Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310206
Status:
COMPLETED
Last Update Posted:
2013-06-03
First Post:
2006-03-30
Brief Title:
H5N1 Vaccine Intramuscular Versus Intradermal in Healthy Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Open-Label Phase I Clinical Trial Comparing the Safety Reactogenicity and Immunogenicity of Immunization With Inactivated Influenza AH5N1 Vaccine Administered by the Intradermal or the Intramuscular Route Among Healthy Adults
Status:
COMPLETED
Status Verified Date:
2009-10
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 H5N1 flu vaccine when given by different routes of injection injection into the skin or into the muscle It will also compare how antibodies proteins produced by the bodys immune system that recognize and help fight infections and other foreign substances in the body are made after receiving the H5N1 flu vaccine Participants will include 100 healthy adults ages 18-40 years Study procedures include blood samples and completing a memory aid documenting daily oral temperature and side effects for 7 days following each vaccination Participants may be involved in the study for up to 13 months
Detailed Description:
This is a single-center randomized open-label dose-ranging phase I comparative trial of intradermal ID and intramuscular IM injection with subvirion inactivated influenza AH5N1 vaccine in healthy adults 18 to 40 years old inclusive This study is designed to investigate the safety reactogenicity and dose-related immunogenicity of an investigational inactivated influenza AH5N1 virus vaccine given by ID injection compared to IM injection The primary objectives of this study are to compare dose-related safety and reactogenicity profiles of ID and IM injection with subvirion inactivated influenza AH5N1 vaccine among healthy young adults compare the dose-related immunogenicity of subvirion inactivated influenza AH5N1 vaccine given by ID with vaccine given by IM injection among healthy young adults 1 month after receipt of the second dose of vaccine and provide information for the selection of the best dose levels for further studies The secondary objectives of this study are to evaluate dose-related immunogenicity and the percent of subjects responding approximately 1 and 7 months after the first vaccination and evaluate the dose-related safety reactogenicity and immunogenicity following receipt of a third dose of vaccine administered 6-7 months after the second dose of vaccine The study will have 2 comparison arms IM and ID and 2 dosage levels will be evaluated in each arm 4 vaccine groups total Subjects will be randomized 1111 25 subjects in each group to receive 2 doses 1 month apart of an inactivated influenza AH5N1 vaccine containing 15 mcg or 45 mcg of H5 HA by the IM route or one-fifth of the IM dose 3 mcg or 9 mcg by the ID route Subjects will maintain a memory aid recording oral temperature and systemic and local adverse events for 7 days after each inoculation Serum for immunogenicity evaluations will be obtained prior to first vaccination at Day 0 prior to second vaccination at Day 28 and on Day 56 and approximately Day 215 7 months after dose 1 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