Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults
Brief Summary
It is the hypothesis of this study that intranasal vaccination with a single dose of GHB04L1 is safe and induces an immune response against influenza A H5N1. This hypothesis will be tested in a randomized, double-blind, placebo-controlled, Phase I dose-escalation study assessing the safety and tolerability of single dose administration of GHB04L1 in healthy adults. Furthermore, the local and systemic immune response as well as the pharmacokinetic properties of a single dose of GHB04L1 will be studied as secondary objectives. GHB04L1 will be escalated according to a fixed dose escalation scheme comprising three dose levels.
Intervention / Treatment
-
GHB04L1 (BIOLOGICAL)single dose intranasal administration of GHB04L1
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Placebo (OTHER)SPGN buffer
Condition or Disease
- Influenza
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 50 Years |
| Enrollment: | 32 (ACTUAL) |
| Funded by: | Industry|Other |
| Allocation: | Randomized |
| Primary Purpose: | Prevention |
Masking |
|
Clinical Trial Dates
| Start date: | Aug 01, 2008 | |
|---|---|---|
| Primary Completion: | Dec 01, 2009 | ACTUAL |
| Completion Date: | Mar 01, 2010 | ACTUAL |
| Study First Posted: | Aug 26, 2008 | ESTIMATED |
| Last Updated: | Mar 01, 2010 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
Eligibility Criteria
| Sex: | Male |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 50 |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* Healthy male volunteers, 18-50 years
* Seronegative for H5N1
* Seronegative for H1N1 (with antibody titers ≤1:20)
* Written informed consent to participate in this study
Exclusion Criteria:
* Acute febrile illness
* Signs of acute or chronic upper or lower tract respiratory illnesses
* History of severe atopy
* Seasonal influenza vaccination from 2006/2007 onwards and/or pandemic influenza vaccination against H5N1
* 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
* 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 H5N1
* Seronegative for H1N1 (with antibody titers ≤1:20)
* Written informed consent to participate in this study
Exclusion Criteria:
* Acute febrile illness
* Signs of acute or chronic upper or lower tract respiratory illnesses
* History of severe atopy
* Seasonal influenza vaccination from 2006/2007 onwards and/or pandemic influenza vaccination against H5N1
* 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
* 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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To evaluate safety and tolerability of GHB04L1 administered as single dose intranasal aerosol for vaccination against influenza A (H5N1) virus. study medication administration until 30 days after end of study
Secondary Outcomes
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To assess local immune response, systemic immune response and pharmacokinetics (shedding) of a single dose of GHB04L1 aerosol administered intranasally. day1 until day 29
More Details
| NCT Number: | NCT00741806 |
|---|---|
| Acronym: | GHB-CS03 |
| Other IDs: | GHB-CS03 |
| Study URL: | https://clinicaltrials.gov/study/NCT00741806 |
Last updated: Sep 29, 2023