COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05405283

Odile Launay

Not reported

2022-06-06

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: age ≥ 60 years. adult in good health or with a stable health status if pre-existing medical history. stable health status is defined as an existing disease that has not required a significant change in treatment or hospitalisation for worsening in the 3 months prior to inclusion, and for which no significant change in treatment or hospitalisation for worsening of the disease is envisaged in the near future. for participants over 60 years of age who participated in coviboost, to have received a booster dose of mrna vaccine (pfizer-biontech) administered at least 6 months before the 2nd booster dose not included in coviboost (new participants to be recruited) and having received 2 doses of mrna vaccine (pfizer-biontech) with an interval of 3 to 6 weeks and a 1st booster dose of mrna vaccine (pfizer-biontech) or moderna administered at least 6 months before the 2nd booster dose understands and agrees to comply with the study procedures. written informed consent signed by the participant and the investigator. person affiliated to a social security scheme.

acute febrile infection (body acute febrile infection (body temperature ≥ 38.0°c) within the previous 72 hours and/or had symptoms suggestive of covid-19 within the last 28 days or had case contact within the last 10 days before the inclusion visit. virologically documented (pcr or serology) history of covid 19. immunosuppressive drugs such as corticosteroids at a dosage > 10 mg prednisone equivalent/day (excluding topical preparations and inhalers) within 3 months prior to inclusion or within 6 months for chemotherapies. treated with immunoglobulin or other blood product within 3 months prior to inclusion or scheduled for administration of immunoglobulin or blood product before the end of the study. known hiv, hcv or hbv infection. any condition, such as cancer, that may reduce the immune response. use of experimental ig, experimental monoclonal antibodies or convalescent serum is not allowed during the study. history of severe adverse reactions after vaccine administration including anaphylactic reaction and associated symptoms such as rash, difficulty breathing, angioedema and abdominal pain, or a history of an allergic reaction that may be exacerbated by a component of the sars-cov-2 vaccine during the first vaccine injection. participant having been vaccinated against bcg in the previous year. having received a vaccination within 2 weeks prior to the 2nd booster dose or scheduled to receive a licensed vaccine 2 weeks after the 2nd booster dose. any bleeding disorder considered as a contraindication to an intramuscular injection, previous phlebotomy or receipt of anticoagulants. participation in other research involving humans (french classification jardé 1 or jardé 2) within 4 weeks prior to the inclusion visit, or participation in any other vaccine trial. subject under legal protection (e.g. guardianship, tutorship).

2

Assistance Publique - Hôpitaux de Paris

60

100

France

Healthy volunteers

N/A

189

Immunogenicity of a second booster 15 days after receiving the second booster

None

Phase 3

[{"arm_notes": "", "treatment_id": 2512, "treatment_name": "Cov2 pres dtm", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1875, "treatment_name": "Bnt162b2.b.1.351", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]