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Ebola VaccinesPhase 1NCT00605514

Ebola and Marburg Virus Vaccines

A Phase 1 study testing VRC-EBODNA023-00-VP and VRC-MARDNA025-00-VP in people with Ebola Vaccines and Marburg Virus Disease, 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 determine if experimental vaccines to prevent Ebola virus infection and Marburg virus infection are safe and what side effects, if any, they cause. Ebola virus infection may range from mild to severe, and may cause breathing problems, severe bleeding, kidney problems and shock that can lead to death. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
VRC-EBODNA023-00-VP and VRC-MARDNA025-00-VP
How many people
20 participants
Where
1 siteUnited States
Study dates
25 Jan 2008to 21 Jun 2010
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • The following eligibility criteria apply to initial enrollment into the study:
  • A participant must meet all of the following criteria:
  • 18 to 60 years old
  • Available for clinical follow-up through Week 32
  • Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
  • Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly
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  • Able and willing to complete the informed consent process
  • Willing to donate blood for sample storage to be used for future research
  • In good general health without clinically significant medical history
  • Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) less than 40 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
  • White blood cells (WBC) = 3,300-12,000 cells/mm3
  • Differential either within institutional normal range or accompanied by site physician approval
  • Total lymphocyte count greater than or equal to 800 cells/mm3
  • Platelets = 125,000 - 400,000/mm3
  • Alanine aminotransferase (ALT) less than 1.25 upper limit of normal
  • Serum creatinine less than or equal to 1 x upper limits of normal (less than or equal to1.3 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. [Note: Results of HIV ELISA will be documented, but a negative HIV polymerase chain reaction (PCR) test result will be sufficient for eligibility screening of subjects with positive HIV ELISA that is due to prior participation in an HIV vaccine study]
  • Negative hepatitis B surface antigen (HBsAg)
  • Negative anti-HCV and negative hepatitis C virus (HCV) PCR
  • Partial thromboplastin time (PTT) within institutional normal range
  • Prothrombin time (PT) less than or equal to upper limit of normal
  • FEMALE-SPECIFIC CRITERIA:
  • Negative Beta-HCG 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 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 any other FDA-approved contraceptive method
  • male partner has previously undergone a vasectomy

Who cannot join

  • A SUBJECT WILL BE EXCLUDED IF ONE OR MORE OF THE FOLLOWING CONDITIONS APPLY:
  • Women:
  • Breast-feeding or planning to become pregnant during the first 32 weeks after enrollment
  • SUBJECT HAS RECEIVED ANY OF THE FOLLOWING SUBSTANCES:
  • Investigational Ebola vaccine in a prior clinical trial
  • Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the 12 weeks prior to enrollment. [With the exceptions that use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics; or a short course (duration of 10 days or less, or a single injection) of corticosteroids for a non-chronic condition at least 2 weeks prior to enrollment in this study will not exclude study participation.]
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  • Blood products within 120 days prior to HIV screening
  • Immunoglobulin within 60 days prior to HIV screening
  • Live attenuated vaccines within 30 days prior to initial study vaccine administration
  • Investigational research agents 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-tuberculosis prophylaxis or therapy
  • SUBJECT HAS A HISTORY OF ANY OF THE FOLLOWING CLINICALLY SIGNIFICANT CONDITIONS:
  • Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain
  • Idiopathic urticaria within the past 2 years
  • Autoimmune disease or immunodeficiency
  • Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past 2 years or that requires the use of oral or parenteral 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
  • A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema
  • Hypertension that is not well controlled by medication or blood pressure that is more than 145/95 at enrollment
  • Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions), significant bruising or bleeding difficulties with IM injections or blood draws, or routine use of anticoagulant medications
  • 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 2 years, 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 5 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 subject's ability to give informed consent
  • Eligibility for the Optional 4th Study Injection:
  • Eligibility to receive a 4th injection requires the original consent (Appendix I) to be reviewed again with a study clinician, as well as the consent for the optional 4th injection (Appendix V) to be reviewed and signed. To be eligible the study subject must meet the following criteria:
  • Has completed the 3-injection schedule for the Group in which he/she was enrolled.
  • Has remained in follow-up through Study Week 32 without any serious adverse events.
  • Meets the original study eligibility criteria for hemoglobin, platelets. PT. PTT. Creatinine and ALT within the 28 days prior to the 4th injection.
  • Assessed as continuing to have a healthy vaccine study volunteer status by recent interim history and appropriate physical assessments.
  • If a woman of reproductive potential, is willing to continue with a pregnancy prevention method (from among those meeting the original study eligibility) through 12 weeks after the injection and is confirmed as not pregnant on the day of the 4th injection prior to administration of the injection.
  • Available for clinical follow-up through 12 weeks after the 4th injection.

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 206: A Phase I Study to Evaluate the Safety and Immunogenicity of an Ebola DNA Plasmid Vaccine, VRC-EBODNA023-00-VP, and a Marburg DNA Plasmid Vaccine, VRC-MARDNA025-00-VP, in Healthy Adults

This study will determine if experimental vaccines to prevent Ebola virus infection and Marburg virus infection are safe and what side effects, if any, they cause. Ebola virus infection may range from mild to severe, and may cause breathing problems, severe bleeding, kidney problems and shock that can lead to death. Marburg virus infection causes an illness similar to that caused by the Ebola virus. The vaccines used in this study contain genetic material produced in the laboratory that causes the body to make a small amount of either Ebola or Marburg virus proteins. No Ebola or Marburg virus is in the vaccines.

Normal healthy volunteers between 18 and 60 years of age may be eligible for this study.

Read more

Participants are assigned to receive injections of either the Marburg or the Ebola vaccine. The first group of participants will receive the Marburg vaccine and the second group will receive the Ebola vaccine. The injections are given at 4-week intervals (study weeks 0, 4 and 8). They are given into a muscle with a needleless system called the Biojector(Registered Trademark) 2000.

Participants keep a diary at home (on paper or electronically) for 5 days, in which they record their temperature, symptoms and any reaction at the injection site. They call a study nurse the day after vaccination to report how they feel and return to the clinic for follow-up 2 weeks after each injection (weeks 2, 6 and 10). The visits include a check of vital signs, blood and urine tests, medical history and review of medications taken. Additional visits at weeks 12, 24 and 32 include a check of vital signs, medical history and blood tests.

Read the detailed description

Study Design:

This is an open label Phase I study to evaluate safety, tolerability, and immunogenicity of two recombinant DNA vaccines: one against Marburg virus infections and one against Ebola virus infections. The hypothesis is that each vaccine will be safe for human administration and elicit a humoral and T cell mediated immune response. The primary objectives are to evaluate the safety and tolerability of the investigational vaccines in healthy adults. Secondary and exploratory objectives are related to the immunogenicity of each study vaccine.

Product Description:

VRC-MARDNA025-00-VP (Marburg DNA) is composed of one closed-circular DNA plasmid encoding for the glycoprotein (GP) from the Angola strain of Marburg. VRC-EBODNA023-00-VP (Ebola DNA WT) is composed of two closed-circular DNA plasmids, one encodes for GP from the Zaire strain and one encodes for GP from the Sudan-Gulu strain of Ebola. DNA vaccine vials will be supplied at 4 mg/mL. Each DNA vaccination will be 1 mL of vaccine administered intramuscularly (IM) into the deltoid muscle using the Biojector[R] 2000 Needle-Free Injection Management System (Biojector).

Subjects:

A total of 20 healthy adults, ages 18-60 years, will be enrolled into two groups of 10 subjects each. No more than one subject per group may be in the age range of 51-60 years.

Study Plan:

Subjects will be sequentially enrolled into two groups. Group 1 subjects will receive the Marburg DNA vaccine and Group 2 subjects will receive the Ebola DNA WT vaccine. The first 3 enrollments in each group will occur no faster than one per day. Before completing enrollment into each group, there will be a study pause with review by the Protocol Safety Review Team (PSRT) when there is at least 2 weeks of safety follow-up on the third subject's first injection. Before the initiation of Group 2, the FDA must have assessed administration of the Ebola DNA WT vaccine as safe to proceed. In addition, there will be a study pause with review by the PSRT when there is at least two weeks of safety follow-up on the last subject enrolled into Group 1.

VRC 206 Group 1 will receive Marburg DNA, accrue 10 subjects and deliver injections on Day 0 with a dose 4 mg, Day 28 plus or minus 7 with a dose 4 mg and Day 56 plus or minus 7 with a dose 4 mg.

VRC 206 Group 2 will receive Ebola DNA WT, accrue 10 subjects and deliver injections on Day 0 with a dose of 4 mg, Day 28 plus or minus 7 with a dose 4 mg and Day 56 plus or minus 7 with a dose 4 mg.

The total accrual will be 20 subjects. The injections will be administered at least 21 days between DNA injections.

The original protocol design required 9 clinic visits and 3 telephone follow-up contacts for each subject.

The Version 4.0 protocol amendment allows a 4th injection for those who consent. Consent and administration of the 4th injection could occur anytime in the interval starting with Study Week 32 through Study Week 52. The 4th injection follow-up schedule includes 1 telephone contact and 4 follow-up visits after the injection.

Study Duration: The original study requires 32 weeks of clinical follow up for each participant. Subjects who consent to the amended schedule with a 4th injection will have an additional 12 weeks of follow up.

Being tested
VRC-EBODNA023-00-VP, VRC-MARDNA025-00-VP
Keywords
Hemorrhagic Fever, Healthy, Immunity, T-Cells, Filovirus, Healthy Volunteer, HV
Medical subject headings
Marburg Virus Disease, 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-EBODNA023-00-VPDrug

  • VRC-MARDNA025-00-VPDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety (local and systemic reactogenicity, lab tests, AEs)

Secondary outcomes (1)

  1. Immunogenicity (cellular and humoral immune function assays)

Timeline

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

  1. First posted31 Jan 2008 (estimated)
  2. Study start25 Jan 2008
  3. Primary completion21 Jun 2010
  4. Study completion21 Jun 2010

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
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00605514
Sponsor's protocol ID
080065
Other IDs
08-I-0065
Status last verified
21 Jun 2010
First submitted
29 Jan 2008
Last updated
2 Jul 2017
Results posted
No

Publications

  • Geisbert TW, Jahrling PB. Exotic emerging viral diseases: progress and challenges. Nat Med. 2004 Dec;10(12 Suppl):S110-21. doi: 10.1038/nm1142.

    PubMed 15577929

  • Meslin FX. Global aspects of emerging and potential zoonoses: a WHO perspective. Emerg Infect Dis. 1997 Apr-Jun;3(2):223-8. doi: 10.3201/eid0302.970220.

    PubMed 9204308

  • Okware SI, Omaswa FG, Zaramba S, Opio A, Lutwama JJ, Kamugisha J, Rwaguma EB, Kagwa P, Lamunu M. An outbreak of Ebola in Uganda. Trop Med Int Health. 2002 Dec;7(12):1068-75. doi: 10.1046/j.1365-3156.2002.00944.x.

    PubMed 12460399

  • Sarwar UN, Costner P, Enama ME, Berkowitz N, Hu Z, Hendel CS, Sitar S, Plummer S, Mulangu S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Sullivan NJ, Graham BS, Ledgerwood JE; VRC 206 Study Team. Safety and immunogenicity of DNA vaccines encoding Ebolavirus and Marburgvirus wild-type glycoproteins in a phase I clinical trial. J Infect Dis. 2015 Feb 15;211(4):549-57. doi: 10.1093/infdis/jiu511. Epub 2014 Sep 14.

    PubMed 25225676

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VRC-EBODNA023-00-VP and VRC-MARDNA025-00-VP in people with Ebola Vaccines and Marburg Virus Disease, 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 36 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.

What does the primary outcome measure?

Safety (local and systemic reactogenicity, lab tests, AEs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00605514, which also lists 4 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.

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