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

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05054218
• Collaborator: ModernaTX, Inc. (Industry)
• Enrollment: 336
• Location: 1
• Anticipated Duration (Months): 26.7
• Patients Per Site Per Month: 12.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Covid19; SARS-CoV2 Infection	Biological: mRNA-1273

Study Design

• Study Type: Observational
• Actual Enrollment: 336 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Immunogenicity of a Third Dose of mRNA-1273 Vaccine (Moderna) Among Cancer Patients
• Actual Study Start Date: Sep 10, 2021
• Actual Primary Completion Date: Jun 16, 2022
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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; 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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

Secondary Outcome Measures

1. 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

2. 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

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moffitt Cancer Center	Tampa	Florida	United States	33612

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Anna Giuliano, PhD, Moffitt Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Moffitt Cancer Center Clinical Trial Search

Publications

None provided.

• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• ClinicalTrials.gov Identifier: NCT05054218
• Other Study ID Numbers: MCC-21536
• First Posted: Sep 23, 2021
• Last Update Posted: Jun 22, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by H. Lee Moffitt Cancer Center and Research Institute: Immunogenicity; Antibodies; Vaccine Adverse Events
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Jun 22, 2022