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

August 29, 2013 updated by: Viscogel AB

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, SE-141 86
        • Karolinska Trial Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 28 days post injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
28 days post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Viscogel AB

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karolinska Institutet
Pharma Consulting Group AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nabil Al-Tawil, MD/PhD, KTA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VSG-2011-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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