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

Phase 1/2 Completed 130 enrolled Viscogel AB Karolinska Institutet · collab Pharma Consulting Group AB · collab

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2012-03
Primary completion: 2012-12
Completion: 2012-12

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ActHIB	Vaccine	0.2 ug	Intramuscular
Subject	ActHIB	Vaccine	2 ug	Intramuscular
Subject	ActHIB	Vaccine	10 ug	Intramuscular
Subject	ViscoGel	Other / unclassified	25 mg	Intramuscular
Subject	ViscoGel	Other / unclassified	50 mg	Intramuscular
Subject	ViscoGel	Other / unclassified	75 mg	Intramuscular

Indications

No indication recorded.