Clinical trial NCT01578070: Single-center Study Evaluating the Safety and Efficacy of Viscogel® as Adjuvant in Act-HIB® Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: Other and Unspecified Vaccines and Biological Substances Causing Adverse Effects in Therapeutic Use
Lead sponsor: Viscogel AB
Sponsor class: INDUSTRY
Collaborators: name: Karolinska Institutet
name: Pharma Consulting Group AB
First posted: 2012-04-16
Enrollment: 130
Sex: ALL
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence and type of adverse events, severe adverse events and SUSAR
timeFrame: Up to 28 days post injection
Secondary outcomes:
measure: Change in HIB antibody serum titer
timeFrame: 28 days post vaccination
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Trial Alliance
Study officials:
affiliation: KTA
name: Nabil Al-Tawil, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.