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Hemorrhagic Fever, EbolaPhase 1NCT00072605

Experimental Ebola Vaccine Trial

A Phase 1 study testing VRC-EBODNA012-00-VP in people with Hemorrhagic Fever, Ebola and Healthy, 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

This study will test the safety of an experimental vaccine developed to protect against Ebola virus infection and to determine if the vaccine induces an immune response to the virus. The Ebola virus causes a disease called Ebola hemorrhagic fever. Read more about this study

Who is it for?
Ages 18 to 44 yearsHealthy volunteers can take part
Conditions the study is for
Hemorrhagic Fever, Ebola, Healthy
What is being tested?
VRC-EBODNA012-00-VP
How many people
27 participants
Where
1 siteUnited States
Study dates
30 Oct 2003to 22 Aug 2007
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 44 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • A volunteer must meet all of the following inclusion criteria:
  • 18 to 44 years old.
  • Available for follow-up for the duration of the study (12 months).
  • Able to provide proof of identity to the acceptance of the study clinician completing the enrollment process.
  • Completion of 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.
  • In good general health without clinically significant medical history.
  • Physical examination and laboratory results without clinically significant findings within the 28 days prior to enrollment.
  • Laboratory Criteria within 28 days prior to enrollment:
  • Hematocrit equal to 34% for women; 38% for men.
  • Normal fibrinogen levels, D-dimer immunoassay less than 2.0 microg/mL, and RBC morphology without evidence of microangiopathic hemolysis.
  • WBC count: Non-African Americans: equal to 3,300-12,000 cells/mm3, African-Americans: equal to 2,500 - 12,000 cells/mm3 (in the absence of clinical or pathological etiology).
  • Differential either within institutional normal range or accompanied by site physician approval.
  • Total lymphocyte count: Non-African Americans: equal to 800 cells/mm3, African Americans: equal to 650 cells/mm3 (in the absence of clinical or pathological etiology)
  • Platelets within institutional normal limits.
  • Prothrombin time and activated partial thromboplastin time (PT, PTT) within institutional normal range.
  • Alanine aminotransferase (ALT) (also called SGPT) = upper limit of normal range
  • Serum creatinine = upper limit of normal range
  • Negative Food and Drug Administration (FDA)-approved HIV blood test
  • Negative hepatitis B surface antigen (HbsAg)
  • Negative antibody to hepatitis C virus (anti-HCV), or negative HCV PCR if the anti-HCV is positive.
  • Normal urinalysis defined as negative glucose, negative or trace protein, and negative hemoglobin by dipstick.
  • Female-Specific Criteria:
  • Negative pregnancy test (urine or serum) for women presumed to be of reproductive potential.
  • A female participant must meet one 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 throughout the duration of the study,
  • or
  • Participant agrees to consistently practice contraception at least 21 days prior to enrollment and throughout the duration 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:
  • Breast-feeding.
  • Volunteer has received any of the following substances:
  • Immunosuppressive or cytotoxic medications 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.
  • Live attenuated vaccines within 30 days prior to initial study injection.
  • Investigational research agents within 30 days prior to initial study injection.
  • Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days prior to initial study injection.
  • 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.
  • Thyroid disease including history of thyroidectomy and diagnoses 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 or any condition resulting in the absence or removal of 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 by medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
  • Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence or 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: VRC 204 A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiple Strain Ebola DNA Plasmid Vaccine, VRC-EBODNA012-00-VP, in Adult Volunteers

This study will test the safety of an experimental vaccine developed to protect against Ebola virus infection and to determine if the vaccine induces an immune response to the virus. The Ebola virus causes a disease called Ebola hemorrhagic fever. Symptoms begin with fever and muscle aches and progress to breathing problems, severe bleeding, kidney problems, and shock. The infection may be mild, but it can also lead to death. The vaccine used in this study is made from small parts of Ebola genetic material. It cannot cause Ebola hemorrhagic fever to develop in those who receive it.

Healthy volunteers 18 to 44 years of age may be eligible for this study. Candidates will be screened with a medical history, physical examination, and laboratory tests, and complete an "assessment of understanding" questionnaire to show that they understand the study.

Read more

Depending on their order of entry into the study, participants are assigned to receive one of three vaccine doses or placebo. The first group receives the lowest dose (2 milligram) of vaccine or placebo. If this dose is safe, then the second group receives 4 mg, and if this dose is safe, the third group receives 8 mg. Injections are given in a muscle in the upper arm. Participants receive three injections, each 4 weeks apart (on study days 0, 28, and 56).

Participants record their temperature and symptoms in a diary card for 7 days following each injection. They return to the clinic 2 to 3 days after each injection and then 2 weeks after each injection until study week 10. Additional follow-up visits are then scheduled at weeks 12, 24, 38, and 52. At each visit, participants provide a blood and urine sample for testing and have their vital signs, and lymph nodes checked, their weight measured, and their symptoms reviewed. Additional laboratory tests may be requested between visits.

Read the detailed description

This is a Phase I, randomized, placebo-controlled, dose-escalation study of an Ebola DNA plasmid vaccine. The hypothesis is that the vaccine will be safe for human administration and elicit immune responses to Ebola. Primary objectives are to evaluate the safety and tolerability of the investigational vaccine and the secondary objective is to evaluate immune responses. Randomization assignment will be blinded to subjects, clinical investigators and laboratory investigators.

Being tested
VRC-EBODNA012-00-VP
Keywords
Healthy, T Cells, Immunity, Hemorrhagic Fever, Healthy Volunteer, HV
Medical subject headings
Hemorrhagic Fever, Ebola, Hemorrhagic Fevers, Viral

What participants receive

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

  • VRC-EBODNA012-00-VPDrug

Timeline

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

  1. First posted5 Nov 2003 (estimated)
  2. Study start30 Oct 2003
  3. Study completion22 Aug 2007

Resources

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
27 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00072605
Sponsor's protocol ID
040028
Other IDs
04-I-0028
Status last verified
22 Aug 2007
First submitted
4 Nov 2003
Last updated
17 Dec 2019
Results posted
No

Publications

  • Birmingham K, Cooney S. Ebola: small, but real progress. Nat Med. 2002 Apr;8(4):313. doi: 10.1038/nm0402-313. No abstract available.

    PubMed 11927920

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VRC-EBODNA012-00-VP in people with Hemorrhagic Fever, Ebola and Healthy, 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 25 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 17 Dec 2019. 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 NCT00072605, which also lists 1 linked publication.

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 17 Dec 2019.

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