Phase 1 Study of Intranasal PIV5 COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults and Adolescents

NCT04954287 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CVXGA1-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

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.

Conditions

Covid19

Keywords

Intranasal Vaccine; COVID-19

Outcome Measures

Primary Outcomes (2)

• Solicited Adverse Events

  Frequencies and grades of solicited local and systemic AEs during a 7-day period after dosing

  Day 1-8

• Unsolicited Adverse Events

  Frequencies and grades of unsolicited AEs during the 28-day period after dosing

  Day 1-29

Secondary Outcomes (6)

• Serum IgG titers to SARS-CoV-2 S protein

  Day 29

• Percentage of subjects who seroconverted

  Day 29

• Change in IgG titers to SARS-CoV-2 S protein

  Day 29

• Adverse Events within 30 min of dosing

  Day 1

• Medically Attended Adverse Events

  Day 1 - 181

Study Arms (4)

Group 1, 1 x 10^6 PFU CVXGA1 in Ages 18-55

EXPERIMENTAL

Group 1 (Young adults aged 18 to 55 years - CVXGA1- Low Dose, no prior COVID vaccine or infection)

Biological: CVXGA1 low dose

Group 2, 1 x 10^7 PFU CVXGA1 in Ages 18-55

EXPERIMENTAL

Group 2 (Young adults aged 18 to 55 years - CVXGA1- High Dose, no prior COVID vaccine, no prior COVID vaccine or infection allowed if occurring at least 5 months prior to enrollment)

Biological: CVXGA1 high dose

Group 3, 1 x 10^7 PFU CVXGA1 in Ages 18-55

EXPERIMENTAL

Group 3 (Young adults aged 18-55 years - CVXGA1 - High Dose, prior receipt of two or more doses of COVID mRNA vaccine (Pfizer Comirnaty® or Moderna Spikevax™) at least 5 months prior to study enrollment. Prior COVID infection allowed if occurring at least 5 months prior to study enrollment).

Biological: CVXGA1 high dose

Group 4, 1 x 10^7 PFU CVXGA1 in Ages 12-17

EXPERIMENTAL

Group 4 (Adolescents aged 12-17 years - CVXGA1 - High Dose, prior receipt of two or more doses of COVID mRNA vaccine (Pfizer Comirnaty® or Moderna Spikevax™) at least 5 months prior to study enrollment. Prior COVID infection allowed if occuring at least 5 months prior to study enrollment.

Biological: CVXGA1 high dose

Interventions

CVXGA1 low dose BIOLOGICAL

see arm/group description

Also known as: PIV5-SARS CoV-2 vaccine

Group 1, 1 x 10^6 PFU CVXGA1 in Ages 18-55

CVXGA1 high dose BIOLOGICAL

see arm/group description

Also known as: PIV5-SARS CoV-2 vaccine

Group 2, 1 x 10^7 PFU CVXGA1 in Ages 18-55; Group 3, 1 x 10^7 PFU CVXGA1 in Ages 18-55; Group 4, 1 x 10^7 PFU CVXGA1 in Ages 12-17

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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-19.
• 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.
• 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 mmHg, inclusive.
• Diastolic blood pressure \<95 mmHg, inclusive. Repeat blood pressure measurements are permitted.

Sponsors & Collaborators

• CyanVac LLC: lead

Study Sites (4)

Kentucky Pediatric/ Adult Research

Bardstown, Kentucky, 40004, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Research Your Health

Plano, Texas, 75093, United States

Location

Related Publications (1)

• Nakahashi-Ouchida R, Fujihashi K, Kurashima Y, Yuki Y, Kiyono H. Nasal vaccines: solutions for respiratory infectious diseases. Trends Mol Med. 2023 Feb;29(2):124-140. doi: 10.1016/j.molmed.2022.10.009. Epub 2022 Nov 23.

  PMID: 36435633 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

CVXGA1 COVID-19 vaccine

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

• Paul Spearman, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Progression will be by dose escalation (low dose to high dose) in healthy adults aged 18 to 55 years (N=up to 60), with approximately 12 months' follow-up. Safety data from sentinel subjects (4) will be assessed by a safety monitoring committee (SMC) if halting rules are met for 1) vaccine administration to the remaining subjects within the group, 2) progression from the low dose (1 x 106 PFU) group to the high dose (1 x 107 PFU) groups (without or with prior receipt of COVID vaccine), and 3) progression from the high dose adult group (18 to 55 years) with prior receipt of COVID vaccine to the adolescent (12-17 years) group (N= up to 20) with prior receipt of COVID-19 vaccine.

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 8, 2021
• Study Start: August 6, 2021
• Primary Completion: June 10, 2023
• Study Completion: June 10, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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).

Locations

US (4)