Seroconversion rates for HAI, MNA, IgA and IgG
Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults
Brief Summary
The purpose of this phase I/II trial is to evaluate safety and tolerability of a single dose of GHB16L2 administered by liquid nasal spray for vaccination against seasonal influenza virus infection. It is also performed to assess immunogenicity and pharmacokinetics (shedding).
Intervention / Treatment
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GHB16L2 (BIOLOGICAL)A/Brisbane/59/07(H1N1)-like delNS1, A/Brisbane/10/07(H3N2)-like delNS1, B/Florida/04/06-like delNS1 virus reassortants
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Placebo (BIOLOGICAL)SPGNH buffer
Condition or Disease
- Influenza, Human
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 60 Years |
| Enrollment: | 80 (ESTIMATED) |
| Funded by: | Industry |
| Allocation: | Randomized |
| Primary Purpose: | Prevention |
Masking |
|
Clinical Trial Dates
| Start date: | Jan 01, 2011 | |
|---|---|---|
| Primary Completion: | Aug 01, 2011 | ACTUAL |
| Completion Date: | Aug 01, 2011 | ACTUAL |
| Study First Posted: | Jun 09, 2011 | ESTIMATED |
| Last Updated: | Jan 09, 2014 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
GHB16L2 intends to provide a novel vaccination for influenza virus infection. 80 healthy volunteers will be included at a ratio of 1:1 for GHB16L2 or placebo. GHB16L2 will be administered once on day 1. Follow-up visits will be performed on days 2, 8 and 29.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 60 |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* Healthy male and female volunteers, 18-60 years
* Seronegative for one or two of the applied vaccine strains
* Low antibody titres for H1N1v
* Written informed consent to participate in this study
* For female volunteers of childbearing potential, provision of a history and current use of reliable contraceptive practices
Exclusion Criteria:
* Acute febrile illness (\>37.3°C)
* Signs of acute or chronic upper or lower tract respiratory illnesses
* History of severe atopy
* Seasonal influenza vaccination in 2008/2009 and/or later seasons and/or pandemic influenza vaccination at any time
* Fever ≥38.0°C in the time period between the pre-screening visit and day 1
* Known increased tendency of nose bleeding
* Volunteers with clinically relevant abnormal paranasal anatomy
* Volunteers with clinically relevant abnormal laboratory values
* In female volunteers of childbearing potential, a positive urine pregnancy test
* 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 4 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 and female volunteers, 18-60 years
* Seronegative for one or two of the applied vaccine strains
* Low antibody titres for H1N1v
* Written informed consent to participate in this study
* For female volunteers of childbearing potential, provision of a history and current use of reliable contraceptive practices
Exclusion Criteria:
* Acute febrile illness (\>37.3°C)
* Signs of acute or chronic upper or lower tract respiratory illnesses
* History of severe atopy
* Seasonal influenza vaccination in 2008/2009 and/or later seasons and/or pandemic influenza vaccination at any time
* Fever ≥38.0°C in the time period between the pre-screening visit and day 1
* Known increased tendency of nose bleeding
* Volunteers with clinically relevant abnormal paranasal anatomy
* Volunteers with clinically relevant abnormal laboratory values
* In female volunteers of childbearing potential, a positive urine pregnancy test
* 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 4 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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Number of participants with Adverse Events From baseline to 30 days after end of study
Secondary Outcomes
-
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Determination of the presence of GHB16L2 in mucosal samples (viral recovery/shedding) 1 week post immunisation
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Immune response factors for HAI, MNA, IgA and IgG
More Details
| NCT Number: | NCT01369862 |
|---|---|
| Other IDs: | GHB-CS08 |
| Study URL: | https://clinicaltrials.gov/study/NCT01369862 |
Last updated: Sep 29, 2023