A Phase 2, Double-blind Study to Evaluate Intranasal Trivalent Influenza Virus Vaccine in Healthy Adult

NCT03784885 | Completed Phase 2

• 1 other identifier: 1066021486
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this phase 2 study are to evaluate immunogenicity, safety and tolerability of AD07030, a trivalent influenza virus antigens vaccine, given intranasally in 2 doses in healthy adult volunteers.

Conditions

Influenza Infection

Keywords

adjuvant; vaccine; mucosa; IgA; Escherichia coli Enterotoxin

Outcome Measures

Primary Outcomes (1)

• Geometric mean titer changes on Day 29

  Change from pre- to post-vaccination serum Geometric mean titers (GMT) of hemagglutinin inhibition (HI) antibody at Day 29(±2)

  29 days

Secondary Outcomes (4)

• Immunogenicity (HI titers)

  29, 90 and 180 days

• Immunogenicity (IgA titers)

  29, 90 and 180 days

• Immunogenicity (anti-LTh(αK) antibodies)

  29, 90 and 180 days

• Viral neutralization

  29, 90 and 180 days

Study Arms (3)

30 μg of AD07010

EXPERIMENTAL

All subjects in this group received 2 doses of 22.2 μg HA antigens from inactivated trivalent influenza vaccine in 30 μg of AD07010

Biological: AD07010; Biological: Inactivated trivalent influenza vaccine

45 μg of AD07010

EXPERIMENTAL

All subjects in this group received 2 doses of 22.2 μg HA antigens from inactivated trivalent influenza vaccine in 45 μg of AD07010

Biological: AD07010; Biological: Inactivated trivalent influenza vaccine

AD07010

ACTIVE COMPARATOR

All subjects in this group received 2 doses of 22.2 μg HA antigens from inactivated trivalent influenza vaccine

Biological: Inactivated trivalent influenza vaccine

Interventions

AD07010 BIOLOGICAL

A protein based adjuvant

Also known as: LTh(αK), Escherichia coli heat-labile enterotoxin

30 μg of AD07010; 45 μg of AD07010

Inactivated trivalent influenza vaccine BIOLOGICAL

Inactivated trivalent seasonal influenza vaccine

30 μg of AD07010; 45 μg of AD07010; AD07010

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female subjects aged between 20-70 (included) years.
• Should be physically and mentally healthy and free of significant medical condition as determined by Medical history, Physical examination and Clinical judgment of the Investigator.
• Negative urine β-human chorionic gonadotropin in women of childbearing potential (WOCBP; defined as women ≤ 50 years old of age or history of amenorrhea for ≤12 months) prior to administration of first dose of Investigational Product.
• WOCBP and male subjects having female partners, who are WOCBP, should be protected by effective contraceptive method (e.g. oral contraceptive and condom, intra- uterine device and condom, diaphragm with spermicide and condom) throughout the study period.
• Willing and able to give written informed consent prior to Screening and comply with study procedure.

You may not qualify if:

• Received vaccination against influenza within 6 months prior to Screening.
• Received any vaccination (other than influenza) within 28 days prior to Screening.
• Has previously experienced anaphylaxis or a life-threatening reaction; or has history of allergy or hypersensitivity to egg proteins, chicken proteins, any of the components of Investigational Product, or other vaccine containing same substances.
• History of influenza infection (confirmed either clinically, serologically or microbiologically) within the 6 months prior to administration of first dose of Investigational Product.
• Had active allergic rhinitis within 28 days prior to administration of first dose of Investigational Product.
• Has documented history of diarrhea within 28 days prior to administration of first dose of Investigational Product.
• Have used or been administered any intranasal medication or nasal topical treatment within 7 days prior to Screening.
• Acute respiratory illness within 7 days prior to administration of first dose of Investigational Product.
• Had administration of systemic antibiotics or antivirals within 7 days prior to Screening (excluding topical/external use of antibiotics).
• Acute sinusitis or chronic sinusitis accompanying acute symptoms within 3 days prior to administration of first dose of Investigational Product.
• With acute disease (defined as fever with body temperature \>38.0°C), within 3 days prior to administration of first dose of Investigational Product.
• Having any serious chronic illness, including but not limited to, cardiovascular, pulmonary, hepatic, metabolic, renal or any auto-immune disorders, at a stage that could interfere with trial conduct or completion.
• Any confirmed or suspected immunosuppressive or immune-deficient condition, based on medical history and physical examination.
• Documented history of Bell's palsy or neurological disorder.
• Receive aspirin (Salicylate) anytime in the study from screening (Visit 1)

Sponsors & Collaborators

• Advagene Biopharma Co. Ltd.: lead

Study Sites (1)

Advagene Biopharma

Taipei, 104, Taiwan

Location

Related Publications (1)

• Pan SC, Hsu WT, Lee WS, Wang NC, Chen TJ, Liu MC, Pai HC, Hsu YS, Chang M, Hsieh SM. A double-blind, randomized controlled trial to evaluate the safety and immunogenicity of an intranasally administered trivalent inactivated influenza vaccine with the adjuvant LTh(alphaK): A phase II study. Vaccine. 2020 Jan 29;38(5):1048-1056. doi: 10.1016/j.vaccine.2019.11.047. Epub 2019 Dec 4.

  PMID: 31812463 DERIVED

MeSH Terms

Interventions

heat-labile enterotoxin, E coli

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: September 1, 2017
• Primary Completion: January 7, 2018
• Study Completion: October 30, 2018
• Last Updated: December 26, 2018

Record last verified: 2018-12

Locations

TW (1)