Dose Finding Study of Single Dose GHB11L1 in Healthy Adults (GHB-CS07)
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|ClinicalTrials.gov Identifier: NCT01078701|
Recruitment Status : Completed
First Posted : March 2, 2010
Last Update Posted : January 5, 2011
The purpose of this phase IIa trial is to evaluate the immunogenicity of a single dose of GHB11L1 administered by liquid nasal spray for vaccination against influenza A (H1N1) virus.
This study is also performed to assess safety, tolerability and pharmacokinetics (shedding) of a single dose of GHB11L1 administered by liquid nasal spray.
|Condition or disease||Intervention/treatment||Phase|
|Influenza, Human||Biological: GHB11L1 Biological: Placebo||Phase 2|
GHB11L1 intends to provide a novel vaccination for influenza virus infection. 48 healthy volunteers will be included in this phase IIa study investigating three dose levels. 16 subjects will be randomised at a ratio of 3:1 for GHB11L1 or placebo.
Healthy male volunteers, 18-50 years of age and seronegative with respect to the applied virus antigens (antibody titers <1:10 detected) will be randomised.
GHB11L1 will be administered once on day 1. Follow-up visits will be performed on days 2, 8 and 29.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomised, Double-blind, Placebo-controlled, Phase IIa Dose Finding Study of Single Dose GHB11L1 in Healthy Adults|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Dose levels: 6.0 log10 TCID50/volunteer, 6.5 log10 TCID50/volunteer and 7.0 log10 TCID50/volunteer
GHB11L1 administration by liquid nasal spray at doses of 6.0 log10, 6.5 log10 and 7.0 log10 TCID50/volunteer
Other Name: A/Brisbane/59/07(H1N1)-like delNS1 virus reassortant
Placebo Comparator: SPGN buffer
SPGN buffer administration by liquid nasal spray
Other Name: SPGN buffer
- Local and systemic immune response [ Time Frame: From baseline to day 29 (end of study) ]
- Clinical signs and symptoms, laboratory tests Pharmacokinetics: qualitative assessment of viral recovery (shedding) in nasal mucosal samples. [ Time Frame: From written informed consent to 30 days after end of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078701
|Medical University Vienna, Department of Clinical Pharmacology|
|Vienna, Austria, A-1090|
|Principal Investigator:||Volker Wacheck, MD||Medical University Vienna|