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HealthyPhase 1/2VSG-2011-101NCT01578070

Single-center Study Evaluating the Safety and Efficacy of Viscogel® as Adjuvant in Act-HIB® Vaccine

A Phase 1/2 study testing 0.2μg Act-HIB®, ViscoGel® and 0.2μg Act-HIB® and ViscoGel® and 2μg Act-HIB® in people with Healthy, run by Viscogel AB at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
0.2μg Act-HIB®, ViscoGel® and 0.2μg Act-HIB® and ViscoGel® and 2μg Act-HIB®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteSweden
Study dates
Mar 2012to Dec 2012
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska Trial Alliance

    Stockholm, SE-141 86

Other trials in Sweden

About this study

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

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.

Conditions
Healthy
Being tested
0.2μg Act-HIB®, ViscoGel® and 0.2μg Act-HIB®, ViscoGel® and 2μg Act-HIB®, 2μg Act-HIB®, 10μg Act-HIB®
Keywords
Other and Unspecified Vaccines and Biological Substances Causing Adverse Effects in Therapeutic Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.2μg Act-HIB®Biological

    0.2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.

  • ViscoGel® and 0.2μg Act-HIB®Biological

    Pre-selected dose of ViscoGel® (from phase A) and Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.

  • ViscoGel® and 2μg Act-HIB®Biological

    Pre-selected dose of ViscoGel® (from phase A) and 2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.

  • 2μg Act-HIB®Biological

    2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.

  • 10μg Act-HIB®Biological

    Clinical standard dose of 10μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.

Study groups in NCT01578070
Study groupRoleWhat they receive
ViscoGel® and 0.2μg Act-HIB®ExperimentalNot described
Receives: Biological: ViscoGel® and 0.2μg Act-HIB®
0.2μg Act-HIB®ExperimentalNot described
Receives: Biological: 0.2μg Act-HIB®
ViscoGel® and 2μg Act-HIB®ExperimentalNot described
Receives: Biological: ViscoGel® and 2μg Act-HIB®
2μg Act-HIB®ExperimentalNot described
Receives: Biological: 2μg Act-HIB®
10μg Act-HIB®Active comparatorNot described
Receives: Biological: 10μg Act-HIB®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and type of adverse events, severe adverse events and SUSAR

    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.

    Measured: Up to 28 days post injection

Secondary outcomes (1)

  1. Change in HIB antibody serum titer

    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.

    Measured: 28 days post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01578070
Sponsor's protocol ID
VSG-2011-101
Acronym
VSG-2011-101
Status last verified
Aug 2013
First submitted
11 Apr 2012
Last updated
30 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25218298

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 0.2μg Act-HIB®, ViscoGel® and 0.2μg Act-HIB® and ViscoGel® and 2μg Act-HIB® in people with Healthy, run by Viscogel AB at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and type of adverse events, severe adverse events and SUSAR (time frame: Up to 28 days post injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01578070, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2013.

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