A/H5N1 Dose Ranging Study With Adjuvant Patch

NCT00532792 | Completed Phase 1 DMC

• 2 other identifiers: PLA101HHSSO100200700031C
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 5

Brief Summary

This is a Phase 1/2, randomized, observer-blind, placebo-controlled clinical trial. A maximum of 500 eligible subjects in 10 groups will be enrolled, randomized and vaccinated in this study. Subjects will receive an intramuscular injection of either the influenza A/H5N1 (low, medium or high dose) or placebo on Day 0 and Day 21 with or without a patch. This study will be performed in two parts. In Part 1, an initial safety evaluation will be performed in 100 randomized subjects. A Safety Review Committee (SRC)will review all safety data, including laboratory values, through the Day 7 visit, and compare those data against Stopping Criteria. If the treatments are considered safe, Part 2 of the study will be initiated and a second vaccination will be administered to subjects in Part 1 on Day 21. In Part 2, the remaining 400 subjects will be randomized, treated, and will follow the same visit structure and protocol-defined requirements as subjects in Part 1, without the additional laboratory safety measurements. An SRC review will also be performed of all safety data through the Day 28 visit for subjects participating in Part 1.

Conditions

Pandemic Influenza

Keywords

Avian; Pandemic; Influenza; A/H5N1

Outcome Measures

Primary Outcomes (1)

• Safety of Intramuscular A/H5N1 with and without the LT adjuvant patch

  6 months

Secondary Outcomes (1)

• Demonstration of adjuvant effect and evaluation of immunogenicity

  Day 42

Study Arms (10)

Group 1

EXPERIMENTAL

Biological: A/H5N1

Group 2

EXPERIMENTAL

Biological: A/H5N1

Group 3

EXPERIMENTAL

Biological: A/H5N1

Group 4

EXPERIMENTAL

Biological: A/H5N1

Group 5

EXPERIMENTAL

Biological: A/H5N1

Group 6

EXPERIMENTAL

Biological: A/H5N1

Group 7

EXPERIMENTAL

Biological: A/H5N1

Group 8

EXPERIMENTAL

Biological: A/H5N1

Group 9

EXPERIMENTAL

Biological: A/H5N1

Group 10

PLACEBO COMPARATOR

Biological: Placebo

Interventions

A/H5N1 BIOLOGICAL

Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21

Group 1

Placebo BIOLOGICAL

Placebo (0.5ml); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21

Group 10

Eligibility Criteria

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

You may qualify if:

• Healthy adult males or females 18-49 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 each vaccination with understanding (through Informed Consent process) to not become pregnant and 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:

• Laboratory abnormalities \[as determined by the Toxicity Grading Scale (grade 1 4)\] at laboratory 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 first 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 first vaccination
• Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd
• Ever received cholera toxin or vaccine (e.g. Orochol™, Dukoral™)
• History of travelers' diarrhea in the last two years
• 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 illness
• Previous vaccination with a pandemic candidate 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 first vaccination

Sponsors & Collaborators

• Intercell USA, Inc.: lead
• Department of Health and Human Services: collaborator

Study Sites (5)

Solano Clinical Research

Vallejo, California, 94589, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Quintiles Phase One Services

Kansas City, Kansas, 66211, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Northwest Kinetics

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Philip Leese, MD

  Quintiles Phase One Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2007
• First Posted: September 20, 2007
• Study Start: August 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 14, 2012

Record last verified: 2012-01

Locations

US (5)