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 and Adolescents Aged 12 to 17 Years
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- CyanVac LLC
- Enrollment
- 72
- Locations
- 4
- Primary Endpoint
- Unsolicited Adverse Events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 and in adolescents age 12-17.
Detailed Description
This is 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 that have not had a prior COVID vaccination (Groups 1 and 2), and in healthy adults 18 to 55 years of age (Groups 3) and adolescents 12-17 years of age (Group 4) who have received at least two doses of mRNA-based COVID vaccines (Pfizer Comirnaty® or Moderna Spikevax™) with the last dose at least 5 months prior to planned receipt of CVXGA1 study vaccine. 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 106 plaque-forming units (PFU) (Group 1) and CVXGA1-high dose (HD) at 107 PFU (Groups 2, 3 and 4).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provide informed consent and assent as applicable 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 12 and 55 years of age inclusive at time of enrollment who are not at high risk of SARS-CoV-2 exposure defined as individuals whose health status, profession, locations or circumstances put them at high risk of exposure to SARS-CoV-2 and COVID-
- •Body Mass Index (BMI) \<40.0 kg/m2 (or \< 35.0 kg/m2 if obesity-related health conditions are present) at screening. Subjects must weigh a minimum of 31 kg.
- •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. \*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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Unsolicited Adverse Events
Time Frame: Day 1-29
Frequencies and grades of unsolicited AEs during the 28-day period after dosing
Solicited Adverse Events
Time Frame: Day 1-8
Frequencies and grades of solicited local and systemic AEs during a 7-day period after dosing
Secondary Outcomes
- Serum IgG titers to SARS-CoV-2 S protein(Day 29)
- Change in IgG titers to SARS-CoV-2 S protein(Day 29)
- Adverse Events within 30 min of dosing(Day 1)
- Serious adverse events, new-onset chronic medical conditions, and adverse events of special interest(Day 1 to Day 366)
- Percentage of subjects who seroconverted(Day 29)
- Medically Attended Adverse Events(Day 1 - 181)