Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-31 @ 1:11 AM
Study NCT ID:
NCT02586792
Status:
COMPLETED
Last Update Posted:
2018-08-22
First Post:
2015-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
H7N9 Boost in Healthy Adults
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
Phase II, Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of a Single Intramuscular Dose of Inactivated Influenza A/H7N9 Vaccine After Priming With Inactivated Influenza A/H7N7 Vaccine
Status:
COMPLETED
Status Verified Date:
2016-04
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 study will be an open-label phase 2 clinical trial of a single dose of an inactivated H7N9 influenza vaccine (non-adjuvanted). The subjects of the study will have previously participated in DMID trial 07-0023, evaluating inactivated Influenza A/H7N7 vaccine. In the previous study healthy adults 18 to 40 years old were randomized to receive two doses, 28 days apart, of placebo or 7.5, 15, 45, or 90 ug of the influenza vaccine by IM injection in a 1:1 ratio (N=25/vaccine group and 25 in placebo group). The primary objectives are to 1) assess the safety and reactogenicity of a single dose A/H7N9 vaccine in individuals who previously received two IM doses of an A/H7N7 vaccine or are A/H7 vaccine-naïve and 2) To assess the serum hemagglutination inhibition (HAI) antibody responses against A/H7N9 approximately 28 days following receipt of a single dose of A/H7N9 vaccine in individuals who previously received two IM doses of A/H7N7 vaccine or are A/H7 vaccine-naïve.
Detailed Description:
This is a Phase II, open-label study in up to 50 males and non-pregnant females, 19 to 50 years old, inclusive, who are in good health and meet all entry criteria. The study is designed to assess the safety, reactogenicity, and immunogenicity of a single dose of a monovalent inactivated influenza A/H7N9 virus vaccine (45 mcg of HA/0.75 mL) manufactured by Sanofi Pasteur administered to healthy adults who previously received two doses of monovalent inactivated influenza A/H7N7 virus vaccine manufactured by Sanofi Pasteur or one or two doses of placebo in Protocol 07-0023. All subjects will receive a single dose of the inactivated influenza A/H7N9 vaccine delivered intramuscularly. Reactogenicity will be measured by the occurrence of solicited injection site and systemic reactions from the time of the study vaccination Day 1/Visit 01 through 8 days after the study vaccination. Unsolicited non-serious adverse events (AEs) will be collected from the time of the study vaccination through roughly 28 days after the study vaccination. Serious adverse events (SAEs) and new-onset chronic medical conditions will be collected from the time of the study vaccination through roughly 6 months after the study vaccination. Immunogenicity testing against A/H7N9 and A/H7N7 antigens will include performing hemagglutination inhibition (HAI) and neutralizing (Neut) antibody assays on serum obtained immediately prior to the study vaccination, and roughly 8 and 28 days after the study vaccination.
An additional 60 mL of venous blood will be drawn immediately prior to the study vaccination, and roughly 8 and 28 days after the study vaccination for exploratory cellular immunology assays.
The duration of this study for each subject will be roughly 6 months. The primary objectives are 1. to assess the safety and reactogenicity of a single dose monovalent inactivated influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve. 2. To assess the serum hemagglutination inhibition (HAI) antibody responses against A/H7N9 roughly 28 days following receipt of a single dose of a monovalent inactivated influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve.
The secondary objectives are 1. To assess study-vaccine related unsolicited non-serious adverse events following receipt of one dose of a monovalent inactivated influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve. 2. To assess new-onset chronic medical conditions following receipt of one dose of a monovalent inactivated influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve.3) To assess the serum HAI antibody responses against A/H7N9 at baseline and about 8 days following receipt of a single dose of a monovalent inactivated influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve. 4. To assess the serum neutralizing (Neut) antibody responses against A/H7N9 at baseline and roughly 8 and 28 days following receipt of a one dose of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve.
An additional 60 mL of venous blood will be drawn immediately prior to the study vaccination, and roughly 8 and 28 days after the study vaccination for exploratory cellular immunology assays.
The duration of this study for each subject will be roughly 6 months. The primary objectives are 1. to assess the safety and reactogenicity of a single dose monovalent inactivated influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve. 2. To assess the serum hemagglutination inhibition (HAI) antibody responses against A/H7N9 roughly 28 days following receipt of a single dose of a monovalent inactivated influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve.
The secondary objectives are 1. To assess study-vaccine related unsolicited non-serious adverse events following receipt of one dose of a monovalent inactivated influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve. 2. To assess new-onset chronic medical conditions following receipt of one dose of a monovalent inactivated influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve.3) To assess the serum HAI antibody responses against A/H7N9 at baseline and about 8 days following receipt of a single dose of a monovalent inactivated influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve. 4. To assess the serum neutralizing (Neut) antibody responses against A/H7N9 at baseline and roughly 8 and 28 days following receipt of a one dose of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve.
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?: