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

Study Overview
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Brief Summary
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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

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

Conditions
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Covid19, SARS-CoV2 Infection

Intervention / Treatment
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* Biological: mRNA-1273


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants who receive 3rd dose of mRNA-1273 SARS-CoV-2 vaccine<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunogenicity, Antibodies, Vaccine Adverse Events