HealthyPhase 1NCT00106769

Vaccine to Prevent West Nile Virus Disease

A Phase 1 study testing VRC-WNVDNA017-00-VP in people with Healthy and West Nile Fever, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, West Nile Fever, Healthy Volunteer
What is being tested?: VRC-WNVDNA017-00-VP
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 22 Mar 2005to 15 Jan 2008
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

A participant must meet all of the following criteria:
18 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.

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Willing to receive HIV test results and willing 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).
Platelets = 125,000 - 400,000/mm(3).
ALT (SGPT) less than or equal to 1.25 x upper limit of normal.
Serum creatinine less than or equal to 1 x upper limit of normal (less than or equal to 1.3 mg/dL for females; less than or equal to 1.4 mg/dL for males).
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 and negative HCV PCR.
Laboratory Criteria within 12 weeks (84 days) prior to enrollment:
Negative flavivirus serology within 84 days prior to enrollment and no history of prior vaccination against yellow fever or Japanese encephalitis virus.
Female-Specific Criteria:
Negative Beta-HCG pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.
A female participant must meet any of the following criteria:
No reproductive potential because of menopause (one year without menses) or because of a hysterectomy, bilateral oophorectomy, or tubal ligation
or
Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and through Week 32 of the study,
or
Participant agrees to consistently practice contraception at least 21 days prior to enrollment and through Week 32 of the study by one of the following methods:
condoms, male or female, with or without a spermicide;
diaphragm or cervical cap with spermicide;
intrauterine device;
contraceptive pills or patch, Norplant, Depo-Provera or other FDA-approved contraceptive method;
male partner has previously undergone a vasectomy for which there is documentation.

Who cannot join

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;

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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.
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 145/95 at enrollment.
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 the 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 of the spleen.
Allergic reaction to aminoglycoside antibiotics.
Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five years prior to enrollment, a history of suicide plan or attempt.
Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Phase I Study of the Safety and Immunogenicity of a West Nile Virus Recombinant DNA Plasmid Vaccine, VRC-WNVDNA017-00 VP, in Healthy Adult Volunteers

This study will test the safety of an experimental vaccine intended to prevent West Nile virus (WNV) infection and determine if it causes side effects. WNV symptoms may vary from fever and headache, to a polio-like syndrome with paralysis. Infection rarely results in death. The vaccine used in this study contains DNA that instructs the body to produce a small amount of a protein found in WNV. If the body creates resistance or immunity to these proteins, then the vaccine may protect against WNV. Study participants cannot get WNV from the vaccine.

Healthy volunteers between 18 years and 50 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests, including a pregnancy test for women who can become pregnant. Patients undergo the following tests and procedures:

Vaccine injections: Vaccines are given as injections in the upper arm, using a needleless system called the Biojector 2000. The first injection is on study day 0, the second on day 28 (+/-) 7 days, and the third on day 56 (+/-) 7 days. There must be at least 21 days between injections. The pregnancy test for women of childbearing potential is repeated the day of each vaccine injection.
Diary card: Participants are given a 5-day diary card after each injection to record their temperature and any symptoms and side effects they may experience for up to 5 days after the injection. The diary cards are returned to the clinic at visits scheduled 2 weeks after each injection. Side effects and symptoms also must be reported immediately to a study nurse or doctor, and a clinic visit may be required for an examination.
Clinic visits: At day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32, participants have a medical history, physical examination (if needed) and blood tests. Vital signs and weight are also recorded. Lymph nodes are examined at day 0 and weeks 2, 4, 6, 8, 10 and 12, and urine samples are collected at day 0 and weeks 2, 4, 6, 8 and 10.

Some of the blood drawn during this study is used for genetic tests to see if different types of immune response to a vaccine are related to genetic differences in people.

Read the detailed description

Study Design: This is a Phase I open label study to evaluate safety, tolerability, and immune response of a recombinant DNA vaccine, VRC-WNVDNA017-00-VP. The hypothesis is that this regimen will be safe for human administration and elicit immune responses to the West Nile virus. 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-WNVDNA017-00-VP is composed of a single closed circular DNA plasmid that encodes the WNV viral proteins precursor transmembrane (PrM) and envelope (E). 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: Fifteen 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 ELISPOT and an intracellular cytokine staining (ICS) assay for WNV-specific T cell responses and a WNV ELISA assay. The principal timepoints for ICS and ELISPOT are Week 0 (baseline), Week 8 and Week 12. ICS and ELISPOT at other study timepoints, as well as other immunogenicity assays through Week 32, will be completed as exploratory evaluations. Stored sera will be tested for WNV neutralizing antibody once an assay is developed.

Conditions: Healthy, West Nile Fever, Healthy Volunteer, HV
Being tested: VRC-WNVDNA017-00-VP
Keywords: Flavivirus, Mosquito, Immunity, Preventive, Virus, West Nile Fever, Healthy Volunteer, HV
Medical subject headings: West Nile Fever, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VRC-WNVDNA017-00-VPDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 200515 Jan 2008

First posted30 Mar 2005 (estimated)
Study start22 Mar 2005
Study completion15 Jan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Enrolment: 15 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00106769
Sponsor's protocol ID: 050126
Other IDs: 05-I-0126
Status last verified: 15 Jan 2008
First submitted: 29 Mar 2005
Last updated: 2 Jul 2017
Results posted: No

Publications

Centers for Disease Control and Prevention (CDC). West Nile virus activity--United States, September 29-October 5, 2004. MMWR Morb Mortal Wkly Rep. 2004 Oct 8;53(39):922-3.
PubMed 15470326
Martin JE, Pierson TC, Hubka S, Rucker S, Gordon IJ, Enama ME, Andrews CA, Xu Q, Davis BS, Nason M, Fay M, Koup RA, Roederer M, Bailer RT, Gomez PL, Mascola JR, Chang GJ, Nabel GJ, Graham BS. A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults during a phase 1 clinical trial. J Infect Dis. 2007 Dec 15;196(12):1732-40. doi: 10.1086/523650.
PubMed 18190252

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study of the Safety and Immunogenicity of a West Nile Virus Recombinant DNA Plasmid Vaccine, VRC-WNVDNA017-00 VP, in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT00106769
Acronym / sponsor ID: 050126
Conditions: Healthy, West Nile Fever, Healthy Volunteer, HV
Keywords: Flavivirus, Mosquito, Immunity, Preventive, Virus, West Nile Fever, Healthy Volunteer, HV
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: 22 Mar 2005
Study completion: 15 Jan 2008
First posted: 30 Mar 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Vaccine injections: Vaccines are given as injections in the upper arm, using a needleless system called the Biojector 2000. The first injection is on study day 0, the second on day 28 (+/-) 7 days, and the third on day 56 (+/-) 7 days. There must be at least 21 days between injections. The pregnancy test for women of childbearing potential is repeated the day of each vaccine injection.
Diary card: Participants are given a 5-day diary card after each injection to record their temperature and any symptoms and side effects they may experience for up to 5 days after the injection. The diary cards are returned to the clinic at visits scheduled 2 weeks after each injection. Side effects and symptoms also must be reported immediately to a study nurse or doctor, and a clinic visit may be required for an examination.
Clinic visits: At day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32, participants have a medical history, physical examination (if needed) and blood tests. Vital signs and weight are also recorded. Lymph nodes are examined at day 0 and weeks 2, 4, 6, 8, 10 and 12, and urine samples are collected at day 0 and weeks 2, 4, 6, 8 and 10.

Some of the blood drawn during this study is used for genetic tests to see if different types of immune response to a vaccine are related to genetic differences in people.

Detailed description

Subjects: Healthy adult volunteers (18 to 50 years old) will be enrolled.

Study Plan: Fifteen 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 design

Primary purpose: Treatment

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (37 listed)

18 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.

Key exclusion criteria (26 listed)

Woman who is breast-feeding or planning to become pregnant during the 32 weeks of study participation.
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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VRC-WNVDNA017-00-VP	Drug	–

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
Background: PubMed 15470326Centers for Disease Control and Prevention (CDC). West Nile virus activity--United States, September 29-October 5, 2004. MMWR Morb Mortal Wkly Rep. 2004 Oct 8;53(39):922-3.
Derived from this study: PubMed 18190252Martin JE, Pierson TC, Hubka S, Rucker S, Gordon IJ, Enama ME, Andrews CA, Xu Q, Davis BS, Nason M, Fay M, Koup RA, Roederer M, Bailer RT, Gomez PL, Mascola JR, Chang GJ, Nabel GJ, Graham BS. A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults during a phase 1 clinical trial. J Infect Dis. 2007 Dec 15;196(12):1732-40. doi: 10.1086/523650.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VRC-WNVDNA017-00-VP in people with Healthy and West Nile Fever, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 37 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00106769, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.