We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01578070
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : August 30, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : March 2012
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Incidence and type of adverse events, severe adverse events and SUSAR [ Time Frame: 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 Outcome Measures :
  1. Change in HIB antibody serum titer [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   22 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578070

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Viscogel AB
ClinicalTrials.gov Identifier: NCT01578070     History of Changes
Other Study ID Numbers: VSG-2011-101
First Posted: April 16, 2012    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: August 2013

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

Additional relevant MeSH terms:
Salicylic Acid
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents