Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Patients

Starting soon · Phase 2

Conditions studied: Hematopoietic and Lymphatic System Neoplasm

In brief

This phase IIb trial compares the effect of LUNAR-COV19 vaccine to Comirnaty vaccine in treating adult patients who have received a hematopoietic cell transplant (HCT). Guidelines recommend repeating severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccination of 3 messenger ribonucleic acid (mRNA) vaccines followed by a fourth booster 3-6 months after treatment. However, vaccination is less effective in HCT patients compared to healthy people due to impaired immune responses. LUNAR-COV19, a self-amplifying mRNA vaccine, may help the body's own immune system recognize the SARS-CoV-2 spike protein and fight the virus by using a special mRNA that copies itself for a stronger response. Vaccines made from mRNA with SARS-CoV-2, such as Comirnaty, may help the body build an effective immune response. This may provide active protection against SARS-CoV-2 infection. LUNAR-COV19 may be safe and tolerable and may generate a better and more durable immune response than the Comirnaty vaccine in adult patients who have received a HCT.

Key facts

Study ID: NCT07390968
Run by: Fred Hutchinson Cancer Center
People needed: 56
Starts: 2026-09-01
Expected to finish: 2029-01-01
Last updated by the study team: 2026-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Aged ≥ 18 years
Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (where locally approved)
Have received an allogeneic HCT within the prior 365 days
Have no relapse or progression of underlying malignancy
Have platelets ≥ 30,000/mm\^3
Not pregnant (confirmed with negative urine or serum pregnancy test, if applicable)
Willingness to take study vaccine and complete necessary study procedures
If of childbearing potential, must agree to use a highly effective method of birth control or abstain from heterosexual activity for the course of the study through at least 60 days after the last dose of the study vaccine

You may not qualify if…

Current infection with SARS-CoV-2 or infection within the prior 28 day period
Positive for SARS-CoV-2 by nasal swab polymerase chain reaction (PCR) at screening
Currently receiving any approved, authorized, or investigational direct-acting antiviral drug against SARS-CoV-2
Received any approved, authorized, or investigational monoclonal anti-SARS-CoV-2 antibody therapy within the prior 180 days before screening
Received a SARS-CoV-2 vaccine after HCT or within 28 days prior to HCT
Participation in any other concurrent clinical trial of an experimental treatment or prevention for SARS-CoV-2
Receiving > 1 mg/kg/day corticosteroids within the prior 7 days
Active infection that is not adequately controlled, as determined by the investigator
Have received therapies that cause profound T-cell or B-cell depletion within 30 days of enrollment, or anticipated to receive such therapies within 3 months of enrollment
Have received immunoglobulin replacement therapy (IGRT) within 30 days of enrollment, or anticipated to receive IGRT within 3 months of enrollment
Have a history of suspected or documented myocarditis or pericarditis
Any inability to take study vaccine or comply with study procedures that, in the opinion of the investigator, would make the participant unsuitable for the study
Individuals with a known history of severe hypersensitivity reactions, including anaphylaxis, or other significant adverse reactions to any vaccine or any vaccine excipient. Have any other condition that would, in the investigator's judgment, contraindicate participation in the clinical study due to safety concerns with clinical study procedures

Where it is running

Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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