Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults

Influenza, Human Clinical Trial

Official title:

Randomised, Double-blind, Placebo-controlled, Phase I/II Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369862
• Other study ID #: GHB-CS08
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 4, 2011
• Last updated: January 9, 2014
• Start date: January 2011
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: AVIR Green Hills Biotechnology AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Biological:
• GHB16L2
A/Brisbane/59/07(H1N1)-like delNS1, A/Brisbane/10/07(H3N2)-like delNS1, B/Florida/04/06-like delNS1 virus reassortants
• Placebo
SPGNH buffer

Locations

Country	Name	City	State
Austria	Medical University Vienna, Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
AVIR Green Hills Biotechnology AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events		From baseline to 30 days after end of study	Yes
Secondary	Seroconversion rates at day 29	Seroconversion rates for HAI, MNA, IgA and IgG	At day 29 (end of study)	No
Secondary	Determination of the presence of GHB16L2 in mucosal samples (viral recovery/shedding)		1 week post immunisation	Yes
Secondary	Immune response factor at day 29	Immune response factors for HAI, MNA, IgA and IgG	At day 29 (end of study)	No