COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-004889-35/DE

University College Dublin - Department of Infectious Diseases

crc@ucd.ie

2022-05-03

Recruiting

RCT

Randomized

Adaptive

Open label

multi-center

Prevention

Adults aged 18 years or above at baseline Be at least three but no more than 6 months (+/- 4 weeks) from the date of 3rd dose of BNT162b2 vaccine at the time of consent Have received three homologous doses as primary vaccination against SARS-CoV-2 with BNT162b2 vaccine (vaccination status should be documented). Written informed consent from the subject has been obtained.

- Unable to provide written, informed consent - Participation in any other interventional trials - People who have already received a fourth dose COVID-19 vaccination - 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 third dose vaccination was not with the BNT162b2 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. A list of contraindications (including prior anaphylaxis to BNT162b2) are listed in the SmPC - 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 o Vaginal hormonal contraception (NuvaRing®) o Contraceptive plaster o Long-acting injectable contraceptives o Implants that release progesterone (Implanon®) 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.

4

University College Dublin

18

100

Ireland

Healthy volunteers

N/A

60

The primary endpoint comprises a composite endpoint of either an increase in anti-RBD antibody titre to ≥500 IU/mL at day 14 post 4th dose booster vaccine in those with anti-RBD antibody titre of ≤500 IU/mL immediately before 4th dose booster vaccination or a 2-fold increase in anti-RBD antibody titre at day 14 following 4th dose vaccination in those with anti-RBD titre of ≥500 IU/mL immediately before 4th dose booster vaccination, as measured by quantitative immunoassay targeting the anti-RBD antibody.

Declared number of arm (4.0) differs from found arms (1.0)

Phase 2

[{"arm_notes": null, "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": null, "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": null, "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Control", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]