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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 is a Phase 2 study that has not yet begun recruiting, run by Fred Hutchinson Cancer Center. The registered enrollment target is 56 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07390968
The ClinicalTrials.gov registry entry for NCT07390968 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07390968 reports 0 study locations.
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.
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