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

Completed

• Conditions: Covid19; SARS-CoV2 Infection
• Interventions: Biological: mRNA-1273

• Registration Number: NCT05054218
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-10
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-14
• Study First Posted: 2021-09-23
• Primary Completion: 2022-07-16
• Study Completion: 2022-08-29
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants who receive 3rd dose of mRNA-1273 SARS-CoV-2 vaccine	mRNA-1273	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.

Primary Outcome Measures

Name	Time	Method
Anti-SARS-CoV-2 Spike (S)-specific neutralizing antibody (nAb) 6 months post-dose 3	6 months	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
Anti-SARS-CoV-2 Spike (S)-GMT Ab 6 months post-dose 3	6 months	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
Level antibodies that block the binding of ACE2 to RBD antigens from 10 SARS-CoV-2 variants of concern 6 months post-dose 3	6 months	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
1. The level of anti-SARS-CoV-2 Spike (S)-specific neutralizing antibody (nAb) 28 days post-dose 3	28 days	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
Level antibodies that block the binding of ACE2 to RBD antigens from 10 SARS-CoV-2 variants of concern 28 days post-dose 3	28 days	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
Anti-SARS-CoV-2 Spike (S)-GMT Ab 28 days post-dose 3	28 days	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

Secondary Outcome Measures

Name	Time	Method
Solicited local and systemic adverse reactions (ARs) post-dose 3 up to study day 20	Up to 20 days	Investigators will measure solicited local and systemic adverse reactions (ARs) at day 14 (+/- 5 days) post 3rd dose of vaccine
Number of participants who experienced Serious Adverse Events and Adverse Events	Baseline thru up to 6 months	Participants able to safely tolerate a 3rd dose of mRNA-1273 vaccine as measured by adverse events and serious adverse events.
Solicited local and systemic adverse reactions (ARs) post-dose 3 up to study day 40	Up to 42 days	Investigators will measure solicited local and systemic adverse reactions (ARs) at day 28 (+ 14 days) post 3rd dose of vaccine

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States