Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00294099
Status:
COMPLETED
Last Update Posted:
2013-06-03
First Post:
2006-02-16
Brief Title:
H5 Vaccine Alone or With Aluminum Hydroxide in Elderly Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I-II Randomized Controlled Dose-Ranging Study of the Safety Reactogenicity and Immunogenicity of Intramuscular Inactivated Influenza AH5N1 Vaccine Given Alone or With Aluminum Hydroxide to 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 study is to compare how the body reacts to different strengths of the new AH5N1 flu vaccine when given with the addition of aluminum hydroxide adjuvant and provide dosing information How the bodys immune system responds to the new H5N1vaccine with aluminum hydroxide approximately 1 month following receipt of 2 doses of vaccine will also be evaluated The vaccine is given as an injection or shot in the arm Volunteer participants in this study will be 600 healthy elderly adults aged 65 years and older Participants will be randomly assigned to 4 different dosage groups of vaccine either with or without adjuvant for a total of 8 different groups Volunteers will participate in the study for 7 months Each individual will receive two vaccinations the second 28 days after the first In addition to visits for these vaccinations subjects will return to the clinic for physical evaluations and blood sample collection 6 times during the course of this study
Detailed Description:
This is a double-blind randomized controlled dose-ranging Phase I-II study in healthy ambulatory elderly adults The primary objectives are to determine the dose-related safety of subvirion-inactivated H5N1 vaccine adjuvanted with aluminum hydroxide in healthy elderly adults 65 years of age and older determine the potential for aluminum hydroxide to enhance the immune response to subvirion inactivated H5N1 vaccine in healthy elderly adults approximately 1 month following receipt of 2 doses of vaccine and provide information for the selection of the best dosage level for further studies A secondary objective is to evaluate dose-related immunogenicity and the percent of subjects responding approximately 1 and 7 months after the first vaccination Approximately 600 elderly subjects are planned for enrollment Subjects will be screened for health status by history and targeted physical examination Subjects who meet the entry criteria for the study will be randomized into 8 groups to receive 2 doses of nonadjuvanted or aluminum hydroxide-adjuvanted influenza AH5N1 vaccine containing 375 75 15 or 45 micrograms of hemagglutinin HA by intramuscular injection The first vaccination will occur on Day 0 Symptoms and signs will be assessed in the clinic for at least 15 minutes after inoculation and subjects will maintain a memory aid to record oral temperature and systemic and local adverse events AEs for 7 days after each immunization Subjects will be encouraged to take their temperature around the same time each day All subjects will return to the clinic on Days 2 and 8 after each vaccination for assessment of AEs and concomitant medications as well as a targeted physical examination if indicated Memory aids will be reviewed at each visit At approximately Day 28 after the first vaccination subjects will return to the clinic for blood sample collection and safety follow-up followed by a second vaccination Safety follow-up will be identical to that performed after the first vaccination Approximately 56 days after first immunization or about 28 days after the second vaccination subjects will return to the clinic for immunogenicity blood sample collection AE and concomitant medication assessments and targeted physical examinations if indicated At approximately Day 208 7 months after the first vaccination subjects will return to the clinic for a final immunogenicity blood sample collection and for follow-up which includes a targeted physical examination if indicated The duration of the study treatment for each subject will be about 7 months The primary study endpoints include AE or serious adverse event SAE information proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 140 against influenza AH5N1 virus 28 days after receipt of the second dose of vaccine proportion of subjects in each dose group achieving a serum hemagglutination inhibition HAI antibody titer of greater than or equal to 140 against the influenza AH5N1 virus 28 days after receipt of the second dose of vaccine geometric mean titer GMT and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 28 days after receipt of the second dose of vaccine and GMT and frequency of 4-fold or greater increases in serum HAI antibody titers in each group 28 days after receipt of the second dose of vaccine The secondary endpoints include GMT and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine GMT and frequency of 4-fold or greater increases i
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None