Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-00148 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20962 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Arcturus Therapeutics, Inc. | INDUSTRY |
| Seqirus | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
ARM 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.
ARM 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.
After completion of study treatment, patients are followed up at days 115, 120, 127, 141 and 281.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 mRNA Vaccine ARCT-021 | Biological | Given IM |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joshua Hill, MD | Contact | 206-667-6504 | jahill3@fredhutch.org |
| Name | Affiliation | Role |
|---|---|---|
| Joshua Hill, MD | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be blinded to the treatment assignment, All investigative study center personnel involved in participant evaluations will remain blinded to the treatment assignments
| 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 |
|
| For up to 7 days following each vaccination |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. | At 28-84 days after each vaccine dose, and at 6 months after the last dose |
| 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. | At 28-84 days after each vaccine dose, and at 6 months after the last dose |
| 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 |
| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
Not provided
Not provided