| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Severe Acute Respiratory Syndrome Coronavirus 19 (COVID-19/SARS-CoV-2) |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 23.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10084457 |
| E.1.2 | Term | COVID-19 immunisation |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 23.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10084462 |
| E.1.2 | Term | SARS-CoV-2 vaccination |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
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. |
|
| E.2.2 | Secondary objectives of the trial |
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. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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. |
|
| E.4 | Principal 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. |
|
| E.5 End points |
| E.5.1 | 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 |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| 14 days after booster dose vaccine |
|
| E.5.2 | 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 |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| 14 days after booster dose vaccine |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| Arm 1 (control group) will not receive a booster dose of vaccination |
|
| E.8.2.4 | Number of treatment arms in the trial | 4 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 14 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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