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Ebola Hemorrhagic FeverPhase 1NCT00374309

Experimental Vaccine for Prevention of Ebola Virus Infection

A Phase 1 study testing VRC-EBOADV018-00-VP in people with Ebola Hemorrhagic Fever and Ebola 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 an experimental vaccine to prevent Ebola virus infection is safe and what side effects, if any, it causes. 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 50 yearsHealthy volunteers can take part
What is being tested?
VRC-EBOADV018-00-VP
How many people
48 participants
Where
1 siteUnited States
Study dates
5 Sep 2006to 5 May 2009
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 subject must meet all of the following criteria:
  • 18 to 50 years old.
  • Available for clinical follow-up through Week 48.
  • 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.
  • Able and willing to complete the informed consent process.
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  • 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) equal to 3,300-12,000 cells/mm(3)
  • Differential either within institutional normal range or accompanied by site physician approval
  • Total lymphocyte count greater than or equal to 800 cells/mm(3)
  • Platelets equal to 125,000 - 400,000/mm(3)
  • Alanine aminotransferase (ALT) less than or equal to 1.25 upper limit of normal
  • Serum creatinine less than or equal to 1 x upper limits 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, at low risk of HIV exposure as assessed by behavioral risk interview, and amenable to HIV risk reduction counseling. [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.
  • a PTT within institutional normal range and PT less than or equal to upper limit of institutional normal range.
  • 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 24 of the study, OR
  • Participant agrees to consistently practice contraception at least 21 days prior to enrollment and through Week 24 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 24 weeks after enrollment.
  • Subject has received any of the following substances:
  • Ebola vaccines or any recombinant adenoviral vector vaccine in a prior clinical trial.
  • Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past six months. [Note: that use of corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics are not excluded.]
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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 two 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 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 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.
  • 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.
  • A family history of pulmonary embolism associated with deep vein thrombosis without a known cause (such as hormonal contraceptive use or neoplasm) in a biologically related parent, sibling, child under the age of 60 years, or a family history of systemic lupus erythematosus in a biologically related parent, sibling, or child of any age.

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 Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Ebola Adenoviral Vector Vaccine, VRC-EBOADV018-00-VP, in Healthy Adults

This study will determine if an experimental vaccine to prevent Ebola virus infection is safe and what side effects, if any, it causes. 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. The vaccine used in this study contains man-made genetic material similar to one part of the Ebola virus, which is designed to stimulate an immune response to the virus. The vaccine itself cannot cause Ebola virus infection because it does not contain any Ebola virus.

Participants are assigned to one of three groups as they enter into the study. Of the first 16 people in the study, 12 receive the lowest study dose of vaccine and 4 receive placebo (an inactive substance). If this dose is safe, then of the next 16 people who enter the study, 12 receive a higher dose of the vaccine, and the remaining 4 receive placebo. If this dose is safe, the final 12 people in the last group of 16 receive the highest study dose, and 4 receive placebo. The vaccine is given as a single injection in the arm on the day of enrollment.

Read more

Participants keep a diary for 5 days, recording 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 they return to the clinic approximately six times for follow-up evaluations. These visits may include a check of vital signs, physical examination, blood and urine tests, or other medical tests if needed.

...

Read the detailed description

Study Design:

This is a Phase I, randomized, placebo-controlled, double-blinded study to examine safety, tolerability and immune response of a recombinant Ebola adenovirus serotype 5 vector (Ebola-rAd5) vaccine in healthy adults. The hypothesis is that this vaccine will be safe and elicit immune responses to Ebola. The primary objective is to evaluate the safety and tolerability of the investigational vaccine VRC-EBOADV018-00-VP in healthy subjects. The secondary objectives include immunogenicity evaluations and adenovirus serotype 5 antibody titers (Ad5 Ab) at Weeks 0, 4, and 24. Exploratory evaluations include immunogenicity evaluations at Weeks 2, 12, and 48.

Product Description:

VRC-EBOADV018-00-VP is a recombinant product composed of two replication-deficient recombinant adenovirus serotype 5 (rAd5) vectors encoding for glycoprotein (GP), one from the Zaire strain and one from the Sudan-Gulu strain of Ebola. The final formulation buffer will be used as the diluent and as the placebo control (Crucell placebo). Injections will be administered intramuscularly (IM) by needle and syringe.

Subjects:

Healthy adult subjects ages 18 to 50 years old.

Study Plan:

Forty-eight subjects will receive a 1 mL intramuscular (IM) deltoid injection, via needle and syringe, of the study agent or placebo in a deltoid muscle as shown in the schema. Dose escalation will occur about three weeks after the last injection in the preceding dose group following an interim safety data review by a Data and Safety Monitoring Board (DSMB), provided that there are no significant toxicities. No more than one subject per day will be enrolled for the first 6 enrollments into each dosage group and the sixth subject enrolled must have 5 days (Group 1) or 14 days (Group 2 and Group 3) of follow-up before proceeding with further enrollments into that group.

Study Duration:

Subjects will be evaluated at 7 or more clinical visits during the 48 weeks after the study injection.

Study Endpoints:

The primary endpoint is safety and tolerability of the vaccine administered at doses of 2 x 10(9), 2 x 10(10) and 2 x 10(11) virus particles (VP) by IM injection. Secondary endpoints are immunogenicity as indicated by Ebola-specific antibody and cellular immune responses at Weeks 0, 4 and 24 and Ad5 antibody titer at Weeks 0, 4, and 24. Exploratory analyses of immunogenicity will also be conducted on stored samples collected at other timepoints including Weeks 2, 12 and 48.

Being tested
VRC-EBOADV018-00-VP
Keywords
Hemorrhagic Fever, Healthy, Immunity, T -Cells, Filovirus, 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-EBOADV018-00-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, AE's).

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 posted11 Sep 2006 (estimated)
  2. Study start5 Sep 2006
  3. Study completion5 May 2009

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
48 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00374309
Sponsor's protocol ID
060237
Other IDs
06-I-0237
Status last verified
5 May 2009
First submitted
8 Sep 2006
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VRC-EBOADV018-00-VP in people with Ebola Hemorrhagic Fever and Ebola 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 33 inclusion and 28 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, AE's).. 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 NCT00374309, which also lists 3 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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