LUNAR-COV19 vs Comirnaty Vaccine for Cancer Patients
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if the new LUNAR-COV19 vaccine can help cancer patients who have undergone a hematopoietic cell transplant (HCT) fight COVID-19 more effectively than the Comirnaty vaccine. Patients who have had an HCT often show a weaker response to vaccines, so researchers are testing whether LUNAR-COV19, which uses a special self-copying mRNA, can enhance their immune response. Participants will receive doses of either the LUNAR-COV19 or Comirnaty vaccine and will be monitored for their ability to combat the virus. This trial may suit individuals who have had an allogeneic HCT in the past year and have not received a COVID-19 vaccine post-transplant. As a Phase 2 trial, this study focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant research.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the LUNAR-COV19 vaccine may be safe and well-tolerated. It is designed to create a strong immune response using a special type of mRNA that can replicate itself. Although researchers are still learning about its safety in humans, the vaccine aims to enhance the body's ability to fight the virus effectively.
For the Comirnaty vaccine, studies have demonstrated that it works well and is generally safe for people with cancer. Common side effects include mild reactions such as soreness at the injection site, tiredness, and headaches. More serious side effects are rare but can include swelling of lymph nodes and autoimmune issues.
Both vaccines are under study to determine their effectiveness in people who have had a hematopoietic cell transplant, as this group may have weaker immune responses. Understanding the safety and effectiveness in these individuals is important. Those considering joining the trial should discuss any concerns with a healthcare provider for more personalized information.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer new possibilities for cancer patients needing COVID-19 protection. LUNAR-COV19 is unique because it utilizes a novel lipid nanoparticle delivery system that could enhance the immune response compared to traditional vaccines. It also potentially offers targeted action with fewer side effects. Comirnaty, a well-known mRNA vaccine, has already shown success in the general population, and this trial will explore its effectiveness specifically in cancer patients, who often have compromised immune systems. These approaches could lead to more effective and safer COVID-19 vaccination strategies for individuals with cancer.
What evidence suggests that this trial's treatments could be effective for cancer patients who have received a hematopoietic cell transplant?
This trial will compare the LUNAR-COV19 vaccine with the Comirnaty vaccine for cancer patients. Research has shown that the Comirnaty vaccine works well for individuals with past or current cancers, achieving success rates similar to those in the general population. Studies indicate that it generates a strong immune response, crucial for cancer patients who often have weaker immune systems. Meanwhile, the LUNAR-COV19 vaccine, another treatment option in this trial, is a new type of mRNA vaccine that can enhance its own effect, potentially providing a stronger and longer-lasting immune boost than Comirnaty. Early research suggests it might better help the immune system of cancer patients recognize and fight the virus. Both vaccines aim to protect against COVID-19, but LUNAR-COV19 might offer extra protection due to its self-amplifying feature.13678
Who Is on the Research Team?
Joshua Hill, MD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for adult patients who have undergone a hematopoietic cell transplant (HCT). It aims to compare the effectiveness of two COVID-19 vaccines: LUNAR-COV19, a self-amplifying mRNA vaccine, and Comirnaty. Participants should be due for their recommended repeat SARS-CoV-2 vaccination.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either LUNAR-COV19 or Comirnaty vaccine intramuscularly on days 1, 29, and 113
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits on days 115, 120, 127, 141, and 281
What Are the Treatments Tested in This Trial?
Interventions
- Comirnaty
- LUNAR-COV19
Trial Overview
The study is testing whether the LUNAR-COV19 vaccine can induce a stronger immune response compared to the Comirnaty vaccine in HCT recipients. The trial involves administering these vaccines and monitoring through biospecimen collection, health record review, and surveys.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fred Hutchinson Cancer Center
Lead Sponsor
Arcturus Therapeutics, Inc.
Industry Sponsor
Seqirus
Industry Sponsor
Dr. Paul McKenzie
Seqirus
Chief Executive Officer since 2023
PhD in Engineering
Dr. Gregg Sylvester
Seqirus
Chief Health Officer since 2016
MD from Albany Medical College, MPH from Johns Hopkins Bloomberg School of Public Health
Citations
SARS-CoV-2 mRNA vaccines sensitize tumours to immune ...
Immune checkpoint inhibitors (ICIs) extend survival in many patients with cancer but are ineffective in patients without pre-existing ...
Efficacy and safety of the BNT162b2 mRNA COVID-19 ... - PMC
In participants with past or active neoplasms, BNT162b2 vaccine has a similar efficacy and safety profile as in the overall trial population.
3.
pfizer.com
pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-topline-data-demonstratingPfizer and BioNTech Announce Topline Data ...
Pfizer and BioNTech Announce Topline Data Demonstrating Robust Immune Response With Their LP.8.1-Adapted COVID-19 Vaccine 2025-2026 Formula.
Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19 ...
LUNAR-COV19 may be safe and tolerable and may generate a better and more durable immune response than the Comirnaty vaccine in adult patients ...
Real World Evidence | COMIRNATY (COVID-19 Vaccine ...
Select real-world analysis of vaccine effectiveness data associated with the 2024-2025 Formula of COMIRNATY. Observed estimated early vaccine effectiveness (VE).
Workgroup Safety Uncertainties of mRNA COVID Vaccines
IgG4 correlates with poor survival outcomes in PDAC (96 cases). • Axillary Lymphangioma (case report). • Multiple Keratoacanthomas (skin cancer; ...
COVID-19 vaccine safety studies among special populations
Our finding showed that among the reported outcomes, the top four most prevalent severe events were lymphadenopathy, autoimmune disease and MS ...
COVID-19 vaccination, all-cause mortality, and hospitalization ...
The rate of hospitalization for cancer of any site was 0.85% in the unvaccinated group, and 1.15% in the group vaccinated with at least one dose (p<0.001). At ...
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