MedTrace Logo

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

NCT04954287 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-02-07

No results posted yet for this study

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

Interventions

BIOLOGICAL

CVXGA1 low dose

see arm/group description

BIOLOGICAL

CVXGA1 high dose

see arm/group description

Sponsors & Collaborators

  • CyanVac LLC

    lead INDUSTRY

Principal Investigators

  • Paul Spearman, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-06
Primary Completion
2023-06-10
Completion
2023-06-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04954287 on ClinicalTrials.gov