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

NCT07390968 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: RG1125827NCI-2026-0014820962
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (1)

• Geometric mean titer (GMT) of neutralizing antibody (nAb) against spike protein matching the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant

  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.

  At 28 days after the third vaccine dose, assessed up through day 141

Secondary Outcomes (8)

• Percentage of participants with one or more solicited local or systemic reactogenicity signs and symptoms

  For up to 7 days following each vaccination

• Percentage of participants with unsolicited adverse events (AEs)

  Up to 28 days following each vaccination

• Percentage of participants with one or more serious AEs, or AEs of special interest (AESIs)

  Following first study vaccine dose until 6 months following last vaccination

• nAb GMT against spike protein matching the SARS-CoV-2 variant included in the vaccine

  At 28-84 days after each vaccine dose, and at 6 months after the last dose

• Anti-spike immunoglobulin G GMT against Spike protein matching the SARS-CoV-2 variant included in the vaccine

  At 28-84 days after each vaccine dose, and at 6 months after the last dose

Study Arms (2)

Arm I (LUNAR-COV19)

EXPERIMENTAL

Patients receive LUNAR-COV19 IM on days 1, 29 and 113 in the absence of medical conditions or unacceptable toxicity. Additionally, patients undergo nasal swab at screening and at time of suspected SARS-CoV-2 infection, as well as blood sample collection throughout the study.

Biological: SARS-CoV-2 mRNA Vaccine ARCT-021; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Survey Administration

Arm II (Comirnaty)

EXPERIMENTAL

Patients receive SARS-CoV-2 Comirnaty IM on days 1, 29 and 113 in the absence of medical conditions or unacceptable toxicity. Additionally, patients undergo nasal swab at screening and at time of suspected SARS-CoV-2 infection, as well as blood sample collection throughout the study.

Biological: Tozinameran; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Survey Administration

Interventions

Tozinameran BIOLOGICAL

Given IM

Also known as: BNT 162b2, BNT-162b2, BNT1162b2 SARS-CoV-2 Vaccine, BNT162b2, BNT162b2 (Pfizer-BioNTech), BNT162b2 COVID-19 Vaccine, Comirnaty, Pfizer COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine, Pfizer/BioNTech COVID-19 Vaccine, SARS-CoV-2 SP mRNA LNP Vaccine BNT162b2

Arm II (Comirnaty)

Biospecimen Collection PROCEDURE

Undergo nasal swab and blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected

Arm I (LUNAR-COV19); Arm II (Comirnaty)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (LUNAR-COV19); Arm II (Comirnaty)

Survey Administration OTHER

Ancillary studies

Arm I (LUNAR-COV19); Arm II (Comirnaty)

SARS-CoV-2 mRNA Vaccine ARCT-021 BIOLOGICAL

Given IM

Also known as: ARCT 021, ARCT-021, ARCT-021 COVID-19 Vaccine, ARCT-021 SARS-CoV-2 Vaccine, ARCT021, LUNAR-COV19

Arm I (LUNAR-COV19)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Arcturus Therapeutics, Inc.: collaborator
• Seqirus: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

BNT162 Vaccine

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Joshua Hill, MD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Hill, MD

CONTACT

206-667-6504; jahill3@fredhutch.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be blinded to the treatment assignment, All investigative study center personnel involved in participant evaluations will remain blinded to the treatment assignments
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)