Covid19 Clinical Trial
Official title:
Immunogenicity of a Third Dose of mRNA-1273 Vaccine (Moderna) Among Cancer Patients
Verified date | April 2023 |
Source | H. Lee Moffitt Cancer Center and Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
United States | Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | ModernaTX, Inc. |
United States,
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 |
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