Clinical trial NCT01369862: Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults
Official title: Randomised, Double-blind, Placebo-controlled, Phase I/II Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza, Human
Keywords: live attenuated flu vaccines
influenza A (H1N1)
intranasal application
replication-deficient influenza virus
Lead sponsor: AVIR Green Hills Biotechnology AG
Sponsor class: INDUSTRY
First posted: 2011-06-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Detailed description: 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: 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:
measure: Number of participants with Adverse Events
timeFrame: From baseline to 30 days after end of study
Secondary outcomes:
measure: Seroconversion rates at day 29
timeFrame: At day 29 (end of study)
measure: Determination of the presence of GHB16L2 in mucosal samples (viral recovery/shedding)
timeFrame: 1 week post immunisation
measure: Immune response factor at day 29
timeFrame: At day 29 (end of study)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna, Department of Clinical Pharmacology
Study officials:
affiliation: Medical University Vienna
name: Michael Wolzt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mossler C, Groiss F, Wolzt M, Wolschek M, Seipelt J, Muster T. Phase I/II trial of a replication-deficient trivalent influenza virus vaccine lacking NS1. Vaccine. 2013 Dec 16;31(52):6194-200. doi: 10.1016/j.vaccine.2013.10.061. Epub 2013 Oct 30.