NCT03293732

Study of the Safety, Tolerability and Immunogenicity of an Intranasal Influenza Vaccine Administered to Healthy Adults

Completed Phase 1 Last updated 7 January 2020

What this trial tests

Phase 1 trial testing DCB07010 in Flu, Human in 36 participants. Completed in 30 September 2013.

Timeline

28 November 2012

Primary endpoint
30 March 2013

30 September 2013

Quick facts

Lead sponsor	Advagene Biopharma Co. Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	36
Start date	28 November 2012
Primary completion	30 March 2013
Estimated completion	30 September 2013
Sites	1 location across Taiwan

Drugs / interventions tested

• DCB07010 — full drug profile →
• HA antigens — full drug profile →

Conditions studied

• Flu, Human — all drugs for Flu, Human →

Sponsor

Advagene Biopharma Co. Ltd. — full company profile →

Who can join

Adults 20 to 40, any sex, with Flu, Human. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objectives of this study were to assess the safety and tolerability of DCB07010 when given intranasally at escalating dose levels of 7.5μg, 15μg, 30μg and 45μg, in combination with 22.5μg of influenza HA antigen (7.5μg HA of each of three strains) and to generate sufficient immunogenicity data to enable dose selection for larger and more definitive Phase 2 studies.

This was a single center, double-blind, randomized (2:1), dose-escalation study to assess the safety, tolerability and immunogenicity of 4 different vaccine-adjuvant doses in comparison to influenza HA alone. The 4 treatment cohorts were given DCB07010 in a dose- escalating manner.

Publications & conference data

6 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. Protein-Based Adjuvants for Vaccines as Immunomodulators of the Innate and Adaptive Immune Response: Current Knowledge, Challenges, and Future Opportunities.
   Díaz-Dinamarca DA, Salazar ML, Castillo BN, Manubens A, et al · · 2022 · cited 51× · PMID 36015297 · DOI 10.3390/pharmaceutics14081671
3. Development of Nasal Vaccines and the Associated Challenges.
   Nian X, Zhang J, Zhang J, Huang S, et al · · 2022 · cited 33× · PMID 36297419 · DOI 10.3390/pharmaceutics14101983
4. Nanoplatform Based Intranasal Vaccines: Current Progress and Clinical Challenges.
   Bai Z, Wan D, Lan T, Hong W, et al · · 2024 · cited 14× · PMID 39185745 · DOI 10.1021/acsnano.3c10797
5. A randomized, double-blind, controlled clinical trial to evaluate the safety and immunogenicity of an intranasally administered trivalent inactivated influenza vaccine with adjuvant LTh(αK): A phase I study.
   Pan SC, Hsieh SM, Lin CF, Hsu YS, et al · · 2019 · cited 12× · PMID 30837170 · DOI 10.1016/j.vaccine.2019.02.006
6. Advances and prospects of respiratory mucosal vaccines: mechanisms, technologies, and clinical applications.
   Li J, Wu G, Huang Z, Hu J, et al · · 2025 · cited 5× · PMID 41224752 · DOI 10.1038/s41541-025-01280-0