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

StatusNot Yet Recruiting
PhasePhase 2
Started2026-12-01
View on ClinicalTrials.gov ↗

Amendment history

2026-02-06
minor
Study Identification, Study Status, Sponsor/Collaborators v1
Collaborators3 to 2 entries
National Institute of Allergy and Infectious Diseases (NIAID)
2026-01-29
minor
Original filing
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.
Trial Details
NCT Number NCT07390968
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: Arcturus Therapeutics, Inc., Seqirus
Conditions Hematopoietic and Lymphatic System Neoplasm
Enrollment 56 participants
Start Date 2026-12-01
Primary Completion 2028-09-01 (estimated)
Study Completion 2029-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-17