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NOT YET RECRUITING
NCT07390968
PHASE2

Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Patients

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

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.

Official title: A Phase 2, Multicenter, Double-Blind, Randomized, Controlled Trial of the Safety and Immunogenicity of a Self-Amplifying mRNA COVID-19 Vaccine in Adult Hematopoietic Cell Transplant Recipients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2026-09-01

Completion Date

2029-01-01

Last Updated

2026-02-09

Healthy Volunteers

No

Interventions

BIOLOGICAL

SARS-CoV-2 mRNA Vaccine ARCT-021

Given IM

BIOLOGICAL

Tozinameran

Given IM

PROCEDURE

Biospecimen Collection

Undergo nasal swab and blood sample collection

OTHER

Electronic Health Record Review

Ancillary studies

OTHER

Survey Administration

Ancillary studies

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States