Safety and Reactogenicity of a PAL Combined With Seasonal Flu Vaccine in Healthy Adults

NCT02188810 | Unknown Phase 1 DMC

• 1 other identifier: PE1202
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1, research study is looking at the safety and acceptability of a new vaccine adjuvant (immune booster) called PAL when combined with the seasonal flu vaccine (Fluviral) to test the safety and effectiveness of new vaccines and medications on healthy volunteers. The study will enroll approximately 48 healthy adult participants, and occur over 3 years. In the first six months/180 days of the study participants will have visits to the study site during which safety and immunogenicity outcomes will be measured. From Day 181 to Year 3, participants will be contacted by telephone or email to collect information on any adverse events.

Conditions

Flu

Keywords

PAL; fluviral; healthy volunteer; adjuvant; TH1 immune response

Outcome Measures

Primary Outcomes (1)

• Safety

  The occurrence of adverse events from injection to Day 1095 (36 months/three years, in all participants, in all groups:

  3 years

Secondary Outcomes (7)

• Immunogenicity

  6 months

• Immunogenicity of TIV combined with PAL

  6 months

• Immune responses

  6 months

• Induced immune responses

  6 months

• Solicited and General Adverse Events

  up to 6 months

Study Arms (6)

Group 1

ACTIVE COMPARATOR

Single dose of control vaccine (a single dose of 0.5 mL TIV).

Biological: TIV

Group 2

EXPERIMENTAL

Single dose of the test article (0.25 mL TIV, which is 7.5 μg of each influenza strain with 0.5x PAL, i.e. 30 μg).

Biological: PAL; Biological: TIV

Group 3

EXPERIMENTAL

Single dose of the test article (0.25 mL TIV, which is 7.5 μg of each influenza strain with 1x PAL, i.e. 60 μg).

Biological: PAL; Biological: TIV

Group 4

EXPERIMENTAL

Single dose of the test article (0.25 mL of TIV which is 7.5 μg of each influenza strain with 2x PAL (i.e., 120 μg).

Biological: PAL; Biological: TIV

Group 5

EXPERIMENTAL

Single dose of the test article (0.25 mL of TIV which is 7.5 μg of each influenza strain with 4x PAL (i.e., 240 μg).

Biological: PAL; Biological: TIV

Group 6

EXPERIMENTAL

Single dose of the test article (0.125 mL of TIV with 4x PAL i.e., 240 μg).

Biological: PAL; Biological: TIV

Interventions

PAL BIOLOGICAL

Single dose administered intramuscularly.

Also known as: PapMV Adjuvant Long lasting immune response, FB-631

Group 2; Group 3; Group 4; Group 5; Group 6

TIV BIOLOGICAL

Single dose administered intramuscularly .

Also known as: Trivalent Influenza Vaccines, Fluviral

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good general health status, as determined by history and physical examination no greater than 30 days prior to administration of the first test article.
• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of Diary Cards, return for follow-up visits).
• If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection and has a negative pregnancy test on the day of injection and has agreed to continue adequate contraception until 180 days after injection. (Please refer to the glossary for the definition of child-bearing potential and adequate contraception).

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study product within 28 days preceding the dose of study product, or planned use during the study period.
• Planned administration/ administration of a vaccine/product not foreseen by the study protocol within the period starting 28 days before injection and ending 28 days after.
• Planned administration/ administration of the seasonal influenza vaccine recommended by local public health authorities within the period starting 120 days before injection and ending 121 days after. (Note: enrolment should be completed 120 days before the annual seasonal influenza vaccine campaigns in October and December)
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study product or planned administration during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. (Laboratory testing for HIV, Hepatitis C and Hepatitis B will be performed during the screening visit).
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drug within 6 months prior to the product dose
• Family history of congenital or hereditary immunodeficiency.
• History of or current autoimmune disease.
• Known or suspected hypersensitivity to Fluviral, to thimerosal, or to any other ingredient in the formulation or component of the container.
• Pregnant or lactating female.
• Any hematological (hemoglobin level, white blood cell \[WBC\], and platelet count) and biochemical (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], blood urea nitrogen \[BUN\] and creatinine) abnormality as per local laboratory normal values considered clinically significant by the investigator.
• Any acute or chronic, clinically significant disease, as determined by physical examination or laboratory screening tests.
• Any other condition that the investigator judges may interfere with study procedures (e.g. drawing blood) or findings (e.g. immune response).

Sponsors & Collaborators

• Folia Biotech Inc.: lead

Study Sites (1)

Canadian Center for Vaccinology

Halifax, Nova Scotia, B3K 6R8, Canada

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Joanne Langley, M.D.

  Canadian Center for Vaccinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 14, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 12, 2016

Record last verified: 2016-02

Locations

CA (1)