Identifying responders to MUC1 vaccine
Tab Title Description
Describes 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.
- Rochester, Minnesota: 19-005611
Sponsor Protocol Number: CPN1941
About this study
A preventative MUC1 vaccine being tested in a clinical trial MAY13-01-01 in individuals with a history of advanced adenomas and an increased risk for colon cancer, gives 2 different outcomes. About half of vaccinated individuals make a strong anti-MUC1 IgG (vaccine responders) and the other half do not (vaccine non-responders). We have been analyzing differential gene expression in pre-vaccination PBMCs from these two groups to identify a gene expression signature that can predict response. We are now proposing to confirm and extend these studies by doing gene expression analysis at the single cell level rather than total PBMC. This will allow us to better understand the gene expression differences we have already identified by total PBMC RNAseq and to determine if differences we see exist across the board in many cell populations in the PBMC or are limited to just a few cell population(s) that are for some reason expended in one group and not in the other. Since the ultimate goal of acquiring this knowledge is to identify various targets for therapy that would turn everyone into a vaccine responder, the ability to properly interpret the gene expression differences will be very important. Our hypothesis is that a single cell RNAseq analysis of PBMC from 8 responders and 8 non-responders to the MUC1 vaccine, which were already analyzed by RNAseq of total PBMC, will distinguish between the across the board differences in gene expression versus differences in specific (new) cell populations between these two groups. Our Specific Aim is to select frozen PBMC from 8 responders (positive in ELISA for anti-MUC1 IgG at week 12 post-vaccination) and 8 non-responders (negative for anti-MUC1 IgG) and put them through single cell RNA sequencing as described below. Multiple analyses will be performed on the resulting sequences, including specific cell population composition as well as differences in gene expression between these cell populations
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.
Our hypothesis was that looking at differential gene expression in PBMCs of responders versus non-responders pre-vaccination would reveal specific genes or pathways involved in the response. We completed this work under the Correlative Study MAY13-01-01-A02 and discovered over 150 differentially expressed genes and several differentially regulated pathways that could predict who will respond and who will not respond to the vaccine. This work was done using RNAseq analysis on the entire PBMC population. Since PBMCs are a very heterogeneous population of many different cell types, total PBMC RNAseq, while very useful in detecting differentially expressed genes, cannot distinguish between those genes being expressed across the entire population, versus in only one particular cell type that might be different between responders and non-responders. Single cell RNAseq is the newest technique that can provide this information.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Paul Limburg, M.D.
Closed for enrollment
Cancer Center Clinical Trials Referral Office
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available