Booster dose of SARS-CoV-2 vaccine to patients with suboptimal response to previous doses.

Phase 1

• Conditions: Patients with immune deficiency without proper response to previous SARS-CoV-2 vaccine doses.; MedDRA version: 20.0Level: HLGTClassification code 10003816Term: Autoimmune disordersSystem Organ Class: 10021428 - Immune system disorders; MedDRA version: 20.0Level: PTClassification code 10074555Term: Transplantation complicationSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 20.0Level: HLTClassification code 10003921Term: B-cell unclassifiable lymphomasSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2021-003618-37-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-28
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 11000

Inclusion Criteria

•Patients already included in one of the following ongoing vaccine observational subprotocols:
•SARS-CoV-2 cellular and humoral immune response following vaccination of kidney transplant recipients and healthy controls
•SARS-CoV-2 serological vaccine response in patients at Oslo University Hospital
•Vaccine responses in MS: Nevrovax.
•A Norwegian study of vaccine response to COVID-19 vaccines in patients using immunosuppressive medication within rheumatology and gastroenterology – The Nor-vaC study
•Immunological response to Covid-19 vaccination in Lymphoma patients treated with Rituximab and in Bone marrow Transplanted patients.
•Patients with an interval between the first and second vaccine dose according to drug label; 3 weeks for Comirnaty and 4 weeks for SpikeVax.
•Patients with no or impaired humoral immune response more than 3 weeks after two doses of SARS-CoV-2 mRNA vaccine (SARS-CoV-2 SPIKE IgG =100 AU).
•Available for vaccination at a few centralized centers (OUS, AHUS, Diakonhjemmet Hospital, HUS).
•Not participating in therapeutical intervention studies.
•Adult patients (=18 years).
•For fourth dose: Solid organ transplant recipients with no or impaired humoral immune response 4 weeks after three doses of SARS-CoV-2 mRNA vaccine (SARS-CoV-2 SPIKE IgG =100 AU).

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 6500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4500

Exclusion Criteria

•The second/third vaccine dose less than 4 weeks prior to vaccination with the third/fourth dose.
•Pregnant patients or women of childbearing potential (WOCBP) not on highly effective contraception (not acceptable methods: progesterone-only oral hormonal contraception, male/female condom without spermicide or cap, diaphragm or sponge with spermicide).
•Solid organ transplant recipients transplanted less than 6 months before the third dose vaccination.
•Serious side effect of previous SARS-CoV-2 vaccination.
•Allergic to any vaccine excipients.
•Acute febrile illness or acute infection.
•Received any vaccination against other infectious diseases within the last four weeks prior to the third dose.
•Have experienced breakthrough SARS-CoV-2 infection during or following primary vaccination.
•Participation in other vaccine studies.

Study & Design

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