Trial · NCT07390968
Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Patients
NCT07390968, Phase 2, Not yet recruiting, Fred Hutchinson Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Patients. Trials, record NCT07390968. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07390968
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Patients
- NCT number
- NCT07390968
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 56 participants, estimated
- Lead sponsor
- Fred Hutchinson Cancer Center
- Conditions
- Hematopoietic and Lymphatic System Neoplasm
- Interventions
- SARS-CoV-2 mRNA Vaccine ARCT-021, Tozinameran, Biospecimen Collection, Electronic Health Record Review, Survey Administration
- First posted
- 2026-02-05
- Last updated
- 2026-09-17
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Geometric mean titer (GMT) of neutralizing antibody (nAb) against spike protein matching the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant | At 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. |
| Secondary | Percentage of participants with one or more solicited local or systemic reactogenicity signs and symptoms | For up to 7 days following each vaccination | 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. |
| Secondary | Percentage of participants with unsolicited adverse events (AEs) | Up to 28 days following each vaccination | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Seroresponse rates | At 28-84 days after each vaccine dose, and at 6 months after the last dose | 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. |
| Secondary | Quantitative levels of anti-Spike T cell responses | At 28-84 days after each vaccine dose, and at 6 months after the last dose | Will be based on a validated intracellular cytokine staining assay demonstrating interferon-γ, interleukin-2, or both. |
| Secondary | New events of late-acute or chronic graft-versus-host disease (GVHD) of grade 3 or higher | Up to day 141 | Will compute the cumulative incidence of late-acute or chronic GVHD of grade 3 or higher by randomization arm using time-to-event methods. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| K24AI190345 | Infection prevention strategies after CAR-T cell therapy | HILL, JOSHUA AIDEN | FRED HUTCHINSON CANCER CENTER | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07390968
GET https://conductscience.org/api/trials/v1/NCT07390968/registered