NCT04954287: CVXGA1-001

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

Completed Phase 1 Last updated 7 February 2024

What this trial tests

Phase 1 trial testing CVXGA1 low dose in Covid19 in 72 participants. Completed in 10 June 2023.

Timeline

6 August 2021

Primary endpoint
10 June 2023

10 June 2023

Quick facts

Lead sponsor	CyanVac LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	6 August 2021
Primary completion	10 June 2023
Estimated completion	10 June 2023
Sites	4 locations across United States

Drugs / interventions tested

• CVXGA1 low dose — full drug profile →
• CVXGA1 high dose — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

CyanVac LLC — full company profile →

Who can join

Adults 18 to 55, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intranasal COVID-19 vaccines: From bench to bed.
   Alu A, Chen L, Lei H, Wei Y, et al · · 2022 · cited 181× · PMID 35085851 · DOI 10.1016/j.ebiom.2022.103841
2. Viral vectored vaccines: design, development, preventive and therapeutic applications in human diseases.
   Wang S, Liang B, Wang W, Li L, et al · · 2023 · cited 124× · PMID 37029123 · DOI 10.1038/s41392-023-01408-5
3. Mucosal Vaccines, Sterilizing Immunity, and the Future of SARS-CoV-2 Virulence.
   Focosi D, Maggi F, Casadevall A. · · 2022 · cited 73× · PMID 35215783 · DOI 10.3390/v14020187
4. Mucosal vaccines for SARS-CoV-2: triumph of hope over experience.
   Pilapitiya D, Wheatley AK, Tan HX. · · 2023 · cited 71× · PMID 37146404 · DOI 10.1016/j.ebiom.2023.104585
5. A Narrative Review of COVID-19 Vaccines.
   Eroglu B, Nuwarda RF, Ramzan I, Kayser V. · · 2021 · cited 38× · PMID 35062723 · DOI 10.3390/vaccines10010062
6. A Review of Non-Invasive Drug Delivery through Respiratory Routes.
   Zhang YB, Xu D, Bai L, Zhou YM, et al · · 2022 · cited 35× · PMID 36145722 · DOI 10.3390/pharmaceutics14091974
7. Oral and intranasal vaccines against SARS-CoV-2: Current progress, prospects, advantages, and challenges.
   Kar S, Devnath P, Emran TB, Tallei TE, et al · · 2022 · cited 34× · PMID 35349752 · DOI 10.1002/iid3.604
8. The Role of Mucoadhesion and Mucopenetration in the Immune Response Induced by Polymer-Based Mucosal Adjuvants.
   Vasquez-Martínez N, Guillen D, Moreno-Mendieta SA, Sanchez S, et al · · 2023 · cited 26× · PMID 37050229 · DOI 10.3390/polym15071615