Immune response of COVID-19 vaccines in medical staff and special risk populations

Phase 1

• Conditions: SARS-CoV-2 immunogenicity; MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-001512-28-DE
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-13
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3050

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified