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

Viscogel

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy

Treatments: Biological: ViscoGel® and 2μg Act-HIB®; Biological: ViscoGel® and 0.2μg Act-HIB®; Biological: 10μg Act-HIB®; Biological: 0.2μg Act-HIB®; Biological: 2μg Act-HIB®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01578070

VSG-2011-101

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 22 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 5 patient groups

ViscoGel® and 0.2μg Act-HIB®

Experimental group

Treatment:

Biological: ViscoGel® and 0.2μg Act-HIB®

0.2μg Act-HIB®

Experimental group

Treatment:

Biological: 0.2μg Act-HIB®

ViscoGel® and 2μg Act-HIB®

Experimental group

Treatment:

Biological: ViscoGel® and 2μg Act-HIB®

2μg Act-HIB®

Experimental group

Treatment:

Biological: 2μg Act-HIB®

10μg Act-HIB®

Active Comparator group

Treatment:

Biological: 10μg Act-HIB®