Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099463
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-12-14
Brief Title:
Phase I Study of a Vaccine for Severe Acute Respiratory Syndrome SARS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Study of the Safety and Immunogenicity of a SARS Recombinant DNA Plasmid Vaccine VRC-SRSDNA015-00-VP in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2007-08-22
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 test whether an experimental vaccine to protect against severe acute respiratory syndrome SARS is safe causes any side effects and causes an immune response SARS affects the respiratory system usually starting with fever and muscle aches Patients may get a dry cough and have difficulty breathing Infection may be mild but it can lead to death
Vaccines contain substances from an infectious agent such as a virus that when injected into a persons body stimulates production of antibodies that create resistance or immunity to that agent The vaccine in this study contains genetic material DNA that codes for a protein found in the virus that causes SARS Injected into a muscle it instructs the body to make a small amount of a SARS protein The vaccine is made from just one small part of the code for one SARS protein a person cannot get SARS from the vaccine
Normal volunteers between 18 and 50 years of age who are in general good health may be eligible for this 32-week study Candidates are screened with a physical examination and blood and urine tests
Participants have nine clinic visits during the study They receive three vaccine injections given with a system called the Bioinjector 2000 Registered Trademark which delivers the vaccine through the skin without the use of a needle Following each injection participants take home a diary card on which they record their temperature and any vaccine side effects daily for 5 days Participants must immediately report any symptoms to a study physician and if necessary go to the clinic for an examination Participants have the following tests and procedures
Vaccine injections study day 0 around week 4 and around week 8 with at least 21 days between injections
Medical history and if needed physical examination study day 0 and weeks 2 4 6 8 10 12 24 and 32
Check of vital signs and weight study day 0 and weeks 2 4 6 8 10 12 24 and 32
Lymph node examination day 0 and weeks 2 4 6 8 10 and 12
Blood draw study day 0 and weeks 2 4 6 8 10 12 24 and 32
Pregnancy test for women day 0 and weeks 4 8 and 32
Urine sample day 0 and weeks 2 4 6 8 10
Vaccines contain substances from an infectious agent such as a virus that when injected into a persons body stimulates production of antibodies that create resistance or immunity to that agent The vaccine in this study contains genetic material DNA that codes for a protein found in the virus that causes SARS Injected into a muscle it instructs the body to make a small amount of a SARS protein The vaccine is made from just one small part of the code for one SARS protein a person cannot get SARS from the vaccine
Normal volunteers between 18 and 50 years of age who are in general good health may be eligible for this 32-week study Candidates are screened with a physical examination and blood and urine tests
Participants have nine clinic visits during the study They receive three vaccine injections given with a system called the Bioinjector 2000 Registered Trademark which delivers the vaccine through the skin without the use of a needle Following each injection participants take home a diary card on which they record their temperature and any vaccine side effects daily for 5 days Participants must immediately report any symptoms to a study physician and if necessary go to the clinic for an examination Participants have the following tests and procedures
Vaccine injections study day 0 around week 4 and around week 8 with at least 21 days between injections
Medical history and if needed physical examination study day 0 and weeks 2 4 6 8 10 12 24 and 32
Check of vital signs and weight study day 0 and weeks 2 4 6 8 10 12 24 and 32
Lymph node examination day 0 and weeks 2 4 6 8 10 and 12
Blood draw study day 0 and weeks 2 4 6 8 10 12 24 and 32
Pregnancy test for women day 0 and weeks 4 8 and 32
Urine sample day 0 and weeks 2 4 6 8 10
Detailed Description:
Study Design This is a Phase I open label study to evaluate safety tolerability and immune response of a recombinant DNA vaccine VRC-SRSDNA015-00-VP The hypothesis is that this regimen will be safe for human administration and elicit immune responses to the SARS coronavirus CoV spike S protein The primary objective is to evaluate the safety and tolerability in humans of the investigational vaccine Secondary and exploratory objectives are related to the immunogenicity of the study vaccine
Product Description VRC-SRSDNA015-00-VP is composed of a single closed circular DNA plasmid that is based on the S protein of SARS-CoV Vaccine vials will be supplied at 4 mgmL Each DNA vaccination will be 1 mL of vaccine administered intramuscularly in deltoid muscle using the Biojector 2000 Needle-Free Injection Management System
Subjects Healthy adult volunteers 18 to 50 years old will be enrolled
Study Plan Ten volunteers will be enrolled and receive 3 injections on the schedule shown in the schema The protocol requires nine clinic visits and three telephone follow-up contacts
Study Duration 32 weeks clinical follow-up for each participant
Study Endpoints The primary endpoint is safety of the regimen secondary immunogenicity endpoints are an intracellular cytokine staining ICS assay for SARS specific T cell responses and an assay for antibody-dependent enhancement of virus uptake The principal timepoints for ICS are Week 0 baseline and Weeks 6 8 10 and 12 ICS at other study timepoints as well as other immunogenicity assays through Week 32 will be completed as exploratory evaluations
Product Description VRC-SRSDNA015-00-VP is composed of a single closed circular DNA plasmid that is based on the S protein of SARS-CoV Vaccine vials will be supplied at 4 mgmL Each DNA vaccination will be 1 mL of vaccine administered intramuscularly in deltoid muscle using the Biojector 2000 Needle-Free Injection Management System
Subjects Healthy adult volunteers 18 to 50 years old will be enrolled
Study Plan Ten volunteers will be enrolled and receive 3 injections on the schedule shown in the schema The protocol requires nine clinic visits and three telephone follow-up contacts
Study Duration 32 weeks clinical follow-up for each participant
Study Endpoints The primary endpoint is safety of the regimen secondary immunogenicity endpoints are an intracellular cytokine staining ICS assay for SARS specific T cell responses and an assay for antibody-dependent enhancement of virus uptake The principal timepoints for ICS are Week 0 baseline and Weeks 6 8 10 and 12 ICS at other study timepoints as well as other immunogenicity assays through Week 32 will 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 |
|---|---|---|---|
| 05-I-0056 | None | None | None |