Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00382980
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2006-09-28
Brief Title:
Dose-Escalating Trial Using Vero Cell-culture Derived H5N1 - Aluminum in 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 Randomized Double-Blind Placebo-Controlled Dose-Ranging Clinical Trial of the Safety Reactogenicity and Immunogenicity of Intramuscular Immunization With Inactivated Vero Cell-Culture Derived Influenza AH5N1 Vaccine Given Alone or With Aluminum Hydroxide to Healthy Young 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 an experimental cell culture-grown whole virus AH5N1 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
Detailed Description:
This is a phase I randomized double-blind placebo-controlled dose-ranging clinical trial of the safety reactogenicity and immunogenicity of intramuscular immunization with inactivated Vero cell-culture derived influenza AH5N1 vaccine given alone or with aluminum hydroxide to healthy young adults The primary objectives are to determine the dose-related safety of an inactivated cell-culture grown whole virus influenza AH5N1 vaccine with or without aluminum hydroxide adjuvant in healthy adults to determine the potential for aluminum hydroxide to enhance the immune response to inactivated whole virus H5N1 vaccine in healthy adults approximately 1 month following receipt of 2 doses of vaccine and to provide information for the selection of the best dosage level for further studies The secondary objective is to evaluate dose-related immunogenicity and the percent of subjects responding approximately 1 and 7 months after the first vaccination The primary endpoints are adverse event AE or serious adverse event SAE information solicited in the clinic and via memory aids concomitant medications periodic targeted physical assessment and laboratory safety evaluations in a subset of subjects proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 40 against the influenza AH5N1 virus 28 days after receipt of the second dose of vaccine approximately Day 56 proportion of subjects in each dose group achieving a serum hemagglutination inhibition HAI antibody titer of greater than or equal to 40 against the influenza AH5N1 virus 28 days after receipt of the second dose of vaccine approximately Day 56 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 approximately Day 56 The secondary endpoints are 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 and GMT and frequency of 4-fold or greater increases in serum HAI antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine Approximately 300 healthy adults 18-40 years old inclusive will be enrolled at up to 5 sites in the United States for up to 9 months including the screening period Two doses of vaccine or placebo will be injected into the deltoid muscle approximately 28 days apart The study will be conducted in 2 stages During Stage 1 90 subjects will be randomized to receive saline placebo or 75 micrograms with or without aluminum hydroxide 15 micrograms with or without aluminum hydroxide or 45 micrograms without aluminum hydroxide 6 groups N15 per group Blood for safety evaluations will be obtained from all subjects in the Stage 1 cohort at screening and before and 1 week after each vaccination Subjects in Stage 1 will receive their second vaccinations following review of available clinical and laboratory safety data by the Safety Monitoring Committee SMC If no dose-limiting toxicity or safety-related issues are noted during the week after administration of the first dose of vaccine during Stage 1 based on review of clinical and laboratory safety data by the SMC then Stage 1 subjects will receive a second vaccination A complete Stage 1 safety report will be reviewed by the SMC prior to the enrollment of the 210 additional subjects in Stage 2 N50 per formulation group total Sera for immune assessment of antigen-specific immune responses will be collected from all subjects at baseline Day 0 1 month after each vaccine dose and 6 months after the second vaccine dose This study is linked to DMID protocol 07-0022
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