Single-center Study Evaluating the Safety and Efficacy of Viscogel® as Adjuvant in Act-HIB® Vaccine (VSG-2011-101)

A Single-centre Study Evaluating the Safety of ViscoGel® and Its Safety and Efficacy as an Adjuvant in Act-HIB® Vaccine Administered by Intramuscular Injection to Healthy Volunteers in a Single-blind Randomised, Parallel-group Design

The purpose of this study is to show that ViscoGel® is safe when administrated alone and as an adjuvant together with Act-HIB® vaccine in healthy volunteers and to evaluate the quantitative and qualitative effect on the immune response.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: ViscoGel® and 0.2μg Act-HIB®; Biological: 0.2μg Act-HIB®; Biological: ViscoGel® and 2μg Act-HIB®; Biological: 2μg Act-HIB®; Biological: 10μg Act-HIB®

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, SE-141 86
    • Karolinska Trial Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who have signed a written informed consent consistent with ICH GCP guidelines and local legislations prior to participation in the trial.
• Subjects who are healthy and with no relevant medical history as determined by the investigator.
• Subject that has not previously been known to be infected with or vaccinated against HIB, or exposed to patients diseased with HIB within a 4 months period prior to screening.
• Male and non-lactating female subjects 22-50 years of age.
• Two negative pregnancy tests if female (at screening and day 0)
• Contraceptive use if female i.e. using a highly effective contraceptive method (implants, injectables, combined oral contraceptives, intra-uterine devices [including hormonal intra-uterine devices], sexual abstinence or vasectomised partner) for at least one month before dosing and willing to use it for at least one month after dosing.
• Able to read and write Swedish.

Exclusion Criteria:

• Known allergy to any component in Act-HIB, or who have had a serious reaction after previous administration of a vaccine.
• Fever or acute disease including fever.
• Receipt of immunoglobulins or blood products within three months prior to screening.
• Donation of blood or suffered of blood loss of 450 ml within 3 months (4 months if female) prior to screening.
• Donation of plasma within 14 days prior to screening.
• Participation in other clinical study within 3 months prior to screening or previously dosed in this study.
• Known or suspected immunodeficiency.
• Vaccination received within a 2 months period prior to screening.
• Any condition where regular use of inhaled, topical or oral corticosteroid is used.
• Any condition where use of immunosuppressant is needed, e.g rheumatoid arthitis, cancer, transplantation, or treatment with immunomodulators, e.g. anti-TNF alpha, methotrexte, thioguanine, cyclophosphamide, cyclosporine, tacrolimus.
• Smoker or user of other nicotine products at the discretion of the investigator.
• Drug or alcohol abuse or history of drug or alcohol abuse in the past 5 years prior to screening.
• Any medical condition or other circumstances that in the opinion of the investigator might interfere with the study.
• Abnormal clinically significant laboratory values, ECG findings, vital signs or physical examination findings as judged by the investigator.
• Inability to adhere to the protocol including plans to move from the area.
• Use of any prohibited medication (including dietary supplements and herbal medication) within 2 weeks or 7 half-lives (whichever is longer) of day 0.
• Any positive result at screening for serum hepatitis B surface antigen (HBsAG), hepatitis C antibody (anti-HCV) or human immunodeficiency virus (HIV) I and II.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ViscoGel® and 0.2μg Act-HIB®	Biological: ViscoGel® and 0.2μg Act-HIB®; Pre-selected dose of ViscoGel® (from phase A) and Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
EXPERIMENTAL: 0.2μg Act-HIB®	Biological: 0.2μg Act-HIB®; 0.2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
EXPERIMENTAL: ViscoGel® and 2μg Act-HIB®	Biological: ViscoGel® and 2μg Act-HIB®; Pre-selected dose of ViscoGel® (from phase A) and 2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
EXPERIMENTAL: 2μg Act-HIB®	Biological: 2μg Act-HIB®; 2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
ACTIVE_COMPARATOR: 10μg Act-HIB®	Biological: 10μg Act-HIB®; Clinical standard dose of 10μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and type of adverse events, severe adverse events and SUSAR	Phase A: 3 consecutive groups each of 10 subjects. Planned dose of ViscoGel® (provided that the data safety monitoring board deemed the previous dose level to be safe): 25mg, 50mg and 75mg.	Up to 28 days post injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HIB antibody serum titer	Phase B: The ViscoGel® dose administrated will be chosen after evaluation of safety and tolerance in Phase A. 2 subjects from group 1 and 2 subjects from group 3 will initially receive ViscoGel® dose (from phase A) with Act-HIB non-randomized. The remaining subjects will be randomized to 5 different treatment arms. Group 1; ViscoGel® with 0.2µg Act-HIB, Group 2; 0.2µg Act-HIB, Group 3; ViscoGel® with 2µg Act-HIB, Group 4; 2µg Act-HIB and Group 5 10µg Act-HIB is given. Blood samples are obtained at baseline and post-injection for assessment of HIB antibody serum titer.	28 days post vaccination

Collaborators and Investigators

• Sponsor: Viscogel AB
• Collaborators: Karolinska Institutet; Pharma Consulting Group AB
• Investigators: Principal Investigator: Nabil Al-Tawil, MD/PhD, KTA

Publications and helpful links

General Publications

• Neimert-Andersson T, Binnmyr J, Enoksson M, Langeback J, Zettergren L, Hallgren AC, Franzen H, Lind Enoksson S, Lafolie P, Lindberg A, Al-Tawil N, Andersson M, Singer P, Gronlund H, Gafvelin G. Evaluation of safety and efficacy as an adjuvant for the chitosan-based vaccine delivery vehicle ViscoGel in a single-blind randomised Phase I/IIa clinical trial. Vaccine. 2014 Oct 14;32(45):5967-74. doi: 10.1016/j.vaccine.2014.08.057. Epub 2014 Sep 16.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: April 11, 2012
• First Submitted That Met QC Criteria: April 12, 2012
• First Posted (ESTIMATE): April 16, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 30, 2013
• Last Update Submitted That Met QC Criteria: August 29, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Other and Unspecified Vaccines and Biological Substances Causing Adverse Effects in Therapeutic Use
• Additional Relevant MeSH Terms: Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: VSG-2011-101