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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Pharma Consulting Group AB | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ViscoGel® and 0.2μg Act-HIB® | Experimental |
| |
| 0.2μg Act-HIB® | Experimental |
| |
| ViscoGel® and 2μg Act-HIB® | Experimental |
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| 2μg Act-HIB® | Experimental |
| |
| 10μg Act-HIB® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.2μg Act-HIB® | Biological | 0.2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nabil Al-Tawil, MD/PhD | KTA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Trial Alliance | Stockholm | SE-141 86 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25218298 | Derived | 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. |
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| ID | Term |
|---|---|
| C514867 | Hiberix |
| C009931 | poly(ethylmethacrylate) |
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| 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. |
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| 10μg Act-HIB® | Biological | Clinical standard dose of 10μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B. |
|
| 28 days post vaccination |