NCT00908687

Brief Summary

This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high dose) on Day 0 with or without a patch (low or high dose).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2009

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

March 13, 2014

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

8 months

First QC Date

May 22, 2009

Results QC Date

January 30, 2014

Last Update Submit

December 9, 2021

Conditions

Pandemic Influenza

Outcome Measures

Primary Outcomes (1)

  • Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28.

    Seroconversion is defined as either 1) baseline HI titer \< 1:10 and a post-vaccination HI titer ≥ 1:40, or 2) baseline HI titer ≥ 1:10 and a minimum four-fold rise. Seroprotection is defined as a post-vaccination HI antibody titer ≥ 1:40. FDA/EMEA criterion for seroconversion was to meet or exceed 40%. FDA/EMEA criterion for seroprotection was to meet or exceed 70%.

    Day 28

Secondary Outcomes (2)

  • Safety of A/H5N1 Vaccine IM Injection With and Without an LT Adjuvant Patch

    6 months

  • Evaluate Treatment Group HI Responses Against US FDA Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (May 2007) and EMA CPMP/BWP/214/96 Criteria for Immunogenicity

    Day 28

Study Arms (6)

Group 1: 30 µg HA, no LT patch

EXPERIMENTAL

A/H5N1 Vaccine 30 µg HA i.m. on Day 0

Biological: A/H5N1

Group 2: 30 µg HA + 50 µg LT patch

EXPERIMENTAL

A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0

Biological: A/H5N1Biological: LT Adjuvant Patch

Group 3: 30 µg HA + 100 µg LT patch

EXPERIMENTAL

A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0

Biological: A/H5N1Biological: LT Adjuvant Patch

Group 4: 45 µg HA, no LT patch

EXPERIMENTAL

A/H5N1 Vaccine 45 µg HA i.m. on Day 0

Biological: A/H5N1

Group 5: 45 µg HA + 50 µg LT patch

EXPERIMENTAL

A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0

Biological: A/H5N1Biological: LT Adjuvant Patch

Group 6: 45 µg HA + 100 µg LT patch

EXPERIMENTAL

A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0

Biological: A/H5N1Biological: LT Adjuvant Patch

Interventions

A/H5N1BIOLOGICAL

A/H5N1 Low Dose

Group 1: 30 µg HA, no LT patchGroup 2: 30 µg HA + 50 µg LT patchGroup 3: 30 µg HA + 100 µg LT patch
LT Adjuvant PatchBIOLOGICAL

LT Adjuvant Patch Low Dose

Group 2: 30 µg HA + 50 µg LT patchGroup 5: 45 µg HA + 50 µg LT patch

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult male or females 18 to 49 years of age (inclusive)
  • Signed Informed Consent
  • Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and within 24 hours of vaccination with understanding (through informed Consent process) to not become pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide) and IUD

You may not qualify if:

  • Clinically significant laboratory abnormalities at screening
  • Abnormalities at physical examination \[as determined by the Toxicity Grading Scale (grade 1-4)\]
  • Known allergies to any component of the vaccine
  • Known egg protein allergy
  • Known allergies to adhesives
  • Known disturbance of coagulation
  • Participated in research involving investigational product within 45 days before planned date of vaccination
  • Donated or received blood or blood products such as plasma within the past 45 days
  • Received any licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to planned date of vaccination
  • Ever received investigational enterotoxigenic E. coli, or LT (R192G) or NasalFlu, Berna Biotech Ltd
  • Ever received cholera toxin or vaccine (e.g. Orochol, Dukoral)
  • History of abdominal surgery (excluding C-Section, hysterectomy, cosmetic surgery, liposuction, appendectomy, cholecystectomy, ventral hernia repair, and other surgeries not pertaining to gastrointestinal problems) or history of, or recent acute gastrointestinal (GI) illness
  • Previous vaccination with a pandemic vaccine or previous proven contact with A/H5N1 wild type virus (contact with an individual with laboratory-confirmed A/H5N1 infection or contact with an animal which died as a result of A/H5N1 infection)
  • Recent or regular use of oral, topical or injected steroid medications within 45 days prior to vaccination
  • Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to vaccination
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Solano Clinical Research

Vallejo, California, 94589, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Accelovance

South Bend, Indiana, 46601, United States

Location

Johnson County Clinical Trials

Lenexa, Kansas, 66219, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Results Point of Contact

Title
Head Clinical Development
Organization
Valneva Austria GmbH
info@valneva.com
0043120620

Study Officials

  • Eric Sheldon, MD

    Miami Research Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2009

First Posted

May 27, 2009

Study Start

May 1, 2009

Primary Completion

January 1, 2010

Study Completion

July 1, 2011

Last Updated

December 10, 2021

Results First Posted

March 13, 2014

Record last verified: 2021-12

Locations

US(6)