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

This study has been completed.
Sponsor:
Collaborators:
Karolinska Institutet
Pharma Consulting Group AB
Information provided by (Responsible Party):
Viscogel AB
ClinicalTrials.gov Identifier:
NCT01578070
First received: April 11, 2012
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Biological: 0.2μg Act-HIB®
Biological: ViscoGel® and 0.2μg Act-HIB®
Biological: ViscoGel® and 2μg Act-HIB®
Biological: 2μg Act-HIB®
Biological: 10μg Act-HIB®
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Viscogel AB:

Primary Outcome Measures:
  • Incidence and type of adverse events, severe adverse events and SUSAR [ Time Frame: Up to 28 days post injection ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Change in HIB antibody serum titer [ Time Frame: 28 days post vaccination ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 130
Study Start Date: March 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ViscoGel® and 0.2μg Act-HIB® Biological: 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.
Experimental: 0.2μg Act-HIB® Biological: 0.2μg Act-HIB®
0.2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
Experimental: ViscoGel® and 2μg Act-HIB® Biological: 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.
Experimental: 2μg Act-HIB® Biological: 2μg Act-HIB®
2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
Active Comparator: 10μg Act-HIB® Biological: 10μg Act-HIB®
Clinical standard dose of 10μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.

  Eligibility

Ages Eligible for Study:   22 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578070

Locations
Sweden
Karolinska Trial Alliance
Stockholm, Sweden, SE-141 86
Sponsors and Collaborators
Viscogel AB
Karolinska Institutet
Pharma Consulting Group AB
Investigators
Principal Investigator: Nabil Al-Tawil, MD/PhD KTA
  More Information

Additional Information:
No publications provided

Responsible Party: Viscogel AB
ClinicalTrials.gov Identifier: NCT01578070     History of Changes
Other Study ID Numbers: VSG-2011-101
Study First Received: April 11, 2012
Last Updated: August 29, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by Viscogel AB:
Other and Unspecified Vaccines and Biological Substances Causing Adverse Effects in Therapeutic Use

Additional relevant MeSH terms:
Salicylic Acid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on April 22, 2014