MumpsPhase 1NCT06967181
A Phase 1 Trial of Intranasal Mumps Virus Vaccines in Healthy Adults
A Phase 1 study testing CVM150 and CVM26 in people with Mumps, run by CyanVac LLC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Mumps
- What is being tested?
- CVM150 and CVM26
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 May 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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*.
- As determined by medical history and physical examination to evaluate acute or ongoing chronic medical diagnoses/conditions that have been present for at least 90 days, which would affect the safety assessment of subjects. Chronic medical diagnoses/conditions should be stable for the last 60 days (no hospitalizations, emergency room (ER), or urgent care for condition or need for supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency due to deterioration of the chronic medical diagnosis/condition in the 60 days before enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or done for financial reasons, and in the same class of medication, will not be considered a deviation of this inclusion criterion.
- Any change in prescription medication due to improvement of a disease outcome, as determined by the participating site principal investigator (PI) or appropriate sub- investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the participating site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity, and do not indicate a worsening of medical diagnosis/condition. Similarly, medication changes subsequent to enrollment and trial vaccination are acceptable provided the change was not precipitated by deterioration in the chronic medical condition, and there is no anticipated additional risk to the subject or interference with the evaluation of responses to trial vaccination.
- Prior receipt of two doses of mumps vaccine in childhood (as MMR or MMRV).
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- 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.
- Male subjects of childbearing potential* must use condoms to ensure effective contraception with a female partner of childbearing potential from vaccination until 90 days after vaccination. Such female partners must also use an acceptable form of primary contraception as described under inclusion criterion #5. 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.
- 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.
Who cannot join
- 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.
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- 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.
- Received or plans to receive an inactivated vaccine within 14 days prior to or after trial vaccine.
- Received or plans to receive a live virus vaccine within 28 days prior to or after trial vaccine.
- Bleeding disorder diagnosed by a healthcare provider (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or bleeding difficulties with intramuscular injections or blood draws.
- Current or previous diagnosis of a significant immunocompromising condition or other immunosuppressive condition.
- Resides with someone who is severely immunocompromised.
- Advanced liver or kidney diseases.
- HIV infection, active Hepatitis B virus infection, history of positive serology for Hepatitis C.
- Received oral, intramuscular, or intravenous systemic immunosuppressants, or immune-modifying drugs for >14 days in total within 6 months prior to administration of trial vaccine (for corticosteroids > / = 20 mg/day of prednisone equivalent).
- History of significant/severe wheeze, respiratory symptoms resulting in hospitalization, or known bronchial hyperreactivity to viruses.
- Received immunoglobulin or blood-derived products, within 3 months prior to trial vaccine dose.
- Received chemotherapy, immunotherapy, or radiation therapy within 6 months prior to trial vaccine dose.
- Trial personnel or an immediate family member or household member of trial personnel.
- Is acutely ill or febrile 72 hours prior to or at vaccine dosing day (fever defined as > / = 38.0°C/100.4°F). Subjects meeting this criterion may be rescheduled within the relevant window periods but may require screening for respiratory pathogen infection.
- Receipt or anticipated receipt of, within 7 days prior to through 28 days after trial vaccination, any intranasal medication including FDA-approved prescription or over-the-counter products or non-FDA-approved alternative medicine products (e.g., Ayurvedic oil or other naturopathic substances).
- Currently smoking or vaping, or history of regular smoking or vaping in the past two years (average of 1 cigarette or equivalent daily).
- Active alcohol use disorder or alcohol abuse or active illicit drug abuse.
- Anticipated use of nasal irrigation (e.g., Neti Pot™) after enrollment through 28 days after trial vaccination.
- Nasal piercing within 30 days prior to trial vaccination or planned 30 days after trial vaccination.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cincinnati Children's Hospital Medical Center Vaccine Research Center
Cincinnati, Ohio, 45229
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
University Of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: A Phase 1 Trial of CVM150 and CVM26 Intranasal Mumps Virus Vaccines in Healthy Adults
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.
Read the 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.
- Conditions
- Mumps
- Being tested
- CVM150, CVM26, Placebo
- Medical subject headings
- Mumps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVM150Biological
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.
CVM26Biological
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.
PlaceboOther
Placebo: 0.9% normal sterile saline (purchased commercially).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: CVM26 |
| Placebo | Placebo comparator | Placebo: 0.9% normal sterile saline (purchased commercially). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Geometric mean fold rise (GMFR) of serum mumps virus (MuV) neutralizing antibodies (nAbs) on Day 15 and/or Day 29
Measured: 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
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
Measured: 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
Proportion of participants with an increase in MuV-specific cell mediated immune responses (CMI) in PBMCs at Day 8, 15 and/or Day 29
Measured: 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
Proportion of participants with an increase in mucosal (nasal and/or saliva) MuV- specific IgA at Day 15 and/or Day 29
Measured: Day 15 and/or Day 29
Assess duration of vaccine virus shedding after vaccination
Assess duration of vaccine virus shedding after vaccination
Measured: Day 1 through Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start14 May 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MumpsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CyanVac LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong Jin, Study chair, CyanVac LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967181
- Sponsor's protocol ID
- CVXMV-003
- Status last verified
- Dec 2025
- First submitted
- 1 May 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of CVM150 and CVM26 Intranasal Mumps Virus Vaccines in Healthy Adults
- ClinicalTrials.gov ID
- NCT06967181
- Acronym / sponsor ID
- CVXMV-003
- Conditions
- Mumps
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CyanVac LLCIndustry (pharma, biotech, devices)
- Study start
- 14 May 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CVM150 | Experimental | Biological: CVM150CVM150: 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. |
| CVM26 | Experimental | Biological: CVM26CVM26: 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. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo: 0.9% normal sterile saline (purchased commercially). |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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*.
- Any change in prescription medication due to improvement of a disease outcome, as determined by the participating site principal investigator (PI) or appropriate sub- investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the participating site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity, and do not indicate a worsening of medical diagnosis/condition. Similarly, medication changes subsequent to enrollment and trial vaccination are acceptable provided the change was not precipitated by deterioration in the chronic medical condition, and there is no anticipated additional risk to the subject or interference with the evaluation of responses to trial vaccination.
- Prior receipt of two doses of mumps vaccine in childhood (as MMR or MMRV).
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVM150CVM150- 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 |
| CVM26CVM26: 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 |
| PlaceboPlacebo: 0.9% normal sterile saline (purchased commercially). | Other | Placebo |
Primary outcome
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)
Time frame: 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)
The percentage of participants who experience any solicited systemic reactogenicity symptom through 7 days postvaccination (Day 1 through Day 8)
Time frame: 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 unsolicited adverse event (AE) through 28 days post-vaccination (Day 1 through Day 29)
Time frame: 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)
The percentage of participants who experience the following events through 6 months post-vaccination: • SAEs • MAAEs • AESIs • NOCMCs
Time frame: Day 1 through Day 181
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)
The percentage of participants who experience the following events through 12 months post-vaccination: • SAEs • MAAEs • AESIs • NOCMCs
Time frame: Day 1 through Day 366
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)
5 secondary outcomes
Geometric mean fold rise (GMFR) of serum mumps virus (MuV) neutralizing antibodies (nAbs) on Day 15 and/or Day 29
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 15 and/or Day 29
Assess duration of vaccine virus shedding after vaccination
Time frame: Day 1 through Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Jin study chair
CyanVac LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CVM150 and CVM26 in people with Mumps, run by CyanVac LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Day 1 through Day 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.