Single-center Study Evaluating the Safety and Efficacy of Viscogel® as Adjuvant in Act-HIB® Vaccine

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: 0.2μg Act-HIB®
* Biological: ViscoGel® and 0.2μg Act-HIB®
* Biological: ViscoGel® and 2μg Act-HIB®
* Biological: 2μg Act-HIB®
* Biological: 10μg Act-HIB®


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ViscoGel® and 0.2μg Act-HIB®<br> | Biological: ViscoGel® and 0.2μg Act-HIB®<br>* Pre-selected dose of ViscoGel® (from phase A) and Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.<br>|
| Experimental: 0.2μg Act-HIB®<br> | Biological: 0.2μg Act-HIB®<br>* 0.2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.<br>|
| Experimental: ViscoGel® and 2μg Act-HIB®<br> | Biological: ViscoGel® and 2μg Act-HIB®<br>* Pre-selected dose of ViscoGel® (from phase A) and 2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.<br>|
| Experimental: 2μg Act-HIB®<br> | Biological: 2μg Act-HIB®<br>* 2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.<br>|
| Active Comparator: 10μg Act-HIB®<br> | Biological: 10μg Act-HIB®<br>* Clinical standard dose of 10μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Other and Unspecified Vaccines and Biological Substances Causing Adverse Effects in Therapeutic Use