Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07390968 | Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Patients | PHASE2 | NOT YET_RECRUITING | 56 | — | — | Sep 1, 2026 | Jan 1, 2029 | Feb 9, 2026 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Arm I (LUNAR-COV19) | EXPERIMENTAL | Patients receive LUNAR-COV19 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. |
| Arm II (Comirnaty) | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| SARS-CoV-2 mRNA Vaccine ARCT-021 | BIOLOGICAL | Given IM |
| Tozinameran | BIOLOGICAL | Given IM |
| Biospecimen Collection | PROCEDURE | Undergo nasal swab and blood sample collection |
| Electronic Health Record Review | OTHER | Ancillary studies |
| Survey Administration | OTHER | Ancillary studies |
Inclusion Criteria: * 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 malignanc...