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Cellular and Humoral Immune Response to Primary and Secondary Immunization With Subvirion H5N1 Vaccines

NCT01086566 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2016-01-01

No results posted yet for this study

Summary

The purpose of the study is to evaluate safety and compare how the body reacts to 2 different strengths of the Clade (specific type of H5N1 virus) 2 H5N1 flu vaccine when given as a single vaccination with a high dose (90 mcg) or low dose (15 mcg) to volunteers who have received at least 2 doses of the Clade 1 H5N1 vaccine, in a previous National Institute of Health study or who have never received a H5N1 vaccine (naïve). Previously vaccinated subjects (in studies 04-0063, 05-0090, 05-0127) will receive either 15 or 90 mcg of H5N1 vaccine. Multiply boosted volunteers who participated study 05-0043 and received Clade 1 and 3 vaccines, will receive the same dose (15mcg). Vaccine naïve subjects will receive 2 doses of vaccine (15 or 90 mcg) separated by 28 days. Blood samples will be collected. 115 volunteers age 18-64 may participate in study related procedures for approximately 7 months.

Conditions

Interventions

BIOLOGICAL

Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005

Inactivated monovalent subvirion H5N1 vaccine (HA of A/Indonesia/05/05) provided in unit-dose vials containing 0.5 mL of either 30 mcg/mL A/H5N1 HA or 180 mcg/mL A/H5N1 HA. Subjects will receive 1 of 2 dose levels of vaccine, 15 or 90 mcg.

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
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

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 NCT01086566 on ClinicalTrials.gov