A/H5N1 Dose Ranging Study With Adjuvant Patch

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

Interventions

BIOLOGICAL

A/H5N1

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

BIOLOGICAL

A/H5N1

Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21

BIOLOGICAL

A/H5N1

Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21

BIOLOGICAL

A/H5N1

Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21

BIOLOGICAL

A/H5N1

Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21

BIOLOGICAL

A/H5N1

Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21

BIOLOGICAL

A/H5N1

High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21

BIOLOGICAL

A/H5N1

High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21

BIOLOGICAL

A/H5N1

High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

• Department of Health and Human Services

  collaborator FED

• Intercell USA, Inc.

  lead INDUSTRY

Principal Investigators

• Philip Leese, MD · Quintiles Phase One Services

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-08-31

Primary Completion

2008-06-30

Completion

2008-06-30

Countries

• United States

Study Locations