Study to Assess Safety of an Inactivated H5N1 Influenza Vaccine Administered in GelVac Nasal Powder to Healthy Young Adults

NCT01258062 | Completed Phase 1

• 1 other identifier: 2009-GEL-NT/001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of age who are eligible for study participation will be enrolled in the trial. It is expected that 10 subjects will be screened to obtain 7 subjects who will be eligible for study participation. The primary objective is to determine the frequency and severity of local and systemic adverse events of vaccine. The secondary objective is to assess the immunogenicity of the vaccine based on geometric mean titers (GMT) of serum HAI, serum neutralizing, and nasal wash IgA antibodies.

Conditions

Phase 1 Safety Study of GelVac Nasal Powder H5N1 Influenza Vaccine

Outcome Measures

Primary Outcomes (1)

• The primary objective is to determine the frequency of adverse events of the vaccine.

  up to 26 weeks

Secondary Outcomes (1)

• The secondary objective is to assess the immunogenicity of the vaccine based on geometric mean titers (GMT) of serum HAI.

  up to 26 weeks

Study Arms (2)

of GelVac™ nasal powder H5N1 influenza vaccine.

EXPERIMENTAL

Drug: GelVac™ nasal powder H5N1 influenza vaccine.

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

GelVac™ nasal powder H5N1 influenza vaccine. DRUG

subjects will be randomized to either 30 µg of Inactivated H5N1 Influenza Vaccine Administered in GelVac™ Nasal Powder given as two doses of 15 μg in one nostril or placebo vaccine given as two doses administered in GelVac™ Nasal Powder in one nostril

of GelVac™ nasal powder H5N1 influenza vaccine.

Placebo DRUG

subjects will be randomized to either 30 µg of Inactivated H5N1 Influenza Vaccine Administered in GelVac™ Nasal Powder given as two doses of 15 μg in one nostril or placebo vaccine given as two doses administered in GelVac™ Nasal Powder in one nostril

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• able to read and sign Informed Consent Form (ICF).
• male or female \> 18 and \< 49 years of age at the time the ICF is signed.
• generally healthy, as determined by medical history and clinical assessment.
• able to attend all scheduled visits and to comply with all trial procedures.
• if female of child-bearing potential, use of an acceptable method of contraception or abstinence for at least 4 weeks prior to the first vaccination through at least four weeks after the second vaccination. Acceptable methods are hormonal birth control or a barrier method with spermicide.
• if female, post menopausal (no menstrual period within the last 12 months), surgically sterile (hysterectomy or tubal ligation), or have a negative urine pregnancy test within 24 hours prior to the time of vaccination.

You may not qualify if:

• has a known allergy to fruits (e.g., apples, oranges) or pectin and/or pectin by-products (including jams or jellies).
• has a known allergy to dairy/milk products/lactose.
• is breast-feeding or pregnant or planning on becoming pregnant within 1 month of vaccination.
• has a history of a chronic viral infection (i.e.; Shingles, Herpes Zoster, HIV).
• has a history of severe allergic reaction following influenza vaccination, systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing the same substances.
• has a history of demyelinating disease (esp. Guillian-Barre Syndrome).
• history of Bell's Palsy.
• immunosuppression as a result of underlying illness or treatment.
• use of oral steroids, parenteral steroids, or high-dose inhaled steroids (\>800 µg/day of beclomethasone dipropionate or equivalent) within 1 month prior to vaccination.
• use of other immunosuppressive or cytotoxic drugs or radiation therapy within six months prior to vaccination.
• use of OTC or other 'herbal' immune suppressant or stimulants within the 6 months prior to vaccination.
• active neoplastic disease or history of any hematologic malignancy in the past 5 years (except localized skin or prostate cancer that is stable in the absence of therapy).
• acute or chronic condition that (in the opinion of the Investigator) would render vaccination unsafe or would interfere with the evaluation of responses including, but not limited to the following: known chronic liver disease, significant renal disease, oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV, unstable or progressive neurologic disorder, insulin-treated diabetes mellitus, and asthma.
• use of experimental vaccines within 6 months prior to study entry, or expected use of experimental vaccines during the entire study period after inoculation with study vaccine.
• participation in another clinical trial 30 days prior to study entry.

Sponsors & Collaborators

• Alachua Government Services, Inc.: lead

Study Sites (1)

Florida Research Network, LLC

Gainesville, Florida, 32605, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 10, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 2, 2017

Record last verified: 2017-02

Locations

US (1)