Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489931
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2007-06-20
Brief Title:
Phase I Open-Label Study of Recombinant DNA Plasmid Vaccine VRC-AVIDNA036-00-VP Encoding for Influenza Virus H5 Hemagglutinin Protein Given Intradermally
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Open-Label Study of the Safety and Immunogenicity of a Recombinant DNA Plasmid Vaccine VRC-AVIDNA036-00-VP Encoding for the Influenza Virus H5 Hemagglutinin Protein Administered Intradermally in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2009-04-15
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:
This study will evaluate the safety and effectiveness of a vaccine to prevent avian influenza bird flu About 25 to 50 million cases of influenza occur a year in the US leading to 150000 hospitalizations and 30000 to 40000 deaths Globally a pandemic influenza may be 1 billion flu cases with 3 to 5 million cases of severe illness and up to half a million deaths annually There is potential threat of a pandemic from emerging virus strains for which the population has little or no preexisting immunity Avian influenza A H5N1 viruses causing serious disease have emerged recently affecting domestic and wild bird populations
Patients ages 18 to 60 who are in good health and not pregnant or breast feeding may be eligible for this study The study will be done at the NIH Clinical Center by staff of the Vaccine Research Center It will last about 32 weeks for each person A traditional needle or a needle-free device called Biojector 2000 will be used Intramuscular in the muscle and subcutaneous in fat below the skin delivery of vaccine via Biojector is cleared for use by the Food and Drug Administration and is not considered investigational Intradermal in the skin delivery of vaccine by Biojector in this study is deemed investigational but has been evaluated in humans before and found safe and well tolerated in other trials
There will be about 10 clinic visits in this study and it is important to stay on schedule Visits are about 2 hours though on injection days visits are about 4 hours Injections are given on day 0 and at weeks 4 and 8 The vaccine is given by injections in the skin on the upper arms Clinic staff will observe patients for 30 minutes after each vaccination One to 2 days after the first injection there will be a clinic visit One to 3 days after the second and third injections patients need to telephone clinic staff to report on how they are doing Patients will complete a diary card at home recording temperature and symptoms and looking at the injection site daily for 5 days Patients should report any side effects to one of the study physicians or nurses as soon as possible They will return to the clinic 2 weeks after each injection A needle-free system uses the pressure of carbon dioxide instead of a needle to inject the vaccine into the skin Discomfort can result from either the needle-free device or the needle There may be stinging pain soreness swelling bruising or a small cut in the skin
Patients ages 18 to 60 who are in good health and not pregnant or breast feeding may be eligible for this study The study will be done at the NIH Clinical Center by staff of the Vaccine Research Center It will last about 32 weeks for each person A traditional needle or a needle-free device called Biojector 2000 will be used Intramuscular in the muscle and subcutaneous in fat below the skin delivery of vaccine via Biojector is cleared for use by the Food and Drug Administration and is not considered investigational Intradermal in the skin delivery of vaccine by Biojector in this study is deemed investigational but has been evaluated in humans before and found safe and well tolerated in other trials
There will be about 10 clinic visits in this study and it is important to stay on schedule Visits are about 2 hours though on injection days visits are about 4 hours Injections are given on day 0 and at weeks 4 and 8 The vaccine is given by injections in the skin on the upper arms Clinic staff will observe patients for 30 minutes after each vaccination One to 2 days after the first injection there will be a clinic visit One to 3 days after the second and third injections patients need to telephone clinic staff to report on how they are doing Patients will complete a diary card at home recording temperature and symptoms and looking at the injection site daily for 5 days Patients should report any side effects to one of the study physicians or nurses as soon as possible They will return to the clinic 2 weeks after each injection A needle-free system uses the pressure of carbon dioxide instead of a needle to inject the vaccine into the skin Discomfort can result from either the needle-free device or the needle There may be stinging pain soreness swelling bruising or a small cut in the skin
Detailed Description:
Study Design This is a Phase I study to evaluate safety tolerability and immunogenicity of a recombinant DNA vaccine against the influenza virus H5 hemagglutinin by intradermal ID delivery The hypothesis is that this vaccine will be safe for human administration by ID delivery by either needlesyringe or Biojector and will elicit antibody and T cell responses against the H5 protein Primary objectives are to evaluate safety and tolerability of the vaccine at 500 micrograms ID administered by needle and syringe or by Biojector and at 1 mg ID administered by Biojector as two injections in the same or in different arms in healthy adults Secondary and exploratory objectives are related to immunogenicity
Product Description The vaccine is composed of a single closed-circular DNA plasmid that encodes the H5 protein with a CMVR promoter Vaccine vials will be supplied at 4 mgmL Each injection will be 125 microliters 500 micrograms administered ID over the deltoid muscle using the Biojector Registered Trademark 2000 Needle-Free Injection Management System Biojector or needle and syringe
Subjects A total of 40 healthy adults ages 18-60 years will be enrolled
Study Plan Subjects will be simultaneously randomized at a ratio of 1111 into one of four groups as shown in the schema The protocol requires ten clinic visits and three telephone follow-up contacts
Study Duration Each participant will complete 32 weeks of clinical follow up
Study Endpoints The primary endpoint is safety and tolerability of the regimen The secondary immunogenicity endpoint is H5-specific antibody as measured by hemagglutination inhibition HAI assay and H5 neutralizing antibody assay at Study Week 12 Other immunogenicity assays at timepoints throughout the study may also be completed as exploratory evaluations
Product Description The vaccine is composed of a single closed-circular DNA plasmid that encodes the H5 protein with a CMVR promoter Vaccine vials will be supplied at 4 mgmL Each injection will be 125 microliters 500 micrograms administered ID over the deltoid muscle using the Biojector Registered Trademark 2000 Needle-Free Injection Management System Biojector or needle and syringe
Subjects A total of 40 healthy adults ages 18-60 years will be enrolled
Study Plan Subjects will be simultaneously randomized at a ratio of 1111 into one of four groups as shown in the schema The protocol requires ten clinic visits and three telephone follow-up contacts
Study Duration Each participant will complete 32 weeks of clinical follow up
Study Endpoints The primary endpoint is safety and tolerability of the regimen The secondary immunogenicity endpoint is H5-specific antibody as measured by hemagglutination inhibition HAI assay and H5 neutralizing antibody assay at Study Week 12 Other immunogenicity assays at timepoints throughout the study may also be completed as exploratory evaluations
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-I-0172 | None | None | None |