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Immune Responses to H5N1 Vaccine With and Without AS03 Adjuvant

NCT01578317 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2019-02-26

Study results available
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Summary

Background:

\- Adjuvants are substances included in vaccines that stimulate the immune system and increase the body's response to the vaccine. The AS03 adjuvant is used in seasonal flu vaccines in Europe. However, it has not been fully tested in the United States. Researchers want to test the immune responses of people who receive a bird flu vaccine with or without AS03 to better understand how the adjuvant works. This information may help develop better flu vaccines.

Objectives:

\- To compare the healthy immune system responses to bird flu vaccine with or without the AS03 adjuvant.

Eligibility:

\- Healthy volunteers between 18 and 45 years of age.

Design:

* Participants will be screened with a physical exam and medical history.
* Participants will be assigned to one of two groups. Each group will have an initial vaccine, followed by a booster vaccine 21 days later. Both vaccinations will use the same type of vaccine. One group will have the vaccine with AS03; the other group will have the vaccine without it.
* All participants will have two 36-hour inpatient stays to receive the vaccine. Each stay will involve the vaccination, followed by regular and frequent blood draws. Participants will be monitored for any signs or symptoms that may be caused by the vaccine.
* Additional blood samples will be collected 7, 28, 42, and 100 days after the initial vaccination.

Conditions

Interventions

BIOLOGICAL

H5N1 vaccine plus AS03 adjuvant

H5N1 influenza vaccine with AS03 at the 3.75 mcg dose level given 21 days apart.

BIOLOGICAL

H5N1 vaccine without adjuvant

H5N1 influenza vaccine non- adjuvanted form at the 3.75 mcg dose level given 21 days apart.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • John S Tsang, Ph.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-03-20
Primary Completion
2016-01-31
Completion
2016-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT01578317 on ClinicalTrials.gov