Mumps Virus Vaccines for Mumps

Recruiting at 2 trial locations

Overseen By Henry Radziewicz, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: CyanVac LLC

Must not be taking: Immunosuppressants, Immunotherapy

Disqualifiers: Mumps vaccination, COVID-19, Influenza, others

Compensation: Varies

Number of Visits: 7

Duration: 1 day

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this trial is to evaluate the safety and immunogenicity of CVM150 and CVM26. The trial will enroll up to 60 healthy participants.

Research Team

Hong Jin

Principal Investigator

CyanVac LLC

Eligibility Criteria

This trial is for up to 60 healthy adults. Specific eligibility criteria are not provided, but typically participants should have no underlying health conditions that could affect the outcome of the vaccine study.

Inclusion Criteria

I am using or willing to use birth control or practice abstinence.

Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other trial procedures

Determined by medical history, complete physical examination, and clinical judgement of the investigator to be in good state of health

Exclusion Criteria

I have not had COVID-19 in the last 30 days.

I have previously received a PIV5-based or investigational mumps vaccine.

I have been vaccinated for mumps in the last 10 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intranasal dose of CVM150, CVM26, or placebo on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, including local and systemic reactogenicity, immune response, and adverse events

6 months

Approximately 6-7 visits (in-person)

Treatment Details

Interventions

• CVM150
• CVM26

Trial Overview The trial is testing two intranasal mumps virus vaccines: CVM150 and CVM26, against a placebo. The goal is to assess their safety and how well they stimulate the body's immune response (immunogenicity).

Participant Groups

Group I: CVM26 Experimental Treatment 1 Intervention

CVM26: A live, attenuated MuV vaccine based on Iowa strain genetically edited to remove the V and SH protein expression. Formulated in 1x sucrose phosphate glutamate (\[SPG\]; sucrose, KH2PO4, K2HPO4 and L-glutamic acid) buffer.

Group II: CVM150 Experimental Treatment 1 Intervention

CVM150: Live PIV5-based MuV vaccine expressing the MuV (Iowa strain/2006) F and HN proteins formulated in 1x sucrose phosphate glutamate (\[SPG\]; sucrose, KH2PO4, K2HPO4 and L-glutamic acid) buffer.

Group III: Placebo Placebo Group 1 Intervention

Placebo: 0.9% normal sterile saline (purchased commercially).

Who Is Running the Clinical Trial?

CyanVac LLC

Lead Sponsor

Trials

3

Recruited

10,300+