Development of Potential COVID-19 Vaccine and Serological Assay
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-003378
Sponsor Protocol Number: 20-003378
About this study
Our group has explored the use of genomic RNA/phage display libraries derived from primary human malignant melanoma cells as a means of identifying antibody detectable targets on cancer cells (cancer vaccines or antibody guided therapeutics). In this approach, we isolate and affinity-column immobilize the IgG fraction from patient serum before and after immune therapy for melanoma, and expose the immobilized antibodies to bacteriophage expressing approximately 2x109 overlapping cDNA sequences of paired (same patient derived plasma and cancer cells) melanoma genomic RNA. Phage, expressing melanoma cDNA express the proteins/peptides on their capsid are “recognized” by the immobilized antibodies are retained in the column, and subsequently eluted for DNA sequencing. Comparison of the DNA profiles of the eluted phage using pre-immunotherapy and post-immunotherapy patient sera will reveal emergence of new antibodies (post-immunotherapy gain of antibodies) against proteins of potential interest for melanoma targeting. In the current proposal, we hypothesize that reacting COVID serum from patients that have recovered from COVID infection and compare to non-infected self-serum (if available) and control healthy volunteer serum (available in our lab) may identify protein targets that have developed as a result of the COVID infection and could be useful in the development of a COVID vaccine as well as a serologic test for anti-COVID immunity.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria - COVID Patient:
- Adults, age ≥ 18 years old.
- Confirmed history of COVID-19 viral infection.
- Now clinically recovered.
- COVID-19 negative on re-testing or if COVID test is not available, must be symptom-free for 2 weeks.
Exclusion Criteria - COVID Patient:
- Post-recovery COVID-19 virus testing remains positive.
Inclusion Criteria - Healthy Volunteer:
- Otherwise healthy adults (age ≥ 18).
- Not acutely ill.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available