SARS-CoV-2 immunogenicity MedDRA version: 23.0 Level: LLT Classification code 10084272 Term: SARS-CoV-2 infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Comirnaty
Pharmaceutical Form: Concentrate for suspension for injection
INN or Proposed INN: Tozinameran
Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)
Concentration u
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject is willing, understanding and able to provide written informed consent (exception: for cohort 8 (Elderly) subjects unable to give informed consent may be included, provided that legal representative gives written informed consent) - Written informed consent prior to initiation of any study procedures - Subject understands and agrees to comply with planned study procedures. - Male or female adult =18 years of age at time of enrolment. - Participant belongs to only one of the following categories: - Healthy health care worker at one of the participating trial centers (HCW) - Participant with history of kidney transplantation (NTx) - haemato-oncological participant and participant with B-cell neoplasia (B-NPL) - Participant with neuroimmunological diseases such as multiple sclerosis (MS) and neuromyelitis optica spectrum disorders (NMOSD) - Participant with rheumatic and autoimmune diseases under immunosuppression (RAID) - Participant with primary immunodeficiency (PID) - Participant with chronic kidney failure undergoing a chemo dialysis (HD) - Participant = 70 years-of age, with none of the medical conditions specified above (elderly) - One of the following vaccination scenarios apply: - Subject will be vaccinated with a COVID-19 vaccine for the first time - Subject already received the first COVID-19 vaccination no longer than 6 month prior to enrolment - Absence of any conditions that prohibit or impede supplemental blood-sampling or throat swab. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1375 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1675
Exclusion criteria
Exclusion criteria: An individual who meets any of the following criteria will be excluded from participation in this study: - Any contraindications for SARS-CoV-2 vaccination (according to SmPCs) - Refusal to participate. - Participants unwilling or unable to consent to saving and propagation of pseudonymized medical data for study reasons. - Persons who are legally detained in an official institution - Persons who might be dependent on the sponsor, the investigator or the trial site. This exclusion criterion does not apply for cohort 1 (HCWs), as it is necessary for this population to participate. In order to assure that no pressure to participate is put on them, the recruitment procedure of HCWs must follow the respective SOP of the sponsor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of immunogenicity of SARS-CoV-2 vaccines in healthy individuals compared to special risk populations;Secondary Objective: Determination of differences in humoral and cellular immunity after different vaccine regimen (vaccine schedule, vaccine type, combination of vaccines), particularly between homologous and heterologous prime-boost regimen;Primary end point(s): Immunogenicity of COVID-19 vaccination six (up to max. nine months) months after first vaccination as confirmed by the presence of anti-SARS-CoV-2-specific antibodies, i.e. positivity in serological assay system (S1-IgG ELISA above the predefined lower detection limit).;Timepoint(s) of evaluation of this end point: after end of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: - Immunogenicity of COVID-19 vaccination one and three months after first vaccination as confirmed by the presence of anti-SARS-CoV-2-specific antibodies, i.e. positivity in serological assay system (S1-IgG ELISA above the predefined lower detection limit). - Immunogenicity of COVID-19 vaccination one, three, six and nine months after first vaccination as confirmed by the presence of SARS-CoV-2 -specific CD4+ T cells. - Immunogenicity of COVID-19 vaccination one, three, six and nine months after first vaccination as confirmed by the presence neutralizing antibodies against SARS-CoV-2 wildtype - Immunogenicity of the COVID-19 vaccination one, three, six and nine months after first vaccination as confirmed by the presence of neutralizing antibodies against different PANGO lineages of SARS-CoV-2 (e.g., B.1.1.7, B1.351, P.1) - Proportion of participants with symptomatic SARS-CoV-2 infection in special risk populations and health care workers - Differences in humoral and cellular immunogenicity in special risk populations (HCW, NTx, B-NPL, MS, RAID, PID, HD, elderly) - Differences in humoral and cellular immunogenicity after different vaccine regimen (vaccine schedule, vaccine type, combination of vaccines), particularly between homologous and heterologous prime-boost regimen - Change in acceptance and adherence to the use of non-pharmacological measures (nPM) after vaccination against COVID-19 - Safety and tolerability of vaccines in healthcare workers and special risk groups - For RAID and MS/NMOSD cohorts: Effects of vaccination on underlying chronic disease measured by disease activity scores (RAID: BASDAI, Funktionsfragebogen Hannover, Gelenkmännchen, VAS; MS/NMOSD: EDSS, PHQ-9, GEE-COVID) - For participants having received booster vaccination: - Immunogenicity of booster vaccination 4 weeks (± 1 week) after boost as confirmed by the presence of anti-SARS-CoV-2-specific antibodies, i.e. positivity in ser | — |
Countries
Germany
Contacts
Public ContactMed. Klinik m. S. Infektiologie
Charité - Universitätsmedizin Berlin
Outcome results
None listed