Single-center Study Evaluating the Safety and Efficacy of Viscogel® as Adjuvant in Act-HIB® Vaccine (VSG-2011-101)
|ClinicalTrials.gov Identifier: NCT01578070|
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : August 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: 0.2μg Act-HIB® Biological: ViscoGel® and 0.2μg Act-HIB® Biological: ViscoGel® and 2μg Act-HIB® Biological: 2μg Act-HIB® Biological: 10μg Act-HIB®||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||March 2012|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
|Experimental: ViscoGel® and 0.2μg Act-HIB®||
Biological: ViscoGel® and 0.2μg Act-HIB®
Pre-selected dose of ViscoGel® (from phase A) and Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
|Experimental: 0.2μg Act-HIB®||
Biological: 0.2μg Act-HIB®
0.2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
|Experimental: ViscoGel® and 2μg Act-HIB®||
Biological: ViscoGel® and 2μg Act-HIB®
Pre-selected dose of ViscoGel® (from phase A) and 2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
|Experimental: 2μg Act-HIB®||
Biological: 2μg Act-HIB®
2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
|Active Comparator: 10μg Act-HIB®||
Biological: 10μg Act-HIB®
Clinical standard dose of 10μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
- Incidence and type of adverse events, severe adverse events and SUSAR [ Time Frame: 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.
- Change in HIB antibody serum titer [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578070
|Karolinska Trial Alliance|
|Stockholm, Sweden, SE-141 86|
|Principal Investigator:||Nabil Al-Tawil, MD/PhD||KTA|