COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04889209

None

None

2021-05-17

Completed

nonRCT

Non-randomized

Parallel

Open label

multi-center

Prevention

inclusion criteria: participants must meet all of the following criteria to be eligible to participate in this study: individuals >/= 18 years of age at the time of consent. received and completed primary mrna covid-19 vaccine under eua dosing guidelines and one or two doses of ad26.cov2.s at least 12 weeks prior to enrollment (cohort 1 only). willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures. determined by medical history, targeted physical examination and clinical judgement of the investigator to be in good health.* * note: healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. female participants of childbearing potential may be enrolled in the study, if all of the following apply: practiced adequate contraception for 28 days prior to the first dose of vaccine (day 1), has agreed to continue adequate contraception through 3 months following the booster dose, has a negative pregnancy test at screening and on the day of the first study vaccine dose (day 1), is not currently breastfeeding.

participants meeting any of the following criteria will be excluded from the study: known history of sars-cov-2 infection. (for cohort 1 and the primary series of cohort 2). prior administration of an investigational coronavirus (sars coronavirus (sars-cov), middle east respiratory syndrome (mers-cov)) vaccine or sars coronavirus 2 (sars-cov-2) monoclonal antibody in the preceding 90 days or current/planned simultaneous participation in another interventional study. receipt of sars coronavirus 2 (sars-cov-2) vaccine prior to study entry (cohort 2 only). a history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine or nanolipid particles. receipt of any investigational study product within 28 days prior to enrollment. received or plans to receive a vaccine within 28 days prior to the first dose (day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of study vaccine (with exception for seasonal influenza vaccine within 14 days of study vaccine). bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular injections or blood draws, or previously experienced thrombosis with thrombocytopenia (tts) or heparin-induced thrombocytopenia. current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition. received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids >/= 20 milligram per day of prednisone equivalent). topical tacrolimus is allowed if not used within 14 days prior to day 1. received immunoglobulin, blood-derived products, within 90 days prior to first study vaccination. an immediate family member or household member of this study's personnel. is acutely ill or febrile 72 hours prior to or at vaccine dosing (fever defined as >/= 38.0 degrees celsius or 100.4 degrees fahrenheit). participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.

18

National Institute of Allergy and Infectious Diseases (NIAID)

18

99

United States

Healthy volunteers

N/A

867

Magnitude of SARS-CoV-2 specific antibody binding and neutralization titers;Occurrence of adverse events (AEs);Occurrence of Adverse Events of Special Interest (AESIs).;Occurrence of New-Onset Chronic Medical Condition (NOCMCs).;Occurrence of Related Medically attended adverse events (MAAEs).;Occurrence of Serious Adverse Events (SAEs).;Occurrence of solicited reactogenicity adverse events (AEs);Occurrence of solicited reactogenicity adverse events (AEs);Response rate of SARS-CoV-2 specific antibody binding and neutralization titers

None

Phase 1/Phase 2

[{"arm_notes": "Participants that previously (>/=12 weeks) received Ad26.COV2-S 5x10^10 vp ", "treatment_id": 825, "treatment_name": "Mrna-1273.211", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Participants that previously (>/=12 weeks) received BNT162b2 at 30 mcg ", "treatment_id": 825, "treatment_name": "Mrna-1273.211", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Dose 50-mcg. Participants that previously (>/=12 weeks) received Ad26.COV2-S 5x10^10 vp ", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Dose 50-mcg. Participants that previously (>/=12 weeks) received mRNA-1273 at 100mcg ", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Dose 50-mcg. Participants that previously (>/=12 weeks) received BNT162b2 at 30 mcg ", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Participants that previously (>/=12 weeks) received Ad26.COV2-S 5x10^10 vp ", "treatment_id": 2275, "treatment_name": "Adjuvant+sars-cov-2 rs/matrix-m1 adjuvant", "treatment_type": "Adjuvant+protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Participants that previously (>/=12 weeks) received mRNA-1273 at 100mcg ", "treatment_id": 2275, "treatment_name": "Adjuvant+sars-cov-2 rs/matrix-m1 adjuvant", "treatment_type": "Adjuvant+protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Participants that previously (>/=12 weeks) received BNT162b2 at 30 mcg ", "treatment_id": 2275, "treatment_name": "Adjuvant+sars-cov-2 rs/matrix-m1 adjuvant", "treatment_type": "Adjuvant+protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Dose 100-mcg. Participants that previously (>/=12 weeks) received Ad26.COV2-S 5x10^10 vp ", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Dose 100-mcg. Participants that previously (>/=12 weeks) received mRNA-1273 at 100mcg ", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Dose 100-mcg. Participants that previously (>/=12 weeks) received BNT162b2 at 30 mcg \n", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Participants that previously (>/=12 weeks) received mRNA-1273 at 100mcg ", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Participants that previously (>/=12 weeks) received Ad26.COV2-S 5x10^10 vp ", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Participants that previously (>/=12 weeks) received BNT162b2 at 30 mcg ", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Participants that previously (>/=12 weeks) received mRNA-1273 at 100mcg ", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Participants that previously (>/=12 weeks) received Ad26.COV2-S 5x10^10 vp ", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Participants that previously (>/=12 weeks) received BNT162b2 at 30 mcg ", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Participants na\u00efve to COVID-19 vaccine and infection ", "treatment_id": 2727, "treatment_name": "Ad26.cov2.s+bnt162b2+mrna-1273+mrna-1273.222", "treatment_type": "Non replicating viral vector+rna based vaccine", "pharmacological_treatment": "Vaccine"}]