFrame: directly before boost vaccination
measure: 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?
timeFrame: 4 weeks after boost vaccination
measure: Do the variables listed above have an influence on the level of antibody?
timeFrame: 4 weeks after boost vaccination
measure: 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?
timeFrame: 3 months after boost vaccination
measure: Do the variables listed above have an influence on the level of antibody?
timeFrame: 3 months after boost vaccination
measure: Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at three months from baseline within the four cohorts?
timeFrame: 3 months after second vaccination
measure: Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at six months from baseline within the four cohorts?
timeFrame: 6 months after second vaccination
measure: Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at three months from baseline between the four cohorts?
timeFrame: 3 months after second vaccination
measure: Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at six months from baseline between the four cohorts?
timeFrame: 6 months after second vaccination
measure: Are there any subjects within the study follow-up period who had proven SARS Cov2 infection? (Comparison between groups)
timeFrame: until end of study
measure: Is there a correlation within the overall population between the level of antibody and detected SARS Cov2 infection?
timeFrame: 3 months and 6 months after second vaccination, directly before boost vaccination and 4 weeks and 3 months after boost vaccination
Other outcomes:
Locations:
city: Hildesheim
country: Germany
facility: Helios Hospital Hildesheim
state: Niedersachsen
Study officials:
affiliation: University of Witten/Herdecke
name: Serge C Thal, MD
role: STUDY_CHAIR
affiliation: Helios Clinical Hildesheim
name: Michael Dedroogh, MD
role: PRINCIPAL_INVESTIGATOR
References: