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.
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 malignancy
Current infection with SARS-CoV-2 or infection within the prior 28 day period
Positive for SARS-CoV-2 by nasal swab polymerase chain reaction (PCR) at screening
Currently receiving any approved, authorized, or investigational direct-acting antiviral drug against SARS-CoV-2
Received any approved, authorized, or investigational monoclonal anti-SARS-CoV-2 antibody therapy within the prior 180 days before screening
Parallel
SARS-CoV-2 mRNA Vaccine ARCT-021
Biological/VaccineGiven IM
Tozinameran
Biological/VaccineGiven IM
Biospecimen Collection
Procedure/SurgeryUndergo nasal swab and blood sample collection
Electronic Health Record Review
Other interventionAncillary studies
Survey Administration
Other interventionAncillary studies
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.
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.
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.
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.
nAb GMT against spike protein matching the SARS-CoV-2 variant included in the vaccine
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