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

Launched by FOLIA BIOTECH INC. · Jul 10, 2014

Keywords

ClinConnect Summary

This is a phase 1, dose-ranging, randomized (5:1), observer-blind, controlled study of the safety and immune response to intramuscular injection of PapMV (Papaya Mosaic Virus) rVLP (Recombinant Virus-Like Particles) which is PAL adjuvant, or "PAL" combined with Trivalent Influenza Vaccines (TIV) at one of four dose levels of PAL, combined with one of two dose levels of TIV, or active control (TIV). The study will enroll approximately 48 healthy adult participants, and occur over 3 years. In the first six months/180 days (Epoch 1) of the study participants will have visits to the study site ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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).
• Exclusion Criteria:
• • 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).