A Phase 2 Trial of the Immunogenicity and Safety of CVXGA Intranasal COVID Vaccine in Healthy Adults

NCT05736835 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CVXGA-002
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

COVID-19

Keywords

COVID-19; intranasal vaccine

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  day 15 and day 29

Secondary Outcomes (2)

• Secondary Safety

  day 1 to 6 months

• Secondary Immunogenicity

  day 15 and day 29

Study Arms (2)

CVXGA

EXPERIMENTAL

CVXGA single intranasal dose 10e7 PFU

Biological: CVXGA

Placebo

PLACEBO COMPARATOR

0.9% sterile saline

Biological: CVXGA

Interventions

CVXGA BIOLOGICAL

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.

Also known as: PIV5-SARS CoV-2

CVXGA; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 \[an RSV vaccine being developed by Blue Lake Biotechnology\]).
• 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.

Sponsors & Collaborators

• CyanVac LLC: lead

Study Sites (10)

Velocity Clinical Research

San Diego, California, 91942, United States

Location

Velocity Clinical Research

Boise, Idaho, 83642, United States

Location

Velocity Clinical Research

Sioux City, Iowa, 51106, United States

Location

Velocity Clinical Research

Rockville, Maryland, 20854, United States

Location

Velocity Clinical Research

Omaha, Nebraska, 68134, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Velocity Clinical Research

Vestal, New York, 13850, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Velocity Clinical Research

Providence, Rhode Island, 02818, United States

Location

Velocity Clinical Research

Cedar Park, Texas, 78759, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hong Jin

  CyanVac LLC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: February 21, 2023
• Study Start: June 30, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)