Covid19, SARS-CoV2 Infection
Conditions
Keywords
Immunogenicity, Antibodies, Vaccine Adverse Events
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
Interventions
BIOLOGICALmRNA-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.
Sponsors
ModernaTX, Inc.
H. Lee Moffitt Cancer Center and Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
Countries
United States
Outcome results
None listed