Phase I Study of a Vaccine for Severe Acute Respiratory Syndrome (SARS)

NCT00099463 | Completed Phase 1

• 2 other identifiers: 05005605-I-0056
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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)

Conditions

Healthy

Keywords

Coronavirus; Healthy; Immunity; Preventive; Virus; Healthy Volunteer; HV

Interventions

Blood Test PROCEDURE

Urine Test PROCEDURE

Physical Exam PROCEDURE

Vaccine DRUG

VRC-SRSDNA015-00-VP DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A participant must meet all of the following criteria:
• to 50 years old.
• Available for clinical follow-up through Week 32 of the study.
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly.
• Able and willing to complete the informed consent process.
• Willing to receive HIV test results and wiling to abide by NIH guidelines for partner notification of positive HIV results.
• Willing to donate blood for sample storage to be used for future research.
• In good general health without clinically significant medical history and has satisfactorily completed screening.
• Physical examination and laboratory results without clinically significant findings within the 28 days prior to enrollment.
• Laboratory Criteria within 28 Days prior to Enrollment:
• Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men.
• WBC = 3,300-12,000 cells/mm(3).
• Absolute neutrophil count (ANC) within institutional normal range.
• Total lymphocyte count greater than or equal to 800 cells/mm(3).

You may not qualify if:

• A volunteer will be excluded if one or more of the following conditions apply:
• Women:
• Woman who is breast-feeding or planning to become pregnant during the 32 weeks of study participation.
• Volunteer has received any of the following substances:
• Immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis).
• Blood products within 120 days prior to HIV screening.
• Immunoglobulin within 60 days prior to HIV screening.
• Investigational research agents within 30 days prior to initial study vaccine administration.
• Live attenuated vaccines within 30 days prior to initial study vaccine administration.
• Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration.
• Current anti-TB prophylaxis or therapy.
• Volunteer has a history of any of the following clinically significant conditions:
• Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain.
• Autoimmune disease or immunodeficiency.
• Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Ksiazek TG, Erdman D, Goldsmith CS, Zaki SR, Peret T, Emery S, Tong S, Urbani C, Comer JA, Lim W, Rollin PE, Dowell SF, Ling AE, Humphrey CD, Shieh WJ, Guarner J, Paddock CD, Rota P, Fields B, DeRisi J, Yang JY, Cox N, Hughes JM, LeDuc JW, Bellini WJ, Anderson LJ; SARS Working Group. A novel coronavirus associated with severe acute respiratory syndrome. N Engl J Med. 2003 May 15;348(20):1953-66. doi: 10.1056/NEJMoa030781. Epub 2003 Apr 10.

  PMID: 12690092 BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections; Virus Diseases

Interventions

Hematologic Tests; Urinalysis; Restraint, Physical; Vaccines

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Clinical Chemistry Tests; Diagnostic Techniques, Urological; Behavior Control; Therapeutics; Immobilization; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 14, 2004
• First Posted: December 15, 2004
• Study Start: December 9, 2004
• Study Completion: August 22, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-08-22

Locations

US (1)