This study evaluates the immunogenicity of a third dose of mRNA-1273 COVID-19 vaccine made by Moderna among cancer patients. Vaccines prepare the immune system to fight infection and prevent illness. Certain cells of the immune system produce antibodies (special proteins) that recognize viruses and prevent them from causing sickness. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus responsible for the COVID-19 infection. The Moderna mRNA-1273 vaccine is intended to boost the immune system to produce antibodies against the SARS-CoV-2. These antibodies may prevent patients from getting sick with the COVID-19 , after exposure to the SARS-CoV-2 virus.
Additional locations may be listed on ClinicalTrials.gov for NCT05054218.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate immunogenicity among cancer patients to a third dose of 100 ug elasomeran (mRNA-1273) 28 days and 6 months post vaccination.
SECONDARY OBJECTIVE:
I. To evaluate the safety of a third dose of 100 ug mRNA-1273 administered to cancer patients up to 6 months post-third vaccine dose.
EXPLORATORY OBJECTIVE:
I. In a study sub-population, to characterize the T cell response pre and post receipt of a third 100 ug mRNA-1273 vaccine dose.
OUTLINE:
Patients receive elasomeran intramuscularly (IM) on day 1 of the study. Patients also undergo collection of blood samples prior to receiving the vaccination on day 1, and at 1 and 6 months post vaccination.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorAnna R Giuliano