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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014