[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07390968":3,"trial-entities:NCT07390968":162,"trial-summary:NCT07390968":165},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":73,"secondary_outcomes":78,"sex":106,"minimum_age":107,"maximum_age":108,"healthy_volunteers":109,"eligibility_criteria":110,"std_ages":135,"locations":138,"central_contacts":156,"overall_officials":158,"references":160,"see_also_links":161},"NCT07390968","RG1125827","Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Patients","A Phase 2, Multicenter, Double-Blind, Randomized, Controlled Trial of the Safety and Immunogenicity of a Self-Amplifying mRNA COVID-19 Vaccine in Adult Hematopoietic Cell Transplant Recipients","NOT_YET_RECRUITING","2029-01-01","2026-01","2026-09-17","2026-12-01","Fred Hutchinson Cancer Center","OTHER",true,"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.","OUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients receive LUNAR-COV19 intramuscularly (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.\n\nARM II: 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.\n\nAfter completion of study treatment, patients are followed up at days 115, 120, 127, 141 and 281.",[19],"Hematopoietic and Lymphatic System Neoplasm",[],"INTERVENTIONAL","PREVENTION",[24],"PHASE2",{"count":26,"type":27},56,"ESTIMATED",[29,42,58,66,70],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"BIOLOGICAL","SARS-CoV-2 mRNA Vaccine ARCT-021","Given IM",[34],"Arm I (LUNAR-COV19)",[36,37,38,39,40,41],"ARCT 021","ARCT-021","ARCT-021 COVID-19 Vaccine","ARCT-021 SARS-CoV-2 Vaccine","ARCT021","LUNAR-COV19",{"type":30,"name":43,"description":32,"armGroupLabels":44,"otherNames":46},"Tozinameran",[45],"Arm II (Comirnaty)",[47,48,49,50,51,52,53,54,55,56,57],"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\u002FBioNTech COVID-19 Vaccine","SARS-CoV-2 SP mRNA LNP Vaccine BNT162b2",{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"PROCEDURE","Biospecimen Collection","Undergo nasal swab and blood sample collection",[34,45],[64,65],"Biological Sample Collection","Biospecimen Collected",{"type":14,"name":67,"description":68,"armGroupLabels":69},"Electronic Health Record Review","Ancillary studies",[34,45],{"type":14,"name":71,"description":68,"armGroupLabels":72},"Survey Administration",[34,45],[74],{"measure":75,"description":76,"timeFrame":77},"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",[79,83,87,91,94,96,99,102],{"measure":80,"description":81,"timeFrame":82},"Percentage of participants with one or more solicited local or systemic reactogenicity signs and symptoms","Will tabulate the number and severity of solicited local or systemic reactogenicity signs and symptoms overall and by randomization group. Will compare the probability of at least one solicited local reaction or systemic adverse event after each vaccination dose by randomization arm using generalized linear mixed effects models, with logit link, similar to the models described for the seroresponse outcome.","For up to 7 days following each vaccination",{"measure":84,"description":85,"timeFrame":86},"Percentage of participants with unsolicited adverse events (AEs)","Will tabulate the number and severity of unsolicited AEs overall and by randomization group. Will also report the number and percentage of participants with at least one of each of these types of AEs, by dose, severity, and study arm. The probability of at least one unsolicited AE will be compared between study arms using similar models.","Up to 28 days following each vaccination",{"measure":88,"description":89,"timeFrame":90},"Percentage of participants with one or more serious AEs, or AEs of special interest (AESIs)","Will tabulate the number and severity of serious AEs or AESIs overall and by randomization group. Will also report the number and percentage of participants with at least one of each of these types of AEs, by dose, severity, and study arm. The probability of at least one serious AE or AESI will be compared by study arms using time-to-event methods.","Following first study vaccine dose until 6 months following last vaccination",{"measure":92,"timeFrame":93},"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",{"measure":95,"timeFrame":93},"Anti-spike immunoglobulin G GMT against Spike protein matching the SARS-CoV-2 variant included in the vaccine",{"measure":97,"description":98,"timeFrame":93},"Seroresponse rates","Will be defined as the proportion of participants with a 4-fold or greater increase in nAb titers. Will be compared by study arm using mixed effects models, but with a binomial distribution and logit link, and using the baseline nAb as a covariate rather than a dependent variable. Comparisons from these models will be presented as odds ratios with 95% confidence intervals. Per-protocol (PP) analyses among the PP cohort may be performed as a sensitivity analysis.",{"measure":100,"description":101,"timeFrame":93},"Quantitative levels of anti-Spike T cell responses","Will be based on a validated intracellular cytokine staining assay demonstrating interferon-γ, interleukin-2, or both.",{"measure":103,"description":104,"timeFrame":105},"New events of late-acute or chronic graft-versus-host disease (GVHD) of grade 3 or higher","Will compute the cumulative incidence of late-acute or chronic GVHD of grade 3 or higher by randomization arm using time-to-event methods.","Up to day 141","ALL","18 Years",null,false,{"inclusion":111,"exclusion":120,"raw_text":134},[112,113,114,115,116,117,118,119],"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\u002Fmm\\^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",[121,122,123,124,125,126,127,128,129,130,131,132,133],"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\u002Fkg\u002Fday 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","Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (where locally approved)\n* Have received an allogeneic HCT within the prior 365 days\n* Have no relapse or progression of underlying malignancy\n* Have platelets ≥ 30,000\u002Fmm\\^3\n* Not pregnant (confirmed with negative urine or serum pregnancy test, if applicable)\n* Willingness to take study vaccine and complete necessary study procedures\n* 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\n\nExclusion Criteria:\n\n* Current infection with SARS-CoV-2 or infection within the prior 28 day period\n* Positive for SARS-CoV-2 by nasal swab polymerase chain reaction (PCR) at screening\n* Currently receiving any approved, authorized, or investigational direct-acting antiviral drug against SARS-CoV-2\n* Received any approved, authorized, or investigational monoclonal anti-SARS-CoV-2 antibody therapy within the prior 180 days before screening\n* Received a SARS-CoV-2 vaccine after HCT or within 28 days prior to HCT\n* Participation in any other concurrent clinical trial of an experimental treatment or prevention for SARS-CoV-2\n* Receiving \\> 1 mg\u002Fkg\u002Fday corticosteroids within the prior 7 days\n* Active infection that is not adequately controlled, as determined by the investigator\n* 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\n* Have received immunoglobulin replacement therapy (IGRT) within 30 days of enrollment, or anticipated to receive IGRT within 3 months of enrollment\n* Have a history of suspected or documented myocarditis or pericarditis\n* 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\n* 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",[136,137],"ADULT","OLDER_ADULT",[139],{"facility":140,"city":141,"state":142,"zip":143,"country":144,"contacts":145,"geoPoint":153},"Fred Hutch\u002FUniversity of Washington Cancer Consortium","Seattle","Washington","98109","United States",[146,151],{"name":147,"role":148,"phone":149,"email":150},"Joshua Hill, MD","CONTACT","206-667-6504","jahill3@fredhutch.org",{"name":147,"role":152},"PRINCIPAL_INVESTIGATOR",{"lat":154,"lon":155},47.60621,-122.33207,[157],{"name":147,"role":148,"phone":149,"email":150},[159],{"name":147,"affiliation":140,"role":152},[],[],{"nct_id":4,"conditions":163,"biomarkers":164},[19],[],{"nct_id":4,"found":15,"summary":166,"prompt_version":176},{"design":167,"status":168,"heading":169,"summary":170,"follow_up":171,"word_count":172,"commitments":173,"compensation":174,"drugs_mentioned":175},"This is an interventional study where participants are randomly assigned to receive one of two vaccines. It plans to enroll 56 adult patients.","completed","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.","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.",113,"You would receive three vaccine doses over about four months. You would also have nasal swabs and blood samples collected throughout the study.","Not stated in the trial record.",[],"v2"]