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

Flu Clinical Trial

Official title: A Phase I Randomized, Observer-blind, Controlled, Dose Escalation Trial of the Safety and Tolerability of a Single Intramuscular Dose of a PAL Adjuvant (FB-631) Co-administered With Seasonal TIV (2013-2014) in Healthy Adults.

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

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 during which safety and immunogenicity outcomes will be measured. In Epoch 2 (Day 181 to Year 3) participants will be contacted by telephone or email to collect unsolicited adverse events.

This is a controlled clinical trial. The control group will receive the standard dose of TIV, 0.5 mL, which consists of 15 μg haemagglutinin (HA) of each influenza strain recommended by the World Health Organization (WHO) for the 2013-2014 influenza season in the northern hemisphere. An active control is used so that the attributable risk of adverse events can be estimated, and so that outcome measures can be assessed in a blinded fashion. Only adults in stable health will be eligible in order to minimize participant risk. Only non-pregnant females of childbearing age are eligible, and they must agree to continue adequate contraception for 180 days after injection. Study holding rules and a safety evaluation by a Safety Review Committee (SRC) will be in place. The study will follow a staggered dose-escalation design, with each of four steps introducing a new dose of the adjuvant (30, 60, 120 and 240 μg respectively).

The first dose level of PAL adjuvant FB-631 is 0.5 X 60 µg (i.e., 30 µg), which is half the dose that was found to be most immunogenic in animal studies. The adjuvant is co-administered with 0.25 mL of TIV, which is half the dose of TIV that is routinely administered to adults (i.e. 7.5 μg of each of the three influenza subtypes contained in the vaccine). The next dose level is 60µg of FB-631 combined with 0.25 mL TIV. The third dose level is 120 μg of FB-631 with 0.25 mL TIV. In the fourth and final step the dose of adjuvant is 240 μg of PAL adjuvant combined with 0.25 mL TIV (8 participants) or 0.125 mL TIV (i.e. 3.75 μg HA of each influenza subtype contained in the vaccine) (8 participants).

Any safety signal observed in the study will lead to a hold until the decision of Safety Review Committee to continue, modify or suspend the conduct of the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Flu

• NCT number: NCT02188810
• Study type: Interventional
• Source: Folia Biotech Inc.
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 2014
• Completion date: December 2017