single-center study evaluating the safety and efficacy of viscogel® as adjuvant in act-hib® vaccine

Conditions: Healthy

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.


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.

Keywords: other and unspecified vaccines and biological substances causing adverse effects in therapeutic use