COVID-19 Immunogenicity of a Third Dose of mRNA-1273 Vaccine Among Cancer Patients

H. Lee Moffitt Cancer Center and Research Institute336 enrolled

Overview

Investigators will evaluate the immunogenicity of a third dose of mRNA-1273 SARS-CoV-2 vaccine among cancer patients receiving the recommended third vaccine dose

Study Type

OBSERVATIONAL

Enrollment

336

Conditions

Covid19 SARS-CoV2 Infection

Interventions

mRNA-1273BIOLOGICAL

Participants will receive a 0.5 mL injection of the vaccine that contains a 100-μg dose of mRNA1273. The vaccine will be administered into the deltoid muscle.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least 18 years of age * Is a cancer patient enrolled in the Cancer Patient Immune Response to COVID-19 Vaccine study (a basic science study) MCC 21138 or who has completed the two mRNA-1273 vaccine series prior to March 31, 2021. * Understands, agrees and is able to comply with the study procedures and provides written informed consent. * Has no known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reactions to the vaccine or its excipients. * Has not received more or less than 2 doses of mRNA-1273 vaccine Exclusion Criteria: * Participants who will not return for the third vaccine dose

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

Outcomes

Primary Outcomes

1. The level of anti-SARS-CoV-2 Spike (S)-specific neutralizing antibody (nAb) 28 days post-dose 3

The level of anti-SARS-CoV-2 Spike (S)-specific neutralizing antibody (nAb) up to study day 28 will be measured by specific neutralizing antibody and serum assays

Time frame: 28 days

Anti-SARS-CoV-2 Spike (S)-specific neutralizing antibody (nAb) 6 months post-dose 3

The level of anti-SARS-CoV-2 Spike (S)-specific neutralizing antibody (nAb) up to study month 6 will be measured by specific neutralizing antibody and serum assays

Time frame: 6 months

Anti-SARS-CoV-2 Spike (S)-GMT Ab 28 days post-dose 3

The level of anti-SARS-CoV-2 Spike (S)-GMT Ab up to study day 28 will be measured by specific neutralizing antibody and serum assays

Time frame: 28 days

Anti-SARS-CoV-2 Spike (S)-GMT Ab 6 months post-dose 3

The level of anti-SARS-CoV-2 Spike (S)-GMT Ab up to study month 6 will be measured by specific neutralizing antibody and serum assays

Time frame: 6 months

Level antibodies that block the binding of ACE2 to RBD antigens from 10 SARS-CoV-2 variants of concern 28 days post-dose 3

The level antibodies that block the binding of ACE2 to RBD antigens from 10 SARS-CoV-2 variants of concern up to study day 28 will be measured by specific neutralizing antibody and serum assays

Time frame: 28 days

Level antibodies that block the binding of ACE2 to RBD antigens from 10 SARS-CoV-2 variants of concern 6 months post-dose 3

The level antibodies that block the binding of ACE2 to RBD antigens from 10 SARS-CoV-2 variants of concern up to study month 6 will be measured by specific neutralizing antibody and serum assays

Time frame: 6 months

Data from ClinicalTrials.gov

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Secondary Outcomes

Solicited local and systemic adverse reactions (ARs) post-dose 3 up to study day 20

Investigators will measure solicited local and systemic adverse reactions (ARs) at day 14 (+/- 5 days) post 3rd dose of vaccine

Time frame: Up to 20 days

Solicited local and systemic adverse reactions (ARs) post-dose 3 up to study day 40

Investigators will measure solicited local and systemic adverse reactions (ARs) at day 28 (+ 14 days) post 3rd dose of vaccine

Time frame: Up to 42 days

Number of participants who experienced Serious Adverse Events and Adverse Events

Participants able to safely tolerate a 3rd dose of mRNA-1273 vaccine as measured by adverse events and serious adverse events.

Time frame: Baseline thru up to 6 months