A phase I study of the safety and immunogenicity of a SARS recombinant DNA plasmid vaccine, VRC-SRSDNA015-00-VP, in healthy adult volunteers
Latest Information Update: 03 Nov 2021
At a glance
- Drugs VRC SRSDNA015 00 VP (Primary) ; Coronavirus vaccine
- Indications Severe acute respiratory syndrome
- Focus Adverse reactions; Pharmacodynamics; Therapeutic Use
- 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.
Most Recent Events
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 | - |
Biomarker
NCT Number | Biomarker Name | Biomarker Function |
---|---|---|
NCT00099463 | seryl-tRNA synthetase | Brief Title, Official Title |
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 VPPrimary Drug |
-
|
-
|
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 |
---|---|---|
02 Jul 2017 | Biomarker Update | Biomarkers information updated Updated 03 Nov 2021 |
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
-
Vical Incorporated. SARS Vaccine Achieves Neutralizing Responses in First U.S. Human Trial. Media-Rel 2008;.
Media Release -
National Institute of Allergy and Infectious Diseases. First U.S. SARS Vaccine Trial Opens at NIH. Media-Rel 2004;.
Media Release -
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Vical Incorporated. Vical Announces Fourth-Quarter and Year-End 2004 Financial Results. Media-Rel 2005;.
Media Release -
Vical Incorporated. Vical Reports 2007 Financial Results and Progress in Product Development Programs. Media-Rel 2008;.
Media Release
Adis International Ltd. Part of Springer Science+Business Media
© Springer Nature Switzerland AG