COVID-19 trials registries data warehouse

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

University College Dublin - Department of Infectious Diseases

paddy.mallon@ucd.ie

2021-09-29

Recruiting

RCT

Randomized

Adaptive

Open label

multi-center

Prevention

-Adults aged 18 years or above at baseline -Be no more than 9 months (+/- 6 weeks) from the date of second dose of BNT162b2 vaccine at the time of consent -Have received two homologous doses as primary vaccination against SARS CoV-2 with BNT162b2 vaccine (vaccination status should be documented). -No contra-indication against any of the vaccine products in the trial. -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 booster 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 principal investigator or employed by the sponsor or principal investigator -Where a subject received primary vaccination not with two doses of the BNT162b2 mRNA vaccine or the primary vaccination was with two different vaccine products as 1st and 2nd vaccination doses (heterologous vaccination scheme) -Any contraindication to the vaccines in the trial at the moment of randomization 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 Annex A. -Use of drugs with significant interaction with the investigational product -Subjects who are pregnant -Unwillingness 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 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) o Double barrier methods

4

University College Dublin

18

100

Belgium;Denmark;Germany;Ireland;Netherlands;Norway;Spain;Sweden;Switzerland

Healthy volunteers

N/A

40

The primary endpoint comprises a composite endpoint of either an increase in anti-RBD antibody titre to ≥500 IU/mL at day 14 post 3rd dose booster vaccine in those with anti-RBD antibody titre of ≤500 IU/mL immediately before 3rd dose booster vaccination or a 2-fold increase in anti-RBD antibody titre at day 14 following 3rd dose vaccination in those with anti-RBD titre of ≥500 IU/mL immediately before 3rd 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": "different booster strategies", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "different booster strategies", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "different booster strategies", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "different booster strategies", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]