{"id":"nct:NCT07390968","kind":"trial","title":"Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Patients","authors":["Fred Hutchinson Cancer Center"],"author_count":1,"year":2026,"published":"2026-02-05","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT07390968","source_url":"https://clinicaltrials.gov/study/NCT07390968","archive_url":"https://space-kitty.com/papers/nct:NCT07390968","updated":"2026-09-17","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"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.","abstract_license":"ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters","license":"ClinicalTrials.gov terms (attribution, processing date, modifications noted)","is_open_access":true,"retracted":false,"peer_reviewed":null,"categories":["Hematopoietic and Lymphatic System Neoplasm"],"details":{"acronym":null,"status":"NOT_YET_RECRUITING","phase":"PHASE2","study_type":"INTERVENTIONAL","enrollment":56,"sponsor":"Fred Hutchinson Cancer Center","conditions":["Hematopoietic and Lymphatic System Neoplasm"],"interventions":["BIOLOGICAL: SARS-CoV-2 mRNA Vaccine ARCT-021","BIOLOGICAL: Tozinameran","PROCEDURE: Biospecimen Collection","OTHER: Electronic Health Record Review","OTHER: Survey Administration"],"start_date":"2026-12-01","start_date_type":"ESTIMATED","primary_completion_date":"2028-09-01","has_results":false,"data_source":"ClinicalTrials.gov","data_processed":"2026-10-29T09:00:05","modifications":"selected fields only; whitespace normalized; brief summary truncated to 2,000 characters"},"provenance":"clinicaltrials","attribution":"Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.","topics":[{"slug":"mrna-cancer-vaccines","name":"mRNA Therapeutics & Cancer Vaccines","domain_slug":"medicine"}],"cited_in_dossiers":[{"slug":"mrna-cancer-vaccines","title":"mRNA Therapeutics & Cancer Vaccines: State of the Field (October 2026)","url":"https://space-kitty.com/dossiers/mrna-cancer-vaccines"}]}