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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05054218
• Other study ID #: MCC-21536
• Status: Completed
• Start date: September 10, 2021
• Est. completion date: August 29, 2022

Study information

• Verified date: April 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: August 29, 2022
• Est. primary completion date: July 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV2 Infection

Intervention

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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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

External Links

•   Moffitt Cancer Center Clinical Trial Search