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Dose-Escalating Trial Using Vero Cell-culture Derived H5N1 +/- Aluminum in Adults

NCT00382980 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2010-08-27

No results posted yet for this study

Summary

The purpose of this research study is to compare how the body reacts to different strengths of an experimental cell culture-grown whole virus A/H5N1 flu vaccine when given with or without the addition of aluminum hydroxide adjuvant. Researchers will also look at how much antibody is made to the influenza virus hemagglutinin (HA) after subjects receive the H5N1 vaccine. Three hundred healthy adults aged 18-40 years will participate for approximately 9 months, which includes screening. Participants will receive 2 doses of vaccine or placebo injected 28 days apart. Participants will have blood samples taken up to 7 times and have 8 scheduled study visits.

Conditions

Interventions

BIOLOGICAL

Aluminum hydroxide

Adjuvant administered with A/H5N1 vaccine dosages 7.5 mcg and 15 mcg.

BIOLOGICAL

Inactivated Vero cell based whole virus influenza A/H5N1

Inactivated Vero cell-grown, whole virus, influenza A/H5N1 vaccine at dosages 7.5 mcg and 15 mcg of hemagglutinin (HA) per 0.5 mL, each dosage with and without aluminum hydroxide adjuvant; 45 mcg HA/0.5 mL without adjuvant.

DRUG

Placebo

Saline injected into the deltoid muscle. 2 identical dosages will be given approximately 28 days apart.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00382980 on ClinicalTrials.gov