Healthy
Conditions
Keywords
Other and Unspecified Vaccines and Biological Substances Causing Adverse Effects in Therapeutic Use
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.
Interventions
BIOLOGICAL0.2μg Act-HIB®
0.2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
BIOLOGICALViscoGel® 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.
BIOLOGICALViscoGel® 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.
BIOLOGICAL2μg Act-HIB®
2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
BIOLOGICAL10μg Act-HIB®
Clinical standard dose of 10μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
Sponsors
Karolinska Institutet
Pharma Consulting Group AB
Viscogel AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and type of adverse events, severe adverse events and SUSAR | Up to 28 days post injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HIB antibody serum titer | 28 days post vaccination | 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. |
Countries
Sweden
Outcome results
None listed