Dose Finding Study of Single Dose GHB11L1 in Healthy Adults
Brief Summary
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.
Intervention / Treatment
-
GHB11L1 (BIOLOGICAL)GHB11L1 administration by liquid nasal spray at doses of 6.0 log10, 6.5 log10 and 7.0 log10 TCID50/volunteer
-
Placebo (BIOLOGICAL)SPGN buffer
Condition or Disease
- Influenza, Human
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 50 Years |
| Enrollment: | 49 (ACTUAL) |
| Funded by: | Industry |
| Allocation: | Randomized |
| Primary Purpose: | Prevention |
Masking |
|
Clinical Trial Dates
| Start date: | Dec 01, 2009 | |
|---|---|---|
| Primary Completion: | May 01, 2010 | ACTUAL |
| Completion Date: | May 01, 2010 | ACTUAL |
| Study First Posted: | Mar 02, 2010 | ESTIMATED |
| Last Updated: | Jan 04, 2011 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
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.
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.
Eligibility Criteria
| Sex: | Male |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 50 |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* Healthy male volunteers, 18-50 years
* Seronegative for H1N1 (Influenza A/Brisbane/59/07 antibody titres \<1:10 detected in haemagglutination inhibition assay)
* Written informed consent to participate in this study
Exclusion Criteria:
* Acute febrile illness (\>37.0°C)
* Signs of acute or chronic upper or lower tract respiratory illnesses (sneezing, cough, tonsillitis, otitis etc.)
* History of severe atopy
* Seasonal influenza vaccination in 2007/2008 and/or later seasons and/or pandemic influenza vaccination at any time
* Known increased tendency of nose bleeding
* Volunteers with clinically relevant abnormal paranasal anatomy
* Volunteers with clinically relevant abnormal laboratory values
* Simultaneous treatment with immunosuppressive drugs incl. Corticosteroids (≥2 weeks) within 4 weeks prior to study medication application
* Clinically relevant history of renal, hepatic, GI, cardiovascular, haematological, skin, endocrine, neurological or immunological diseases
* History of leukaemia or cancer
* HIV or Hepatitis B or C seropositivity
* Volunteers who underwent rhino or sinus surgery, or surgery of another traumatic injury of the nose within 30 days prior to application of study medication
* Volunteers who have received antiviral drugs, treatment with immunoglobulins or blood transfusions, or an investigational drug within four weeks prior to study medication application
* Volunteers who have received anti-inflammatory drugs 2 days prior to study medication application
* Volunteers who are not likely to cope with the requirements of the study or with a significant physical or mental condition that may interfere with the completion of the study
* Healthy male volunteers, 18-50 years
* Seronegative for H1N1 (Influenza A/Brisbane/59/07 antibody titres \<1:10 detected in haemagglutination inhibition assay)
* Written informed consent to participate in this study
Exclusion Criteria:
* Acute febrile illness (\>37.0°C)
* Signs of acute or chronic upper or lower tract respiratory illnesses (sneezing, cough, tonsillitis, otitis etc.)
* History of severe atopy
* Seasonal influenza vaccination in 2007/2008 and/or later seasons and/or pandemic influenza vaccination at any time
* Known increased tendency of nose bleeding
* Volunteers with clinically relevant abnormal paranasal anatomy
* Volunteers with clinically relevant abnormal laboratory values
* Simultaneous treatment with immunosuppressive drugs incl. Corticosteroids (≥2 weeks) within 4 weeks prior to study medication application
* Clinically relevant history of renal, hepatic, GI, cardiovascular, haematological, skin, endocrine, neurological or immunological diseases
* History of leukaemia or cancer
* HIV or Hepatitis B or C seropositivity
* Volunteers who underwent rhino or sinus surgery, or surgery of another traumatic injury of the nose within 30 days prior to application of study medication
* Volunteers who have received antiviral drugs, treatment with immunoglobulins or blood transfusions, or an investigational drug within four weeks prior to study medication application
* Volunteers who have received anti-inflammatory drugs 2 days prior to study medication application
* Volunteers who are not likely to cope with the requirements of the study or with a significant physical or mental condition that may interfere with the completion of the study
Primary Outcomes
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Local and systemic immune response From baseline to day 29 (end of study)
Secondary Outcomes
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Clinical signs and symptoms, laboratory tests Pharmacokinetics: qualitative assessment of viral recovery (shedding) in nasal mucosal samples. From written informed consent to 30 days after end of study
More Details
| NCT Number: | NCT01078701 |
|---|---|
| Acronym: | GHB-CS07 |
| Other IDs: | GHB-CS07 |
| Study URL: | https://clinicaltrials.gov/study/NCT01078701 |
Last updated: Sep 29, 2023