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

Serge Thal

Status: Completed

Conditions: Antibody Hypersensitivity; SARS-CoV2 Infection; Tolerance; Immunisation Reaction

Treatments: Drug: IM injection of vaccination (mRNA vaccination); Drug: IM injection of vaccination (vector based vaccination)

Study type: Observational

Funder types: Other

Identifiers

NCT05076227

HelCoVac

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,206 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• hospital staff who received COVID-19 vaccination

Exclusion criteria

• lack of a written informed consent

Trial design

1,206 participants in 4 patient groups

BNT162b2/BNT162b2 - 3 wks

Description:

hospital staff receiving BioNTech as prime vaccination and also receiving BioNTech after 3 weeks as boost vaccination

Treatment:

Drug: IM injection of vaccination (mRNA vaccination)

ChAdOx1/ChAdOx1 - 12 wks

Description:

hospital staff receiving AstraZeneca as prime vaccination and also receiving AstraZeneca as boost vaccination after 12 weeks

Treatment:

Drug: IM injection of vaccination (vector based vaccination)

ChAdOx1/BNT162b2 - 12 wks

Description:

hospital staff receiving AstraZeneca as prime vaccination and receiving BioNTech as boost vaccination after 12 weeks

Treatment:

Drug: IM injection of vaccination (vector based vaccination)

Drug: IM injection of vaccination (mRNA vaccination)

BNT162b2/BNT162b2 - 6 wks

Description:

hospital staff receiving BioNTech as prime vaccination and also receiving BioNTech after 6 weeks as boost vaccination

Treatment:

Drug: IM injection of vaccination (mRNA vaccination)