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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: ViscoGel® and 0.2μg Act-HIB®; Biological: 0.2μg Act-HIB®; Biological: ViscoGel® and 2μg Act-HIB®; Biological: 2μg Act-HIB®; Biological: 10μg Act-HIB®

• Registration Number: NCT01578070
• Lead Sponsor: Viscogel AB

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-12
• Study First Posted: 2012-04-16
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-29
• Last Update Posted: 2013-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ViscoGel® and 0.2μg Act-HIB®	ViscoGel® and 0.2μg Act-HIB®	-
0.2μg Act-HIB®	0.2μg Act-HIB®	-
ViscoGel® and 2μg Act-HIB®	ViscoGel® and 2μg Act-HIB®	-
2μg Act-HIB®	2μg Act-HIB®	-
10μg Act-HIB®	10μg Act-HIB®	-

Primary Outcome Measures

Name	Time	Method
Incidence and type of adverse events, severe adverse events and SUSAR	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

Name	Time	Method
Change in HIB antibody serum titer	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.

Trial Locations

Locations (1)

Karolinska Trial Alliance; 🇸🇪 Stockholm, Sweden