Severe Acute Respiratory Syndrome Coronavirus 19 (COVID-19/SARS-CoV-2) MedDRA version: 23.1 Level: PT Classification code 10084457 Term: COVID-19 immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 23.0 Level: LLT Classification code 10084462 Term: SARS-CoV-2 vaccination System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
Pharmaceutical Form: Concentrate for dispersion for injection
Trade Name:
Sponsors
University College Dublin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults aged 18 years or above at baseline - Be at least three but no more than 7 months from the date prior dose of mRNA vaccine at the time of consent - Have received at least three doses of mRNA vaccines (either Pfizer COMIRNATY® (BNT162b2) vaccine or Moderna Spikevax® vaccine) as primary vaccination against SARSCoV- 2 (vaccination status should be documented). - Written informed consent from the subject has been obtained. 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 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: - Unable to provide written, informed consent - Participation in any other interventional trials - Any significant or uncontrolled disease posing a risk with vaccination as judged by the investigator (including recent, confirmed positive SARS-CoV-2 test within the previous three weeks) - Any significant medical condition that in the opinion of the investigator would necessitate booster vaccination against SARS-CoV-2 within the trial timelines - Any kind of dependency on the sponsor or principal investigator or be directly employed by the principal investigator - Where a subject's primary vaccination and any booster vaccination was not with an mRNA vaccine - Any contraindication to the vaccines in the trial as per the Summary of Medicinal Product Characteristics (SmPC) or the Investigator’s Brochure, if appropriate, including known or suspected allergic reaction or hypersensitivity to any component of the vaccine. A list of contraindications (including prior anaphylaxis to BNT162b2) are listed in the SmPC - Subjects with known bleeding disorders that would, in the opinion of the investigator, be a contraindication to intramuscular injection - Subjects who have received any blood/plasma products or immunoglobulins within 60 days prior to enrolment or who plan to receive during the study period - Use of drugs with significant interaction with the investigational product as per the SmPC - Subjects who are pregnant and who are planning to become pregnant - Nursing mothers - Women of child-bearing potential (i.e. who are not post-menopausal (see below)) who are unwilling to use highly effective contraceptive methods. The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly-effective: o Oral hormonal contraception prescribed for inhibition of ovulation o Dermal hormonal contraception associated with inhibition of ovulation o Vaginal hormonal contraception (NuvaRing®) associated with inhibition of ovulation o Contraceptive plaster associated with inhibition of ovulation o Long-acting injectable contraceptives associated with inhibition of ovulation o Implants that release progesterone (Implanon®) associated with inhibition of ovulation o Tubal ligation (female sterilisation) o Intrauterine devices that release hormones (hormone spiral) This means that the following are not regarded as safe: condom plus spermicide, simple barrier methods (vaginal pessaries, condom, female condoms), copper spirals, the rhythm method, basal temperature method, and the withdrawal method (coitus interruptus). Definition of post-menopausal status: For the purposes of this trial, postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A prior documented high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women with no menses for 12 months who are not using hormonal contraception or hormonal replacement therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the need for, optimal timing of, and immune response after administering a mRNA booster vaccination dose against SARS-CoV-2 in the general population (18+ years) already vaccinated with the mRNA vaccines.;Secondary Objective: 2. To determine the change in cellular immune response measured by a direct from blood qPCR based T-cell activation (dq-TACT) assay at 14 days after booster dose vaccine in comparison to prior to booster dose vaccination. 3. To correlate humoral immune response, cellular immune responses and viral neutralising capacity against wild type SARS-CoV-2 4. To determine the durability of humoral and cellular immune responses after 3rd dose of initial vaccination and shorter term responses to booster dose vaccination 5. To determine rates of, and maximum disease severity associated with confirmed SARSCoV- 2 infections occurring after enrolment in study participants before and after booster dose vaccine 6. To explore primary and secondary endpoints stratified by incident infection pre-booster dose vaccine or by any modification of vaccine epitope.;Primary end point(s): The primary endpoint comprises a composite endpoint of either an increase in anti-RBD antibody titre to =500 IU/mL at day 14 post booster dose vaccine in those with anti-RBD antibody titre of =500 IU/mL immediately before booster dose vaccination or a 2-fold increase in anti-RBD antibody titre at day 14 following booster dose vaccination in those with anti-RBD titre of =500 IU/mL immediately before booster dose vaccination, as measured by quantitative immunoassay targeting the anti-RBD antibody;Timepoint(s) of evaluation of this end point: 14 days after booster dose vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The proportion of subjects reporting positive tests (PCR and/or antigen tests) for SARS-CoV-2 at each reporting time point after enrolment • The proportion of subjects who receive booster dose vaccination at each specific timepoint that achieve a 2-fold increase in RBD antibody titre 14 days after the booster dose vaccine • The proportion of subjects who receive booster dose vaccination at each specific timepoint that achieve an anti-RBD antibody titre =500 IU/mL 14 days after the booster dose vaccine • Rate of 2-fold RBD antibody titre increase following booster dose vaccination measured by quantitative immunoassay targeting the spike 1 (S1) and nucleocapsid (NC) antibodies at 14 days after booster dose vaccine as compared to immediately before vaccination • Analysis stratified by incident pre-booster dose SARS-CoV-2 infections and any modification of vaccine epitope ;Timepoint(s) of evaluation of this end point: 14 days after booster dose vaccine | — |
Countries
Germany, Ireland, Norway, Spain
Contacts
Public ContactDepartment of Infectious Diseases
University College Dublin
Outcome results
None listed