COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05170399

Jayson J Grey, R.N.

jayson.doubrava@nih.gov

2021-12-28

Recruiting

nonRCT

Non-randomized

Parallel

Open label

single-center

Prevention

inclusion criteria: diagnosis of cll, fl, mcl, mzl, nhl nos or wm must fulfil one of the following criteria to be enrolled in one study arm per vaccine received: patients with cll and one of the following: i. arm 1: must be treatment naive (no prior cancer directed therapy) ii. arm 2: patients that have received prior cancer directed therapy and are currently not receiving active treatment iii. arm 3: must be receiving treatment with a btki. this arm is not available to patients receiving the heplisav-b vaccine iv. arm 4: must be receiving treatment with a btki for >= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination. this arm is not available to patients who have had a prior episode of disease flare during periods of drug hold, or for patients with cll that is actively progressing. v. arm 5: must be receiving treatment with a bcl-2 inhibitor or patients with fl, mcl, mzl, nhl nos or wm and one of the following: i. arm 1: must currently not be receiving active treatment (treatment na(sqrroot) ve or previously treated) ii. arm 2: must be receiving treatment with targeted therapies (e.g. btki, bcl-2 inhibitors, pi3k inhibitors, immunomodulatory agents, proteasome inhibitors) if prior exposure to hepatitis-b vaccination, must have documentation of negative serologic response age >= 18 years able to comprehend the investigational nature of the protocol and provide informed consent

female patients who are currently pregnant history of severe allergic reaction to vaccines concomitant inherited immunodeficiency any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator s opinion, could compromise the subject s safety or put the study outcomes at undue risk. receive cytotoxic chemotherapy within 2 weeks prior to vaccination receive intravenous immunoglobulin (ivig) within 2 months prior to vaccination receive anti-cd20 and/or anti-cd19 monoclonal antibody therapy within 6 months prior to vaccination receive cellular therapy (e.g. car-t cells) within 12 months prior to vaccination history of allogeneic stem cell transplantation

2

National Heart, Lung, and Blood Institute (NHLBI)

18

100

United States

High risk patients

N/A

500

Serologic response against each administered vaccine following completion of the vaccine series in each study arm

None

Phase 4

[{"arm_notes": "", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]