Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    cvxga1
Previous Study | Return to List | Next Study

Phase 1 Study of Intranasal PIV5-vectored COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults (CVXGA1-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04954287
Recruitment Status : Recruiting
First Posted : July 8, 2021
Last Update Posted : February 17, 2022
Sponsor:
Information provided by (Responsible Party):
CyanVac LLC

Brief Summary:
This Phase 1 trial is an open-label trial to evaluate the safety, reactogenicity and immunogenicity of two dosages (10^6 PFU and 10^7 PFU) of intranasal CVXGA1 administered as a single dose in healthy adults age 18-55 years with or without prior receipt of COVID vaccine.

Condition or disease Intervention/treatment Phase
Covid19 Biological: CVXGA1 low dose Biological: CVXGA1 high dose Phase 1

Detailed Description:
This will be an open-label, dose-ranging phase 1 trial of the PIV5 virus-vectored SARS CoV-2 S glycoprotein vaccine (CVXGA1) in healthy adults (males and nonpregnant females) 18 to 55 years of age (Groups 1 and 2) that have not had a prior COVID vaccination or infection, and in healthy adults 18 to 55 years of age (Group 3) who have received a primary regimen of COVID vaccine (Pfizer, Comirnaty®) at least 5 months prior. The trial is designed to assess the safety, reactogenicity, and immunogenicity of a single dose of intranasal CVXGA1. Two dose levels will be assessed, CVXGA1-low lose (LD) at 10^6 plaque- forming units (PFU) (Group 1) and CVXGA1-high lose (HD) 10^7 PFU (Groups 2 and 3). The first 4 subjects in each group will be enrolled as sentinels and vaccination will proceed in a staged fashion.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open-Label, Dose-Ranging Trial to Evaluate the Safety and Immunogenicity of Intranasal Parainfluenza Virus Type 5-SARS-CoV-2 S Vaccine (CVXGA1) in Healthy Adults Aged 18 to 55 Years
Actual Study Start Date : August 6, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Young adult cohort (age 18-55), low dose, no prior COVID vaccine or infection
CVXGA1 administered as a single dose of 1 x 10^6 PFU by intranasal route on Day 1
Biological: CVXGA1 low dose
see arm/group description
Other Name: PIV5-SARS CoV-2 vaccine

Experimental: Young adult cohort (age 18-55), high dose, no prior COVID vaccine or infection
CVXGA1 administered as a single dose of 1 x 10^7 PFU by intranasal route on Day 1
Biological: CVXGA1 high dose
see arm/group description
Other Name: PIV5-SARS CoV-2 vaccine

Experimental: Young adult cohort (age 18-55), high dose, receipt of prior COVID Pfizer vaccine
CVXGA1 administered as a single dose of 1 x 10^7 PFU by intranasal route on Day 1, Pfizer Comirnaty® primary two dose regimen
Biological: CVXGA1 high dose
see arm/group description
Other Name: PIV5-SARS CoV-2 vaccine




Primary Outcome Measures :
  1. Solicited Adverse Events [ Time Frame: Day 1-8 ]
    Frequencies and grades of solicited local and systemic AEs during a 7-day period after dosing

  2. Unsolicited Adverse Events [ Time Frame: Day 1-29 ]
    Frequencies and grades of unsolicited AEs during the 28-day period after dosing


Secondary Outcome Measures :
  1. Serum IgG titers to SARS-CoV-2 S protein [ Time Frame: Day 29 ]
    Geometric mean titer (GMT) of serum IgG titers specific to SARS-CoV-2 spike protein (S)

  2. Percentage of subjects who seroconverted [ Time Frame: Day 29 ]
    Percentage of subjects who seroconverted, where seroconversion is defined as a ≥4-fold increase in titer from Baseline (Day 1) of serum IgG titers specific to SARS-CoV-2 spike protein (S)

  3. Change in IgG titers to SARS-CoV-2 S protein [ Time Frame: Day 29 ]
    Geometric mean fold rise in titer from Baseline (GMFR) of serum IgG titers specific to SARS-CoV-2 spike protein (S)

  4. Adverse Events within 30 min of dosing [ Time Frame: Day 1 ]
    Frequencies of AEs occurring within 30 minutes after dosing

  5. Medically Attended Adverse Events [ Time Frame: Day 1 - 181 ]
    Frequencies of Medically Attended Adverse Events (MAAEs) from Day 1 to Day 181

  6. Serious adverse events, new-onset chronic medical conditions, and adverse events of special interest [ Time Frame: Day 1 to Day 366 ]
    Frequencies of serious adverse events (SAEs), new-onset chronic medical condition (NOCMCs) and AEs of Special Interest (AESIs)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provide informed consent prior to initiation of any trial procedures.
  • Be able to understand and agrees to comply with planned trial procedures and be available for all trial visits.
  • Agrees to the collection of venous blood per protocol.
  • Healthy male or non-pregnant female, between 18 and 55 years of age, inclusive at time of enrollment who are at lower risk of SARS-CoV-2 infection, defined as adults whose health status, profession, locations or circumstances put them at lower risk of exposure to SARS-CoV-2 and COVID-19.
  • Body Mass Index (BMI) <40.0 kg/m2 (or < 35.0 kg/m2 if obesity-related health conditions are present) at screening.
  • 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).
  • Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to vaccination.
  • Male subjects of childbearing potential*: use of condoms to ensure effective contraception with a female partner of childbearing potential from vaccination until 90 days after vaccination. If barrier methods are to be used, then double barrier methods of protection are required i.e. male condom with a cap, diaphragm or sponge with spermicide.
  • 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.
  • In good health.
  • Oral temperature of 97.0°F (36.1°C) to less than 100.4° Fahrenheit (37.8° C).
  • Pulse is less than 100 beats per minute.
  • Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive.
  • Diastolic blood pressure <90 mmHg, inclusive. Repeat blood pressure measurements are permitted.
  • Clinical screening laboratory evaluations (white blood cells (WBC) [total and differential counts], hemoglobin, platelets, alanine transaminase, aspartate transaminase, creatinine, alkaline phosphatase, total bilirubin, lipase, prothrombin time and partial thromboplastin time) are within acceptable normal reference ranges at the clinical laboratory being used. Alternatively, the clinical laboratory abnormalities grading scale noted in the FDA Toxicity Grading Scale for Healthy Adult Volunteers enrolled in Preventive Vaccine Clinical Trials may be used.
  • Must agree to have samples stored for secondary research.
  • Agrees to adhere to pandemic public health guidance on preventing SARS-CoV-2 infection (e.g. wearing a mask, keeping physically distant, sheltering-in) throughout trial duration.
  • Must agree to refrain from donating blood or plasma during the trial (outside of this trial).
  • Seronegative to SARS-CoV-2, for subjects in Group 1, 2, and negative for SARS-CoV-2 by PCR at screening for all Groups.
  • For Group 3 only, documented receipt of Pfizer COVID vaccine primary 2 dose regimen with last dose at least 5 months prior to enrollment, and with no prior or planned receipt of any other COVID-19 vaccine doses or known COVID-19 infection following primary regimen.

Exclusion Criteria:

  • Positive pregnancy test either at screening or just prior to vaccine administration.
  • Female subject who is breastfeeding or plans to breastfeed from the time of the vaccination through 60 days after vaccination.
  • Anyone at high risk of severe COVID-19 disease as per current CDC guidance (< https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html>) or has any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes trial participation.
  • Presence of self-reported or medically documented significant medical or psychiatric condition(s).
  • Has an acute illness, as determined by the participating site PI or appropriate sub-investigator, with or without fever [oral temperature ≥ 38.0° Celsius (100.4° Fahrenheit)] within 72 hours of vaccination.
  • Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening.
  • Has participated in another investigational trial involving any investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) within 60 days, or 5 half-lives, whichever is longer, before vaccine administration.
  • Currently enrolled in or plans to participate in another clinical trial with an investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) that will be received during the trial-reporting period.
  • Has previously participated in an investigational trial of prophylaxis or treatment for SARS-CoV-2 infection or COVID-19 disease.
  • Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines.
  • Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness
  • Anticipating the need for immunosuppressive treatment within the next 6 months.
  • Received immunoglobulins and/or any blood or blood products within the 4 months before vaccine administration or at any time during the trial.
  • Has any blood dyscrasias or significant disorder of coagulation.
  • Has any chronic liver disease, including fatty liver.
  • Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before vaccine administration.
  • Received or plans to receive a licensed, live vaccine within 4 weeks before or after vaccination.
  • Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after vaccination.
  • Receipt or planned receipt during the study period of a COVID-19 vaccine (except for prior doses of the Pfizer COVID vaccine (Comirnaty®) in subjects enrolled in Group 3).
  • Close contact of anyone known to have SARS-CoV-2 infection within 14 days prior to vaccine administration.
  • History of COVID-19 diagnosis (positive test for antigen or PCR or antibody).
  • On current treatment with investigational agents for prophylaxis of COVID-19.
  • Plan to travel outside the United States (US) (continental US, Hawaii, and Alaska) from enrollment through 28 days after vaccination.
  • Reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care.
  • Non-ambulatory.
  • For subjects of any age, individuals currently working with high risk of exposure to SARS-CoV-2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04954287


Contacts
Layout table for location contacts
Contact: Marinka Tellier (706) 201-7798 mtellier@cyanvacllc.com
Contact: Samuel Wu, MD PhD swu@cyanvacllc.com

Locations
Layout table for location information
United States, Kentucky
Kentucky Pediatric/ Adult Research Recruiting
Bardstown, Kentucky, United States, 40004
Contact: Marty Osbourn, RN    502-349-1569    marty@kpar.us   
Contact: Daniel Finn, MD         
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Kari Steinmetz    585-273-2083    kari_steinmetz@urmc.rochester.edu   
Contact: Angela Branche, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Paul Spearman, MD    513-636-4509    paul.spearman@cchmc.org   
United States, Texas
Research Your Health Recruiting
Plano, Texas, United States, 75093
Contact: Waseem Chughtai, MD    972-999-1155    waseem@researchyourhealth.com   
Sponsors and Collaborators
CyanVac LLC
Investigators
Layout table for investigator information
Principal Investigator: Paul Spearman, MD Children's Hospital Medical Center, Cincinnati
Layout table for additonal information
Responsible Party: CyanVac LLC
ClinicalTrials.gov Identifier: NCT04954287    
Other Study ID Numbers: CVXGA1-001
First Posted: July 8, 2021    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified IPD underlying the results reported in any published articles (text, tables, figures, appendices) will be shared.
Supporting Materials: Study Protocol
Time Frame: 5 years, beginning as soon as possible (but no later than 12 months) after article publication
Access Criteria: Data will be made available to investigators and institutions upon request. Requests should be directed to the CyanVac authors of the publication(s).

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CyanVac LLC:
Intranasal Vaccine
COVID-19
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs