A Phase 1 Trial of Intranasal Mumps Virus Vaccines in Healthy Adults

NCT06967181 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CVXMV-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Mumps

Outcome Measures

Primary Outcomes (5)

• The percentage of participants who experience any solicited local reactogenicity symptom pertaining to intranasal administration through 7 days post-vaccination (Day 1 through Day 8)

  The percentage of participants who experience any solicited local reactogenicity symptom pertaining to intranasal administration through 7 days post-vaccination (Day 1 through Day 8)

  Day 1 through Day 8

• The percentage of participants who experience any solicited systemic reactogenicity symptom through 7 days postvaccination (Day 1 through Day 8)

  The percentage of participants who experience any solicited systemic reactogenicity symptom through 7 days postvaccination (Day 1 through Day 8)

  Day 1 through Day 8

• The percentage of participants who experience any unsolicited adverse event (AE) through 28 days post-vaccination (Day 1 through Day 29)

  The percentage of participants who experience any unsolicited adverse event (AE) through 28 days post-vaccination (Day 1 through Day 29)

  Day 1 through Day 29

• The percentage of participants who experience the following events through 6 months post-vaccination: • SAEs • MAAEs • AESIs • NOCMCs

  The percentage of participants who experience the following events through 6 months post-vaccination: * serious adverse events (SAEs) * medically attended adverse events (MAAEs) * adverse events of special interest (AESIs) * new onset chronic medical conditions (NOCMCs)

  Day 1 through Day 181

• The percentage of participants who experience the following events through 12 months post-vaccination: • SAEs • MAAEs • AESIs • NOCMCs

  The percentage of participants who experience the following events through 12 months post-vaccination: * serious adverse events (SAEs) * medically attended adverse events (MAAEs) * adverse events of special interest (AESIs) * new onset chronic medical conditions (NOCMCs)

  Day 1 through Day 366

Secondary Outcomes (5)

• Geometric mean fold rise (GMFR) of serum mumps virus (MuV) neutralizing antibodies (nAbs) on Day 15 and/or Day 29

  Day 15 and/or Day 29

• Proportion of participants with an increase in serum MuV-specific immunoglobulin G (IgG) antibodies (by enzyme-linked immunosorbent assay [ELISA]) at Day 15 and/or Day 29

  Day 15 and/or Day 29

• Proportion of participants with an increase in MuV-specific cell mediated immune responses (CMI) in PBMCs at Day 8, 15 and/or Day 29

  Day 8, Day 15 and/or Day 29

• Proportion of participants with an increase in mucosal (nasal and/or saliva) MuV- specific IgA at Day 15 and/or Day 29

  Day 15 and/or Day 29

• Assess duration of vaccine virus shedding after vaccination

  Day 1 through Day 29

Study Arms (3)

CVM150

EXPERIMENTAL

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.

Biological: CVM150

CVM26

EXPERIMENTAL

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.

Biological: CVM26

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

CVM150 BIOLOGICAL

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.

CVM150

CVM26 BIOLOGICAL

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.

CVM26

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals ≥18 years and \<30 years of age at the time of consent.
• 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\*.
• Prior receipt of two doses of mumps vaccine in childhood (as MMR or MMRV).
• Women of childbearing potential\* must agree to use or have practiced true abstinence\*\* or use at least one acceptable primary form of contraception.\*\*\*, \*\*\*\* Note: These criteria are applicable to females in a heterosexual relationship and child-bearing potential (i.e., the criteria do not apply to subjects in a same sex relationship).
• \*Not of childbearing potential: post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure® placement).
• \*\*True abstinence is no sexual intercourse 100% of the time (i.e. male's penis never enters the female's vagina). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post- ovulation methods) and withdrawal are not acceptable methods of contraception.
• \*\*\*Acceptable forms of primary contraception include monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the subject's vaccination, intrauterine devices, birth control pills, and injectable/implantable/insertable hormonal birth control products, condom, or diaphragm with spermicide. If barrier methods are to be used, then double barrier methods of protection are required, i.e. male condom, in combination with a cap, diaphragm, or sponge with spermicide.
• \*\*\*\*Must use at least one acceptable primary form of contraception for at least 28 days prior to vaccination and at least one acceptable primary form of contraception for 90 days after last vaccination. If barrier methods are to be used, then double barrier methods of protection are required, i.e. male condom, in combination with a cap, diaphragm, or sponge with spermicide.
• Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to vaccination.
• \*Biological males who are post-pubertal and considered fertile until permanently sterile by bilateral orchiectomy or vasectomy.
• Female subjects agree to refrain from egg donation from time of vaccination until 90 days after vaccination.
• Male subjects agree to refrain from sperm donation from the time of vaccination until 90 days after vaccination.

You may not qualify if:

• Mumps vaccination within 10 years.
• History of mumps virus infection.
• History of parotitis, epididymoorchitis or oophoritis.
• COVID-19 infection \<30 days prior to planned trial vaccine administration.
• Influenza infection \< 30 days prior to planned trial vaccine administration.
• Pregnant or breastfeeding participants.
• History of severe respiratory infection (e.g., need for oxygenation or ventilatory support).
• Any prior receipt of a PIV5-based vaccine (e.g., CVXGA \[an intranasal COVID-19 vaccine\] or BLB-201 \[an intranasal RSV vaccine\] being developed by CyanVac/Blue Lake Biotechnology).
• Any prior receipt of an investigational mumps vaccine.
• Chronic rhinitis, nasal septal defect causing significant breathing problems, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration.
• Current or planned simultaneous participation in another interventional trial or receipt of any investigational trial product within 28 days prior to trial vaccine administration.
• A history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine (licensed or unlicensed).
• A history of meningitis, encephalitis, facial palsy, Guillain-Barré syndrome, or transverse myelitis.
• Cochlear implants or history of cerebrospinal fluid leak or active communication between the cerebrospinal fluid (CSF) and oropharynx, nasopharynx, nose or ear.
• A history of myocarditis or pericarditis at any time prior to enrollment, history of Kawasaki disease, or history of multisystem inflammatory syndrome after COVID-19 infection.

Sponsors & Collaborators

• CyanVac LLC: lead

Study Sites (3)

University Of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Cincinnati Children's Hospital Medical Center Vaccine Research Center

Cincinnati, Ohio, 45229, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

MeSH Terms

Conditions

Mumps

Condition Hierarchy (Ancestors)

Rubulavirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Hong Jin

  CyanVac LLC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 13, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)