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

    A/Brisbane/59/07(H1N1)-like delNS1, A/Brisbane/10/07(H3N2)-like delNS1, B/Florida/04/06-like delNS1 virus reassortants
  • Placebo (BIOLOGICAL)
    SPGNH buffer

Condition or Disease

  • Influenza, Human


Study Design

Status: Completed
Study results: No Results Available
Age: 18 Years to 60 Years
Enrollment: 80 (ESTIMATED)
Funded by: Industry
Allocation: Randomized
Primary Purpose: Prevention


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


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

Primary Outcomes
  • Number of participants with Adverse Events From baseline to 30 days after end of study
Secondary Outcomes
  • Seroconversion rates for HAI, MNA, IgA and IgG

  • Determination of the presence of GHB16L2 in mucosal samples (viral recovery/shedding) 1 week post immunisation
  • Immune response factors for HAI, MNA, IgA and IgG

More Details

NCT Number: NCT01369862
Other IDs: GHB-CS08
Study URL:
Last updated: Sep 29, 2023