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Vaccine

mRNA-1273 for Leukemia

Phase 2

Waitlist Available

Led By Elad Sharon, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 months

Awards & highlights

Study Summary

This trial is testing a vaccine to see if it can protect people with cancer from COVID-19. The vaccine is given in two doses, four weeks apart. Participants will be monitored for 12 months after the second dose.

Eligible Conditions

Leukemia
Lymphoma
Solid Tumor Cancers
Blood Cancers
Multiple Myeloma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess immunogenicity of m-RNA 1273 administered in 2 doses

Secondary Immunization

Safety and reactogenicity of MRNA-1273 vaccine

Secondary outcome measures

immunogenicity of mrna-1273 vaccine as assessed by neutralizing antibody (nAb)

Side effects data

From 2022 Phase 3 trial • 30415 Patients • NCT04470427

Headache

Fatigue

Upper respiratory tract infection

Injection site pain

COVID-19

100%

80%

60%

40%

20%

Study treatment Arm

Part A (Blinded): Placebo

Part A (Blinded): mRNA-1273

Part B (Open-label): Placebo

Part B (Open-label): Placebo/mRNA-1273

Part B (Open-label): mRNA-1273

Part C: mRNA-1273 Booster

Trial Design

2Treatment groups

Experimental Treatment

Group I: 2Experimental Treatment1 Intervention

100 micrograms (0.5 mL) mRNA-1273 injection on D1

Group II: 1Experimental Treatment1 Intervention

100 mcg (0.5 mL) mRNA-1273 injection (IM) on days 1 and 29; with option for subsequent booster dose(s), 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1273

2021

Completed Phase 4

~58700

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,930,352 Total Patients Enrolled

1,513 Trials studying Leukemia

384,761 Patients Enrolled for Leukemia

Elad Sharon, M.D.Principal InvestigatorNational Cancer Institute (NCI)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is mRNA-1273 a hazard to human health?

"mRNA-1273's safety rating was set at 2 due to limited clinical evidence for both efficacy and harm reduction."

Answered by AI

Are there any remaining opportunities to partake in this research endeavor?

"Yes, the information available from clinicaltrials.gov reveals that this study is actively recruiting participants. It was originally posted on April 28th 2021 and last updated on November 2nd 2022. To date, it has recruited 220 patients over 2 locations."

Answered by AI

Has mRNA-1273 been previously tested in a research setting?

"mRNA-1273 was first trialled at Sundance Clinical Research in 2020, and since then 8 studies have been completed. At present there are 25 active trials occurring around the world, with a substantial number taking place in Bethesda, Maryland."

Answered by AI

Has a similar trial been conducted previously?

"At the present time, mRNA-1273 is being clinically trialed in 22 countries across 218 cities. This endeavour was first initiated by ModernaTX Inc. back in 2020 and included 30 thousand participants during its Phase 3 drug trials stage. Since then, 8 additional examinations have been held for this medication."

Answered by AI

What is the population size of this experimental research?

"Affirmative. According to data hosted on clinicaltrials.gov, the trial was initially uploaded on April 28th 2021 and has been actively seeking participants since then. A total of 220 patients are needed from 2 different medical centres for this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial of the Safety and Immunogenicity of the COVID-19 Vaccine (mRNA-1273) in Participants With Hematologic Malignancies and Various Regimens of Immunosuppression, and in Participants With Solid Tumors on PD1/PDL1 Inhibitor Therapy, Including Boost...

2021. "A Trial of the Safety and Immunogenicity of the COVID-19 Vaccine (mRNA-1273) in Participants With Hematologic Malignancies and Various Regimens of Immunosuppression, and in Participants With Solid Tumors on PD1/PDL1 Inhibitor Therapy, Including Boost...". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04847050.