Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-25 @ 2:47 PM
Study NCT ID:
NCT00230750
Status:
COMPLETED
Last Update Posted:
2013-08-23
First Post:
2005-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inactivated Influenza A/H5N1 Vaccine in the Elderly
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
A Randomized, Double-Blinded, Placebo-Controlled Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Elderly Adults
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to compare how the body reacts to different strengths of a new H5N1 flu vaccine. Researchers will also look at how antibodies are made after subjects receive the H5N1 flu vaccine. Participants will include at least 240 healthy males and females, aged 65 and older. The vaccine is given as an injection or shot in the arm. Subjects will receive 3 doses of vaccine at Day 0, Month 1 and Month 6. There are 2 different doses of the new H5N1 vaccine that will be given in this study. There is also a chance that a subject may receive a placebo (dummy) injection of saltwater instead of the flu vaccine. Study procedures will include physical exams and blood sample collections. Additionally, participants will complete a memory aid card to document daily temperatures and any symptoms experienced for a week after receiving vaccine. The length of participation in this study will be approximately 14 months.
Detailed Description:
The goals of this study are to compare the safety, reactogenicity, and immunogenicity of two dose levels of monovalent subvirion influenza A/H5N1 virus vaccine administered by injection to healthy elderly adults aged 65 years and older. Researchers hypothesize that a dose of either 45 micrograms or 90 micrograms of H5N1 vaccine will be well tolerated and result in acceptable immunogenicity. Thus, the primary goal of this study is to determine the lowest dose level of H5N1 that will result in an acceptable proportion of subjects achieving a potentially protective postvaccination antibody titer combined with an acceptable safety profile. The study will enroll at least 240 (and up to 260) healthy ambulatory male and female subjects aged 65 and older, in the United States, may be enrolled. Three doses of the vaccine at 2 dose levels (45 micrograms or 90 micrograms) or saline placebo will be administered 28 days apart for the first two doses. The third dose will be given six months after the first dose. Serum hemagglutination inhibition (HAI) and neutralizing antibody titers will be assessed approximately 1 month after receipt of each dose and 6 month after first and third doses. The primary objectives of the study are: to determine the dose-related safety of intramuscular (IM) subvirion inactivated H5N1 vaccine in healthy elderly adults (65 years of age and older); to determine the immunogenicity of IM subvirion inactivated H5N1 vaccine approximately 1 month following receipt of 2 doses of vaccine; and to provide information for the selection of the best dose level(s) for further studies. The secondary objective is to determine the immunogenicity of IM subvirion inactivated H5N1 vaccine approximately 1 and 6 months following receipt of first and third doses of the vaccine. The primary endpoints include: adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments); proportion of subjects achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of second dose of vaccine (approximately Day 56); geometric mean titer (GMT) and the frequency of 4-fold or greater increases in neutralizing antibody titers 28 days after receipt of second dose of vaccine (approximately Day 56). The secondary endpoints include: development of serum antibody responses against antigenically drifted variants of H5N1 influenza virus and geometric mean titer and the frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) and neutralizing antibody titer 1 and 6 months after receipt of first and third dose of vaccine. The duration of the study will be approximately 15 months (approximately 14 months for each subject). This study is linked to DMID protocols 07-0022 and 05-0006.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: