COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05280158

Michael Y. Shino, MD

Not reported

2022-03-15

Completed

RCT

Randomized

Parallel

Open label

single-center

Prevention

all adult lung transplant recipients (age ≥ 18 at the time of consent) who received all of their covid-19 vaccines after lung transplantation. received three or four doses of either the moderna mrna-1273 or pfizer bnt162b2 vaccine with the last dose received at least 4 months prior to study enrollment. currently receiving standard regimen of three drug immunosuppression with prednisone, tacrolimus and mycophenolate mofetil (cellcept, minimum 250 mg bid) or mycophenolate sodium (myfortic, minimum 180 mg bid). agrees not to receive other investigational agents for prophylaxis against covid-19 including evusheld monoclonal antibodies for at least 30 days after the study vaccine. understands and agrees to comply with the study procedures and provides written informed consent. is in stable health without any new or worsening medical conditions in the opinion of the investigator. female participants of childbearing potential (<1 year since start of menopause) may be enrolled in the study if the participant fulfills all the following criteria: has a negative pregnancy test at visit 1 day 1. has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (day 1). has agreed to continue adequate contraception or practice abstinence through 3 months following the booster injection (day 90). is not currently breastfeeding. adequate female contraception is defined as consistent and correct use of a food and drug administration (fda) approved contraceptive method in accordance with the product label. for example: i. barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide ii. intrauterine device iii. prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or im route iv. sterilization of a female participant's monogamous male partner prior to entry into the study v. note: periodic abstinence (e.g., calendar, ovulation methods) and withdrawal are not acceptable methods of contraception.

previous documented covid-19 infection. use of investigational agents for prophylaxis against covid-19 within 90 days of the start of the study, including evusheld monoclonal antibodies. ongoing therapy for acute cellular or antibody mediated rejection. intravenous immunoglobulins (ivig) administration within the prior 3 months or ongoing ivig therapy. anaphylaxis or allergic reaction to any prior vaccines. history of anaphylaxis or other significant adverse reaction requiring medical intervention after receipt of a vaccine. is acutely ill or febrile 24 hours prior to or at the day 1 visit. fever is defined as a body temperature ≥ 38.0°c/100.4°f. 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. pregnant or breastfeeding. has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. known history of hypertension (htn) with systolic blood pressure (bp) > 180 mm hg at the day 1 visit. known history of hypotension with systolic blood pressure < 85 mm hg at the day 1 visit. bleeding disorder considered a contraindication to im injection or phlebotomy. active malignancy diagnosed within previous 4 years (excluding non-melanoma skin cancer). received a major surgery including lung transplantation in the past 3 months.

3

University of California, Los Angeles

18

100

United States

High risk patients

N/A

19

Frequency and grade of each solicited local and systemic reactogenicity AE will be recorded on a daily diary using the FDA Toxicity Grading Scale and collected from Day 1 until Day 7.;Frequency and grade of each unsolicited adverse events (AEs) will be recorded on a daily diary and collected from Day 1 until Day 30.;Frequency of any serious adverse experiences (SAEs) and adverse events of special interests (AESIs) will be collected from Day 1 until Day 180.

None

Phase 1/Phase 2

[{"arm_notes": "Standard-dose", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Mid-Dose", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nanHigh-Dose", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]