COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-003618-37/NO

Oslo University Hospital - John Torgils Vaage

jtvaage@ous-hf.no

2021-06-28

Recruiting

nonRCT

Non-randomized

Single group assignment

Open label

multi-center

Prevention

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).

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.

1

Oslo University Hospital

18

100

Norway

High risk patients

N/A

11000

Efficacy: SARS-CoV-2 SPIKE/RBD IgG antibody levels 4 weeks after administration of the third vaccine dose. Safety: Hospital admissions or deaths due to vaccine adverse events 6 weeks after the third/fourth dose.

Declared number of arm (1.0) differs from found arms (2.0)

Phase 4

[{"arm_notes": "Additional booster dose", "treatment_id": 1153, "treatment_name": "Sars-cov-2 mrna vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]