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

NCT05054218 | Completed FDA Drug

• 1 other identifier: MCC-21536
• Study Type: observational
• Target: 336
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19; SARS-CoV2 Infection

Keywords

Immunogenicity; Antibodies; Vaccine Adverse Events

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Solicited local and systemic adverse reactions (ARs) post-dose 3 up to study day 20

  Up to 20 days

• Solicited local and systemic adverse reactions (ARs) post-dose 3 up to study day 40

  Up to 42 days

• Number of participants who experienced Serious Adverse Events and Adverse Events

  Baseline thru up to 6 months

Study Arms (1)

Participants who receive 3rd dose of mRNA-1273 SARS-CoV-2 vaccine

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

Interventions

mRNA-1273 BIOLOGICAL

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.

Participants who receive 3rd dose of mRNA-1273 SARS-CoV-2 vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of Moffitt Cancer Center who have completed their two-dose series of the mRNA-1273 vaccine prior to March 31, 2021.

You may qualify if:

• 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

You may not qualify if:

• Participants who will not return for the third vaccine dose

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• ModernaTX, Inc.: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trial Search

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Draw: One (1) 10 ml tiger-top tube Blood Draw: Two (2) 8 ml CPT tubes

MeSH Terms

Conditions

COVID-19

Interventions

2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Anna Giuliano, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 23, 2021
• Study Start: September 10, 2021
• Primary Completion: July 16, 2022
• Study Completion: August 29, 2022
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

US (1)