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

Immunogenicity of a Third Dose of mRNA-1273 Vaccine (Moderna) Among Cancer Patients

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 Overview

• Status: Completed
• Conditions: Covid19; SARS-CoV2 Infection
• Intervention / Treatment: Biological: mRNA-1273

• Study Type: Observational
• Enrollment (Actual): 336

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients of Moffitt Cancer Center who have completed their two-dose series of the mRNA-1273 vaccine prior to March 31, 2021.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants who receive 3rd dose of mRNA-1273 SARS-CoV-2 vaccine; Cancer patients who have already received their 1st and 2nd doses of mRNA-1273 SARS-CoV-2 vaccine will receive a 3rd dose of the vaccine. The volume of vaccine injected will be 0.5 mL, containing a 100-μg dose of mRNA-1273.	Biological: mRNA-1273; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	Baseline thru up to 6 months

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: ModernaTX, Inc.
• Investigators: Principal Investigator: Anna Giuliano, PhD, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trial Search

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): July 16, 2022
• Study Completion (Actual): August 29, 2022

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Immunogenicity; Antibodies; Vaccine Adverse Events
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: MCC-21536

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes