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Phase I, double-blinded, placebo-controlled dosage escalation study of the safety and immunogenicity of adjuvanted and non-adjuvanted inactivated SARS coronavirus (SARS-CoV) vaccine administered by the intramuscular route.

Trial Profile

Phase I, double-blinded, placebo-controlled dosage escalation study of the safety and immunogenicity of adjuvanted and non-adjuvanted inactivated SARS coronavirus (SARS-CoV) vaccine administered by the intramuscular route.

Status: Withdrawn prior to enrolment
Phase of Trial: Phase I

Latest Information Update: 30 Nov 2012

At a glance

  • Drugs Aluminium hydroxide; Coronavirus vaccine
  • Indications Severe acute respiratory syndrome
  • Focus Adverse reactions; Pharmacodynamics
  • Most Recent Events

    • 05 Aug 2011 Status changed from not yet recruiting to withdrawn prior to recruitment as reported by ClinicalTrials.gov.
    • 12 May 2011 Planned end date changed from 1 Jan 2010 to 1 Jan 2012 as reported by ClinicalTrials.gov.
    • 26 Nov 2008 Checked against ClinicalTrials.gov record NCT00533741.

Trial Overview

Comments

This trial is entitled "Phase I, double-blinded, placebo-controlled dosage escalation study of the safety and immunogenicity of adjuvanted and non-adjuvanted inactivated SARS coronavirus (SARS-CoV) vaccine administered by the intramuscular route". The primary outcomes are frequency and severity of solicited injection site and systemic signs and symptoms and unsolicited adverse events/serious adverse events (SAEs) at 1 month after receipt of the first and second doses of vaccine, frequency of significant increases in serum antibody to CoV S protein in enzyme-linked immunosorbent assay and in neutralization tests, and increases in geometric mean titers in sera collected 1 and 5 months after the booster dose of vaccine, versus sera collected before the 1st vaccination at screening, 1 and 5 months after the booster dose of vaccine and frequency and description of SAEs at 5 months after receipt of the booster dose and frequency and description of severe adverse events at 5 months after receipt of the booster dose of vaccine.

Primary Endpoints

Antibody levels (Assessed at 1 and 5 months after the booster dose of vaccine.)

Other Endpoints

Geometric mean antibody titre
Immunological response rate

Diseases Treated

Indication Qualifiers Patient Segments
Severe acute respiratory syndrome prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 72

    Actual: 0

  • Sex male & female
  • Age Group 18-40 years; adult

Patient Inclusion Criteria

Able to understand and communicate in written and spoken English. - Judged to be able to provide informed consent and has signed informed consent form prior to study participation. - Male or female between 18 and 40 years of age. - Females of childbearing potential agree to practice adequate contraception for the entire study period. - Good general health as confirmed by medical history, history-directed physical examination, and laboratory assessments within normal ranges established by Baylor College of Medicine. - Availability for follow-up for six months after the first vaccination. - Willing and able to comply with protocol requirements.

Patient Exclusion Criteria

Clinically significant medical disorder found by medical history or physical exam. - History of anaphylaxis or other significant adverse event following immunization. - History of or planned exposure to small mammalian animals that are from Asia, or were previously housed with Asian counterparts. - Pregnant or lactating female. - Acute illness (cough, congestion, malaise, diarrhea, feverishness and/or oral temperature > 99.5 degrees Fahrenheit, etc.) within a week of planned vaccination. - Use of an immunosuppressive or immunomodulatory drug such as greater than 5 mg/day of prednisone orally, or greater than 800 mcg/day of inhaled beclomethasone for 2 or more consecutive weeks within 3 months prior to the first vaccination. - History of or current substance abuse, including alcohol (e.g., greater than or equal to 4 six-packs of beer or equivalent per week regularly). - History of receiving blood or blood products in the previous three months, or anticipated over the six month study period. - Vaccination with a live vaccine within 30 days of study vaccination, or a non-replicating, inactivated or subunit vaccine within 14 days of study vaccination, or planned during the study. - Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HbsAg). - Positive serology for severe acute respiratory disease (SARS) S protein if testing is done. - Use of any investigational or unregistered drug or vaccine within 30 days before the first study vaccination, or planned use during the study. - Autoimmune disease (e.g., lupus, rheumatoid arthritis), malignancy or tumor. - Bleeding disorder by history, or thrombocytopenia. - Diagnosis of schizophrenia, bipolar disease or other major psychiatric disorder. - Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others. - Are receiving psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, loxapine, thioridazine, molindone, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate). Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study. - Plans to enroll in another study before study completion (six months).

Trial Details

Identifiers

Identifier Owner
NCT00533741 ClinicalTrials.gov: US National Institutes of Health
07-0021 -
N01AI30039C -

Trial Dates

  • Initiation Dates

    Actual : 01 Jan 2012

  • Primary Completion Dates

    Planned : 01 Jan 2012

  • End Dates

    Planned : 31 Jan 2012

    Actual : 31 Jan 2012

Other Details

  • Design double-blind; parallel; prospective; randomised
  • Phase of Trial Phase I
  • Location USA
  • Focus Adverse reactions; Pharmacodynamics

Interventions

Drugs Route Formulation
Aluminium hydroxide
-
-
Coronavirus vaccine
-
-

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Couch RB
(713) 798-4474
show details
-
-
Johnson R National Institute of Allergy and Infectious Diseases
-

Centres

Centre Name Location Trial Centre Country
Baylor College of Medicine Houston, Texas USA
National Institute of Allergy and Infectious Diseases
-
-

Trial History

Event Date Event Type Comment
30 Nov 2012 Other trial event Last checked against ClinicalTrials.gov record. Updated 07 Dec 2012
05 Aug 2011 Status change - withdrawn prior to enrolment Status changed from not yet recruiting to withdrawn prior to recruitment as reported by ClinicalTrials.gov. Updated 11 Aug 2011
12 May 2011 Completion date Planned end date changed from 1 Jan 2010 to 1 Jan 2012 as reported by ClinicalTrials.gov. Updated 16 May 2011
26 Nov 2008 Background audit Checked against ClinicalTrials.gov record NCT00533741. Updated 02 Dec 2008
28 Aug 2008 Other trial event Primary outcome changed as reported by ClinicalTrials.gov. Updated 02 Sep 2008
17 Aug 2008 Other trial event Planned number of patients changed from 90 to 72 as reported by ClinicalTrials.gov. Updated 02 Sep 2008
17 Apr 2008 Other trial event Primary outcome added as reported by ClinicalTrials.gov. Updated 21 Nov 2008
10 Apr 2008 Completion date The expected completion date for this trial is now 1 Jan 2010, according to clinicaltrials.gov. Updated 15 Apr 2008
06 Oct 2007 New trial record New trial record. Updated 06 Oct 2007

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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