Phase I Study of a Vaccine for Severe Acute Respiratory Syndrome (SARS)
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 person's 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)
Procedure: Blood Test
Procedure: Urine Test
Procedure: Physical Exam
|Study Design:||Primary Purpose: Treatment|
|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|
|Study Start Date:||December 2004|
|Estimated Study Completion Date:||August 2007|
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 mg/mL. 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.
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|