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

NCT01578070 | Completed Phase 1 DMC

• 1 other identifier: VSG-2011-101
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Other and Unspecified Vaccines and Biological Substances Causing Adverse Effects in Therapeutic Use

Outcome Measures

Primary Outcomes (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.

  Up to 28 days post injection

Secondary Outcomes (1)

• Change in HIB antibody serum titer

  28 days post vaccination

Study Arms (5)

ViscoGel® and 0.2μg Act-HIB®

EXPERIMENTAL

Biological: ViscoGel® and 0.2μg Act-HIB®

0.2μg Act-HIB®

EXPERIMENTAL

Biological: 0.2μg Act-HIB®

ViscoGel® and 2μg Act-HIB®

EXPERIMENTAL

Biological: ViscoGel® and 2μg Act-HIB®

2μg Act-HIB®

EXPERIMENTAL

Biological: 2μg Act-HIB®

10μg Act-HIB®

ACTIVE COMPARATOR

Biological: 10μg Act-HIB®

Interventions

0.2μg Act-HIB® BIOLOGICAL

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

0.2μg Act-HIB®

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 0.2μg Act-HIB®

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.

ViscoGel® and 2μg Act-HIB®

2μg Act-HIB® BIOLOGICAL

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

2μg Act-HIB®

10μg Act-HIB® BIOLOGICAL

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

10μg Act-HIB®

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Viscogel AB: lead
• Karolinska Institutet: collaborator
• Pharma Consulting Group AB: collaborator

Study Sites (1)

Karolinska Trial Alliance

Stockholm, SE-141 86, Sweden

Location

Related Publications (1)

• 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.

  PMID: 25218298 DERIVED

MeSH Terms

Interventions

Hiberix; poly(ethylmethacrylate)

Study Officials

• Nabil Al-Tawil, MD/PhD

  KTA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 16, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 30, 2013

Record last verified: 2013-08

Locations

SE (1)