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Active Not Recruiting PHASE1 INTERVENTIONAL NCT06967181

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Detailed Description

This is a randomized, blinded, placebo-controlled, phase 1 clinical trial to evaluate the safety and immunogenicity of CVM150 and CVM26 in healthy adults who received the recommended 2 doses of mumps vaccine (as measles-mumps-rubella \[MMR\] or MMR -varicella \[MMRV\]) in childhood. Number of Participants: A total of up to 60 participants, aged 18-29 years, are planned to be enrolled. Treatment Assignment: All participants will be randomized to receive a single intranasal dose of CVM150, CVM26 or intranasal saline placebo (1:1:1) on Day 1. Study visits: Participants will be asked to complete approximately 6-8 clinic visits, over a period of approximately 12 months duration per participant.

Interventions

Name: CVM150

Type: BIOLOGICAL

Description: 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.

Name: CVM26

Type: BIOLOGICAL

Description: 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.

Name: Placebo

Type: OTHER

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

Primary Outcomes

Measure: 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)

TimeFrame: Day 1 through Day 8

Description: 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)

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

TimeFrame: Day 1 through Day 8

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

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

TimeFrame: Day 1 through Day 29

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

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

TimeFrame: Day 1 through Day 181

Description: 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)

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

TimeFrame: Day 1 through Day 366

Description: 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)

Trial Information

NCT ID

NCT06967181

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

CyanVac LLC

Last Updated

December 15, 2025