COVID-19Phase 2NCT05736835
A Phase 2 Trial of the Immunogenicity and Safety of CVXGA Intranasal COVID Vaccine in Healthy Adults
A Phase 2 study testing CVXGA in people with COVID-19, run by CyanVac LLC at 10 sites in United States.
Trial summary
The purpose of this trial is to evaluate immunogenicity and safety of CVXGA administered as a single intranasal dose against SARS-CoV-2 S-protein in participants. The trial will enroll up to 400 healthy participants, age 18-80 years. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- CVXGA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- 10 sitesUnited States
- Study dates
- 21 Sep 2023to 16 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals ≥ 18 years and ≤ 80 years of age at the time of consent
- Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures
- Determined by medical history, targeted physical examination and clinical judgement of the investigator to be in stable state of health. Screening laboratory values slightly outside lab normal ranges may be acceptable if the site investigator determines that they are not clinically significant.
- 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 each vaccination.
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- 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 #4. 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.
- Male subjects agree to refrain from sperm donation from the time of vaccination until 90 days after vaccination.
- Female subjects agree to refrain from egg donation from time of vaccination until 90 days after vaccination.
Who cannot join
- Receipt of approved or authorized COVID vaccine < 150 days prior to planned study vaccine administration or planned receipt of COVID vaccine during 6 months following receipt of study vaccine.
- Covid infection (Positive COVID-19 test) < 150 days prior to planned study vaccine administration
- Pregnant or breastfeeding participants.
- History of severe COVID-19 infection (e.g., need for oxygenation or ventilatory support)
- Receipt of SARS-CoV-2 immunoglobulin, monoclonal antibody or plasma antibody therapy < 150 days prior to study vaccine administration
- Any prior receipt of a PIV5-based vaccine (e.g., CVXGA1 or BLB-201 [an RSV vaccine being developed by Blue Lake Biotechnology]).
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- 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 study or receipt of any investigational study product within 28 days prior to study 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 myocarditis or pericarditis at any time prior to enrollment, history of Kawasaki disease, or history of multisystem inflammatory syndrome after COVID infection.
- Received or plans to receive a vaccine within 14 days prior to or after study 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.
- Advanced (CD4 count < 200) and/or untreated HIV, active Hepatitis B virus infection, 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 study 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 study vaccine dose.
- Received chemotherapy, immunotherapy or radiation therapy within 6 months prior to study vaccine dose.
- Study personnel or an immediate family member or household member of study personnel.
- Is acutely ill or febrile 72 hours prior to or at vaccine dosing day (fever defined as > / = 38.0 degrees Celsius /100.4 degrees Fahrenheit). Participants meeting this criterion may be rescheduled within the relevant window periods.
- 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
- 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.
- Diagnosis of dementia or other cognitive deficit that might impact a participant's ability to understand the clinical trial or be compliant with trial procedures.
- Planned hospital admission (e.g., for surgical or other invasive procedures) during the 6 months after trial enrollment that could interfere with study trial visits.
- Planned admission or stay at an assisted living or other care facility during the 6 months after trial enrollment.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Velocity Clinical Research
Boise, Idaho, 83642
Velocity Clinical Research
Cedar Park, Texas, 78759
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Velocity Clinical Research
Omaha, Nebraska, 68134
Velocity Clinical Research
Providence, Rhode Island, 02818
University of Rochester
Rochester, New York, 14642
Velocity Clinical Research
Rockville, Maryland, 20854
Velocity Clinical Research
San Diego, California, 91942
Velocity Clinical Research
Sioux City, Iowa, 51106
Velocity Clinical Research
Vestal, New York, 13850
About this study
The purpose of this trial is to evaluate immunogenicity and safety of CVXGA administered as a single intranasal dose against SARS-CoV-2 S-protein in participants. The trial will enroll up to 400 healthy participants, age 18-80 years.
Read the detailed description
This is a randomized, placebo controlled, blinded study to evaluate the immunogenicity and safety of CVXGA.
Trial Population: Up to 400 healthy adults (18-80 years) that may have had prior COVID vaccination or COVID infection at least 5 months prior to planned study vaccine receipt.
Vaccine: CVXGA is a recombinant parainfluenza virus type 5 (PIV5) that carries the SARS-CoV-2 S protein. The vaccine will be administered as a single intranasal dose as a spray.
Study visits: Participants will be asked to complete 3 clinic visits and 1 follow-up phone call.
Participants >= 65 yrs of age will have an additional 2 clinic visits to test for vaccine shedding.
Follow-up will be for 6 months after single vaccination.
- Conditions
- COVID-19
- Being tested
- CVXGA
- Keywords
- COVID-19, intranasal vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVXGABiological
Also called PIV5-SARS CoV-2
CVXGA is a live viral vector, consisting of a recombinant parainfluenza virus type 5 that carries the SARS-CoV-2 S-protein from WA.1 (not enrolling) or XBB1.5 strain.
| Study group | Role | What they receive |
|---|---|---|
| CVXGA | Experimental | CVXGA single intranasal dose 10e7 PFU Receives: Biological: CVXGA |
| Placebo | Placebo comparator | 0.9% sterile saline Receives: Biological: CVXGA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcome measures (SAEs, AEs, and local and systemic reactogenicity)
Percentage of subjects overall reporting:
Local reactions for up to 7 days following vaccination (Day 1-8); Systemic events for up to 7 days following vaccination (Day 1-8); Adverse events (AEs) from Day 1 to 29; Serious AEs from Day 1 to 181; AESI from day 1 to 181; Comparison of the percentage of subjects reporting the events listed above compared with percentage of subjects in the placebo group
Measured: day 1-8, day 1-29, and day 1-181 post vaccination
Immunogenicity
Proportion of subjects with an increase in GMFR from baseline for serum SARS-CoV-2 S-specific IgG and IgA antibodies (by ELISA) and/or an increase in SARS-CoV-2 S-protein specific cell mediated immune responses (CMI) in PBMC at Day 15 and/or Day 29 from baseline compared to proportion of placebo subjects.
Measured: day 15 and day 29
Secondary outcomes (2)
Secondary Safety
Percentage of subjects reporting MAAEs or NOCMCs from Day 1 to 181 in CVXGA versus placebo group.
Measured: day 1 to 6 months
Secondary Immunogenicity
Proportion of subjects with an increase in nasal SARS-CoV-2 S-specific IgA at Day 15 and/or Day 29 from baseline compared to proportion of placebo subject
Measured: day 15 and day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start21 Sep 2023
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 227 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
- NCT05736835
- Sponsor's protocol ID
- CVXGA-002
- Status last verified
- Jul 2026
- First submitted
- 17 Feb 2023
- Last updated
- 14 Jul 2026
- 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of the Immunogenicity and Safety of CVXGA Intranasal COVID Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT05736835
- Acronym / sponsor ID
- CVXGA-002
- Conditions
- COVID-19
- Keywords
- COVID-19, intranasal vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- CyanVac LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 21 Feb 2023 (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 immunogenicity and safety of CVXGA administered as a single intranasal dose against SARS-CoV-2 S-protein in participants. The trial will enroll up to 400 healthy participants, age 18-80 years.
Detailed description
This is a randomized, placebo controlled, blinded study to evaluate the immunogenicity and safety of CVXGA.
Trial Population: Up to 400 healthy adults (18-80 years) that may have had prior COVID vaccination or COVID infection at least 5 months prior to planned study vaccine receipt.
Vaccine: CVXGA is a recombinant parainfluenza virus type 5 (PIV5) that carries the SARS-CoV-2 S protein. The vaccine will be administered as a single intranasal dose as a spray.
Study visits: Participants will be asked to complete 3 clinic visits and 1 follow-up phone call.
Participants >= 65 yrs of age will have an additional 2 clinic visits to test for vaccine shedding.
Follow-up will be for 6 months after single vaccination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVXGA | Experimental | Biological: CVXGACVXGA single intranasal dose 10e7 PFU |
| Placebo | Placebo comparator | Biological: CVXGA0.9% sterile saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Individuals ≥ 18 years and ≤ 80 years of age at the time of consent
- Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures
- Determined by medical history, targeted physical examination and clinical judgement of the investigator to be in stable state of health. Screening laboratory values slightly outside lab normal ranges may be acceptable if the site investigator determines that they are not clinically significant.
- 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.
Key exclusion criteria (29 listed)
- Receipt of approved or authorized COVID vaccine < 150 days prior to planned study vaccine administration or planned receipt of COVID vaccine during 6 months following receipt of study vaccine.
- Covid infection (Positive COVID-19 test) < 150 days prior to planned study vaccine administration
- Pregnant or breastfeeding participants.
- History of severe COVID-19 infection (e.g., need for oxygenation or ventilatory support)
- Receipt of SARS-CoV-2 immunoglobulin, monoclonal antibody or plasma antibody therapy < 150 days prior to study 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 |
|---|---|---|
| CVXGAAlso: PIV5-SARS CoV-2CVXGA is a live viral vector, consisting of a recombinant parainfluenza virus type 5 that carries the SARS-CoV-2 S-protein from WA.1 (not enrolling) or XBB1.5 strain. | Biological | CVXGA, Placebo |
Primary outcome
Safety outcome measures (SAEs, AEs, and local and systemic reactogenicity)
Time frame: day 1-8, day 1-29, and day 1-181 post vaccination
Percentage of subjects overall reporting: Local reactions for up to 7 days following vaccination (Day 1-8); Systemic events for up to 7 days following vaccination (Day 1-8); Adverse events (AEs) from Day 1 to 29; Serious AEs from Day 1 to 181; AESI from day 1 to 181; Comparison of the percentage of subjects reporting the events listed above compared with percentage of subjects in the placebo group
Immunogenicity
Time frame: day 15 and day 29
Proportion of subjects with an increase in GMFR from baseline for serum SARS-CoV-2 S-specific IgG and IgA antibodies (by ELISA) and/or an increase in SARS-CoV-2 S-protein specific cell mediated immune responses (CMI) in PBMC at Day 15 and/or Day 29 from baseline compared to proportion of placebo subjects.
2 secondary outcomes
Secondary Safety
Time frame: day 1 to 6 months
Secondary Immunogenicity
Time frame: day 15 and day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- 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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CVXGA in people with COVID-19, run by CyanVac LLC at 10 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 9 inclusion and 29 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: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety outcome measures (SAEs, AEs, and local and systemic reactogenicity) (time frame: day 1-8, day 1-29, and day 1-181 post vaccination). The study lists 2 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 14 Jul 2026.