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A phase I study of the safety and immunogenicity of a SARS recombinant DNA plasmid vaccine, VRC-SRSDNA015-00-VP, in healthy adult volunteers

Trial Profile

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
Phase of Trial: Phase I

Latest Information Update: 01 Feb 2017

At a glance

  • Drugs Coronavirus vaccine; VRC SRSDNA015 00 VP
  • Indications Severe acute respiratory syndrome
  • Focus Adverse reactions; Pharmacodynamics; Therapeutic Use
  • Most Recent Events

    • 25 Nov 2008 Results published in Vaccine, reported in a Vical media release.
    • 23 Aug 2007 Status changed from in progress to completed.
    • 11 Nov 2005 New trial record.

Trial Overview

Purpose

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.

Other Endpoints

CD4+ cell count
CD8+ cell count
Immunological response
Neutralising antibody levels

Diseases Treated

Indication Qualifiers Patient Segments
Severe acute respiratory syndrome treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 10

  • Sex male & female
  • Age Group 18-50 years

Patient Inclusion Criteria

age 18-50 years; 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 enrolment process; complete an Assessment of Understanding prior to enrolment and verbalise 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 National Institutes of Health 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 enrolment; laboratory criteria within 28 Days prior to enrolment: haemoglobin greater than or equal to 11.5 g/dL for women and greater than or equal to 13.5 g/dL for men, white blood cells 3,300-12,000 cells/mm3, absolute neutrophil count (ANC) within institutional normal range, total lymphocyte count greater than or equal to 800 cells/mm3, platelets within institutional normal limits, alanine aminotransferase less than or equal to upper limit of normal, serum creatinine less than or equal to upper limit of normal, normal urinalysis defined as negative glucose, negative or trace protein, and no clinically significant blood in the urine, negative FDA-approved HIV blood test, negative hepatitis B surface antigen, negative anti-HCV (hepatitis C virus antibody) and negative HCV PCR

Patient Exclusion Criteria

women who are 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, hospitalisation or intubation during the past two years or that requires the use of oral or intravenous corticosteroids, diabetes mellitus (type I or II), with the exception of gestational diabetes, history of thyroidectomy or thyroid disease that required medication within the past 12 months, serious angioedema episodes within the previous 3 years or requiring medication in the previous two years, hypertension that is not well controlled by medication or is more than 145/95mm Hg at enrolment, bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws, malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study, seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years, asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen, psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrolment, any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgement of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent, allergic reaction to aminoglycoside antibiotics

Trial Details

Identifiers

Identifier Owner
NCT00099463 ClinicalTrials.gov: US National Institutes of Health
050056 -
05I0056 -

Organisations

  • Affiliations Vical

Trial Dates

  • Initiation Dates

    Actual : 09 Dec 2004

  • End Dates

    Planned : 01 Aug 2007

    Actual : 22 Aug 2007

Other Details

  • Design prospective
  • Phase of Trial Phase I
  • Location USA
  • Focus Adverse reactions; Pharmacodynamics; Therapeutic Use

Interventions

Drugs Route Formulation
Coronavirus vaccine
-
-
VRC SRSDNA015 00 VP
-
-

Procedure: Blood Test

Procedure: Urine Test

Procedure: Physical Exam

Drug: Vaccine

Drug: VRC-SRSDNA015-00-VP

Trial Centres

Centres

Centre Name Location Trial Centre Country
National Institute of Allergy and Infectious Diseases Bethesda, Maryland USA
National Institutes of Health Clinical Center
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States, 20892
show details
Bethesda, Maryland USA
Vical San Diego, California USA

Trial History

Event Date Event Type Comment
01 Feb 2017 Other trial event Last checked against ClinicalTrials.gov record. Updated 01 Feb 2017
25 Nov 2008 Other trial event Results published in Vaccine, reported in a Vical media release. Updated 22 Dec 2008
23 Aug 2007 Status change - completed Status changed from in progress to completed. Updated 18 Sep 2007
11 Nov 2005 New trial record New trial record. Updated 11 Nov 2005
13 Dec 2004 Other trial event Trial initiation, reported in a National Institutes of Health media release. Updated 22 Dec 2008

References

  1. NIH Clinical Center Clinical Research Studies. Government 2005;.

    PubMed | CrossRef Fulltext
  2. Vical Incorporated. SARS Vaccine Achieves Neutralizing Responses in First U.S. Human Trial. Media-Rel 2008;.

    Media Release
  3. National Institute of Allergy and Infectious Diseases. First U.S. SARS Vaccine Trial Opens at NIH. Media-Rel 2004;.

    Media Release
  4. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  5. Vical Incorporated. Vical Announces Fourth-Quarter and Year-End 2004 Financial Results. Media-Rel 2005;.

    Media Release
  6. Vical Incorporated. Vical Reports 2007 Financial Results and Progress in Product Development Programs. Media-Rel 2008;.

    Media Release
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