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NCT07390968 · ClinicalTrials.gov registry record · Phase 2
Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Patients
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Not yet
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT07390968: Clinical Trial Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
NCT07390968 is a Phase 2 study that has not yet begun recruiting, run by Fred Hutchinson Cancer Center. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07390968, a Phase 2 study, has not yet begun recruiting, sponsored by Fred Hutchinson Cancer Center.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study 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.
Primary Outcome
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 in
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Survey Administration
- OTHER Electronic Health Record Review
- BIOLOGICAL SARS-CoV-2 mRNA Vaccine ARCT-021
- BIOLOGICAL Tozinameran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2029-01-01 |
| Phase | Phase 2 |
What is known before NCT07390968 opens enrollment
NCT07390968 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07390968 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07390968 about?
NCT07390968 is a clinical study titled "Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Patients". 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 ...
What is the current status of trial NCT07390968?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2026-09-01. Estimated completion is 2029-01-01.
What interventions are being tested in trial NCT07390968?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Survey Administration (OTHER), Electronic Health Record Review (OTHER), SARS-CoV-2 mRNA Vaccine ARCT-021 (BIOLOGICAL), Tozinameran (BIOLOGICAL).
Who is sponsoring clinical trial NCT07390968?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07390968's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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