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Trial - NCT05081271


Column Value
Trial registration number NCT05081271
Full text link
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05081271

First author
Last imported at : Nov. 22, 2022, noon
Source : ClinicalTrials.gov

None

Contact
Last imported at : Nov. 22, 2022, noon
Source : ClinicalTrials.gov

None

Registration date
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

2021-10-18

Recruitment status
Last imported at : Nov. 22, 2022, noon
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Nov. 22, 2022, noon
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Feb. 8, 2022, 2:30 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Feb. 8, 2022, 2:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: diagnosis of clinically definite multiple sclerosis (cdms) by the 2017 mcdonald criteria 38; age greater than or equal to 18 years; ability to travel to griffin hospital for phlebotomy and booster vaccination; completion of an initial covid-19 vaccine series at least 4 weeks prior to booster randomization (i.e., two doses of either bnt162b2 or mrna-1273, or one dose of ad26.cov2.s); prior negative test for covid-19 spike protein antibodies using a commercial assay; willing to undergo a booster vaccination with either bnt162b2, mrna-1273 or ad26.cov2.s.

Exclusion criteria
Last imported at : Feb. 8, 2022, 2:30 p.m.
Source : ClinicalTrials.gov

inability to give consent; non-fluency in english; inability to adhere to the protocol; anticipated life expectancy of less than six months; lack of a primary care physician or treating neurologist; taking an immunosuppressive medication or chemotherapy for any other conditions aside fromms; presence of another autoimmune condition requiring treatment; active treatment for cancer; history of heavy alcohol use within the past year, as defined by the following criteria: men: 5 or more alcoholic beverages per session or per day, or 15 or more per week; women: 4 or more alcoholic beverages per session or per day, or 8 or more per week; history of illicit drug abuse, e.g., cocaine, heroin, pcp, and/or narcotics within the past year; any condition that would jeopardize the safety or rights of the subject, make it unlikely for the subject to complete the study, or confound the study results. anaphylactic or other severe reaction to a previously administered covid-19 vaccine; ms relapse or worsening symptoms after initial covid-19 vaccination. positive urine pregnancy test at screening [women only]. test is waived in women who are post-menopausal or incapable of conception.

Number of arms
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

9

Funding
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

Griffin Hospital

Inclusion age min
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Feb. 8, 2022, 2:30 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

High risk patients

Severity scale
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Nov. 22, 2022, noon
Source : ClinicalTrials.gov

10

primary outcome
Last imported at : Feb. 8, 2022, 2:30 p.m.
Source : ClinicalTrials.gov

Percent who test positive for COVID-19 spike protein antibodies following booster

Notes
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 8, 2022, 2:30 p.m.
Source : ClinicalTrials.gov

Phase 1

Arms
Last imported at : Oct. 19, 2021, 4 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Homologous booster", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Homologous booster", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Homologous booster", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Heterologous booster; prior vaccinated with Ad26.COV2.S", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Heterologous booster; prior vaccinated with Ad26.COV2.S", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Heterologous booster; prior vaccinated with BNT162b2", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Heterologous booster; prior vaccinated with BNT162b2", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Heterologous booster; prior vaccinated with mRNA-1273", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Heterologous booster; prior vaccinated with mRNA-1273", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]