Single-center Study Evaluating the Safety and Efficacy of Viscogel® as Adjuvant in Act-HIB® Vaccine
NCT ID: NCT01578070
Last Updated: 2013-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
130 participants
INTERVENTIONAL
2012-03-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ViscoGel® and 0.2μg Act-HIB®
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.
0.2μg Act-HIB®
0.2μg Act-HIB®
0.2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
ViscoGel® and 2μg Act-HIB®
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.
2μg Act-HIB®
2μg Act-HIB®
2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
10μg Act-HIB®
10μg Act-HIB®
Clinical standard dose of 10μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
Interventions
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0.2μg Act-HIB®
0.2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
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.
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.
2μg Act-HIB®
2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
10μg Act-HIB®
Clinical standard dose of 10μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
22 Years
50 Years
ALL
Yes
Sponsors
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Karolinska Institutet
OTHER
Pharma Consulting Group AB
INDUSTRY
Viscogel AB
INDUSTRY
Responsible Party
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Principal Investigators
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Nabil Al-Tawil, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
KTA
Locations
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Karolinska Trial Alliance
Stockholm, , Sweden
Countries
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References
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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.
Other Identifiers
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VSG-2011-101
Identifier Type: -
Identifier Source: org_study_id