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

• Register: EUCTR
• Last refreshed on: 5 July 2021
• Main ID: EUCTR2021-003618-37-NO
• Date of registration: 28/06/2021
• Prospective Registration: Yes
• Primary sponsor: Oslo University Hospital
• Public title: Booster dose of SARS-CoV-2 vaccine to patients with suboptimal response to previous doses.
• Scientific title: REVACCINATION OF IMMUNOSUPPRESSED PATIENTS WITH POOR/NO SARS-COV-2 VACCINE RESPONSE.
• Date of first enrolment: 30/06/2021
• Target sample size: 1000
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-003618-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Norway

Contacts

• Name: John Torgils Vaage
• Affiliation: Oslo University Hospital

• Name: John Torgils Vaage
• Affiliation: Oslo University Hospital

Key inclusion & exclusion criteria

Inclusion criteria:
? Patients with impaired humoral immune response to SARS-CoV-2 vaccination.
? Adult patients (=18 years).
? Signed informed consent

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 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion criteria:
? Pregnant or lactating female patients.
? Serious side effect of previous SARS-CoV-2 vaccination



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with immune deficiency without proper response to previous SARS-CoV-2 vaccine doses.
MedDRA version: 20.0 Level: HLGT Classification code 10003816 Term: Autoimmune disorders System Organ Class: 10021428 - Immune system disorders
MedDRA version: 20.0 Level: PT Classification code 10074555 Term: Transplantation complication System Organ Class: 10022117 - Injury, poisoning and procedural complications
MedDRA version: 20.0 Level: HLT Classification code 10003921 Term: B-cell unclassifiable lymphomas System Organ Class: 100000004851

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Trade Name: Comirnaty
Product Name: SARS-CoV-2 mRNA
Pharmaceutical Form: Concentrate for dispersion for injection

Trade Name: Spikevax
Product Name: SARS-CoV-2 mRNA
Pharmaceutical Form: Concentrate and solvent for solution for injection

Primary Outcome(s)

Main Objective: Investigate the immune response of additional SARS-CoV-2 vaccine doses in immunosuppressed patients with no or suboptimal vaccine response.
Investigate adverse events potentially linked to the additional vaccine dose.

Primary end point(s): Efficacy: Change in SARS-CoV-2 SPIKE/RBD IgG antibody levels 3-5 weeks after administration of additional vaccine doses.
Safety: Hospital admissions due to vaccine adverse events.

Secondary Objective: As per each individual subprotocol

Timepoint(s) of evaluation of this end point: 3-5 weeks after administration of additional vaccine doses

Secondary Outcome(s)

Secondary end point(s): Humoral and cellular immune responses at additional timepoints and other endpoints as defined by respective subprotocol.

Timepoint(s) of evaluation of this end point: Up to 5 years after additional vaccine dose.

Secondary ID(s)

SARS-CoV-2_booster_IS

Source(s) of Monetary Support

Oslo University Hospital

Ethics review

Status: Approved
Approval date: 30/06/2021
Contact: