A Randomised, Double-blind, Placebo-controlled Phase IIb Trial to Test FLU-v Vaccine

Summary

FLU-v is a vaccine that aims to protect against a wide range of flu viruses. The purpose of this study is to measure the immune responses induced by FLU-v vaccine. This study will look at how safe FLU-v is when administered and how successful it is in preventing flu or reducing the severity of the flu symptoms.

The study requires 222 healthy volunteers 18-60 years old. Participation in the study will take a maximum of 7 months and consists of 5 visits. During visit 1, subjects will be examined by a doctor to make sure they are eligible to enter the study. A 15ml blood sample (a tablespoon) will be taken to check general health followed by a general physical exam. Medical history and some personal information will be collected. Subjects that have received the traditional flu vaccine in the past 6 months, and those females who are pregnant or breastfeeding will not be allowed in the study. Subjects of childbearing age must agree to use effective contraceptive methods.

At visit 2, subjects will be randomly allocated to one of the four treatment groups summarised below:

* Treatment 1: FLU-v (test vaccine) at the start of the study (Day 0) and then again 21 days later
* Treatment 2: FLU-v (test vaccine) with an additional substance added \[known as Montanide ISA 51\] which improves the effect of the test vaccine. Injection will be given on Day 0 and then Placebo (no test vaccine) alone 21 days later
* Treatment 3: Placebo (no test vaccine) injection on Day 0 and then 21 days later
* Treatment 4: Placebo (no test vaccine) with an additional substance added \[known as Montanide ISA 51\] on Day 0 and then Placebo (no test vaccine) alone 21 days later Treatment will be injected under the skin in the upper arm on day 0 (visit 2) and 21 days later (visit 3). Blood samples will be taken before treatment (day 0), and on days 42 (visit 4) and 180 (visit 5) to the immune responses induced by the vaccine.

Subjects will be asked to complete a diary card to write down any side effects that they may experience after vaccination. Subjects will also be asked to complete another diary card to document any flu-like symptoms experienced between December 2016 and March 2017, this time is officially considered as the flu season. During this period, if the subject experiences flu-like symptoms, a collection of a nose and tonsil swab will be arranged by the study site to confirm whether they have the flu or not.

Conditions

• Influenza

Interventions

BIOLOGICAL

FLU-v

Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH

BIOLOGICAL

adjuvanted FLU-v

Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection

BIOLOGICAL

Saline

Subcutaneous injection in the upper arm with 0.5ml of saline

BIOLOGICAL

Adjuvanted placebo

Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection

Sponsors & Collaborators

• Seventh Framework Programme

  collaborator OTHER

• University of Groningen

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• Robert Koch Institut

  collaborator OTHER_GOV

• Norwegian Institute of Public Health

  collaborator OTHER_GOV

• PepTcell Limited

  lead INDUSTRY

Principal Investigators

• Paul Groeneveld, PhD · Isala

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2017-07-18

Completion

2017-07-18

Countries

• Netherlands

Study Locations