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LUNAR-COV19 vs. Comirnaty for Transplant Patients

This study is comparing two COVID-19 vaccines, LUNAR-COV19 and Comirnaty, in adults who have recently received a hematopoietic cell transplant (HCT). HCT patients often don't respond as well to vaccines as healthy people. LUNAR-COV19 is a special type of mRNA vaccine that can make more copies of itself, which might lead to a stronger immune response against the SARS-CoV-2 virus (which causes COVID-19). The researchers want to see if LUNAR-COV19 works better than Comirnaty in these patients by measuring the amount of protective antibodies (neutralizing antibodies) in their blood. You may be able to join if you are 18 or older, had an HCT within the last year, and meet other health requirements.

Study design
This is an interventional study where participants are randomly assigned to receive one of two vaccines. It plans to enroll 56 adult patients.
What's involved
You would receive three vaccine doses over about four months. You would also have nasal swabs and blood samples collected throughout the study.
Compensation
Not stated in the trial record.
Follow-up
After your last vaccine dose, you will be followed up at several points, with the final follow-up around 281 days after the first dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07390968

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

Not Yet Recruiting
PHASE2Ages 18+InterventionalPrevention
Fred Hutchinson Cancer Center
~56 participants
Updated 2026-02-09 on ClinicalTrials.gov
What's tested:SARS-CoV-2 mRNA Vaccine ARCT-021TozinameranBiospecimen CollectionElectronic Health Record ReviewSurvey Administration

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Geometric mean titer (GMT) of neutralizing antibody (nAb) against spike protein matching the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant
Measured over At 28 days after the third vaccine dose, assessed up through day 141

Conditions

Hematopoietic and Lymphatic System Neoplasm

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Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washingtonstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Joshua Hill, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Joshua Hill, MD
[email protected]
206-667-6504
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Geometric mean titer (GMT) of neutralizing antibody (nAb) against spike protein matching the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variantAt 28 days after the third vaccine dose, assessed up through day 141

    Will compare log10-transformed SARS-CoV-2 nAb titers at 28 days following the third vaccination (day 141) between study arms using linear mixed effects models with fixed effects for time points when nAb titers are measured up until day 141 (days 29, 113, and 141; baseline as the reference category), study arm, the interaction between time points and study arm, and stratification variables (time since hematopoietic cell transplantation \[HCT\] and site). Subject-specific random effects will be included. Model estimates will be exponentiated and presented as a ratio of GMTs, with 90% confidence intervals, to correspond with the two-sided alpha of 0.10 used for power calculations.