VRC 208: Dose, Safety and Immunogenicity of a Recombinant Modified Vaccinia Virus Ankara Ebola Vaccine, VRC-EBOMVA079-00-VP (MVA-EbolaZ), Administered Alone or as a Boost to cAd3-Ebola Vaccines in Healthy Adults



Status:Completed
Healthy:No
Age Range:18 - 66
Updated:4/17/2018
Start Date:March 26, 2015
End Date:April 6, 2017

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VRC 208: Phase 1/1b Open-Label Clinical Trial to Evaluate Dose, Safety and Immunogenicity of Recombinant Modified Vaccinia Virus Ankara Ebola Vaccine,VRC-EBOMVA079-00-VP, Administered Alone or as Boost to cAd3-Ebola Vaccines in Healthy Adults

Background:

- Ebola virus is a rare disease that starts with fever and muscle aches, but can lead to
death. The 2014 Ebola outbreak in West Africa is the largest to date. There are no approved
treatments for Ebola. Researchers want to see if two new vaccines VRC-EBOMVA079-00-VP
(MVA-EbolaZ) and VRC-EBOADC069-00VP ( cAd3-EBO ) are safe and able to induce an immune
response against Ebola.

Objectives:

- To see if the two new vaccines are safe and if they cause any side effects. Also, to study
immune responses to the vaccines.

Eligibility:

- Healthy adults ages 18-66

Design:

- Participants will get one or two study vaccine injections depending on the study group
they are assigned to. Each injection will repeat the same schedule:

- A needle and syringe will inject the vaccine into an upper arm muscle.

- 1-2 days later, participants must call the clinic to report how they feel.

- For 7 days they will check their temperature with a thermometer given to them. They will
look at the injection site, and measure any redness or swelling with a ruler. They will
write down any symptoms they have.

- In the first 2 months, participants will have at least 6 clinic visits and 1 phone
contact. At each visit, participants will be checked for health changes or problems.
They will tell how they feel and if they have taken any medications. Blood and urine
samples may be collected.

- Participants might need to have extra clinic visits and laboratory tests if they have
health changes that need to be checked.

This Phase 1/1b study will examine dose, safety, tolerability and immunogenicity of an
investigational MVA-vectored Ebola vaccine in healthy adults. The vaccine encodes wild type
(WT) glycoprotein (GP) from Zaire strain of Ebola and will be administered intramuscularly
(IM) with needle and syringe. The safety and tolerability of the MVA-EbolaZ will be evaluated
at escalating doses of 1x10(7) and 1x10(8) plaque forming units (PFU). Part 1 includes
enrollment of vaccine-naive subjects to conduct a dose escalation of the MVA-EbolaZ vaccine
and to evaluate the vaccine as a boost for the cAd3-EBO vaccine. In Part 2 of the study, up
to 140 subjects who received the cAd3-EBO or cAd3-EBOZ vaccine in VRC 207 study will be
boosted with MVA-EbolaZ. The hypotheses are that the study vaccines will be safe and elicit
immune responses to Ebola GP, and that the prime-boost regimens will be safe and result in a
more polyfunctional response to Ebola GP that is of greater magnitude and duration than
response to either of the vaccines alone.

- INCLUSION CRITERIA:

Inclusion Criteria for Groups 1, 2, and 3.

A volunteer must meet all of the following criteria to be eligible:

1. 18 to 50 years old.

2. Available for clinical follow-up through the last study visit.

3. Able to provide proof of identity to the satisfaction of the study clinician
completing the enrollment process.

4. Able and willing to complete the informed consent process.

5. Willing to donate blood for sample storage to be used for future research.

6. In good general health without clinically significant medical history.

7. Physical examination and laboratory results without clinically significant findings
and a body mass index (BMI) less than or equal to 40 within the 56 days prior to
enrollment.

Laboratory Criteria within 56 days prior to enrollment:

8. Hemoglobin within institutional normal range or accompanied by the Principal
Investigator (PI) or designee approval.

9. White blood cells (WBC) = 3,300-12,000 cells/mm(3).

10. WBC differential either within institutional normal range or accompanied by the PI or
designee approval.

11. Total lymphocyte count greater than or equal to 800 cells/mm(3).

12. Platelets = 125,000-400,000/mm(3).

13. Alanine aminotransferase (ALT) less than or equal to 1.25 times upper limit of normal.

14. Serum creatinine less than or equal to 1.1 times upper limit of normal.

15. Partial thromboplastin time (PTT) less than or equal to 1.1 times upper limit of
normal or accompanied by the Principal Investigator (PI) or designee approval.

16. Prothrombin time (PT) less than or equal to1.1 times upper limit of normal or
accompanied by the Principal Investigator (PI) or designee approval.

17. HIV-uninfected as evidenced by a negative FDA-approved HIV diagnostic blood test.

-Female-Specific Criteria:

18. Negative beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on
day of enrollment if woman is presumed to be of reproductive potential.

19. Agrees to use an effective means of birth control from at least 21 days prior to
enrollment through 24 weeks after last study vaccination if presumed to be of
reproductive potential.

EXCLUSION CRITERIA:

Exclusion Criteria for Groups 1, 2, and 3

A volunteer will be excluded if one or more of the following conditions apply:

Volunteer has received any of the following substances:

1. Investigational Marburg vaccine in a prior clinical trial.

2. Investigational Ebola vaccine in a prior clinical trial.

3. Investigational cAd3 or MVA vaccines in a prior clinical trial.

4. Evidence of increased cardiovascular disease risk defined as >10% five year risk by
the non-laboratory method.

5. Electrocardiogram (ECG) with clinically significant abnormalities (examples may
include: pathologic Q waves, significant ST-T wave changes, left ventricular
hypertrophy, any non-sinus rhythm excluding isolated premature atrial contractions,
right or left bundle branch block, advanced A-V heart block). ECG abnormalities
determined by a cardiologist to be clinically insignificant as related to study
participation do not preclude study enrollment.

6. Type 1 hypersensitivity reaction to aminoglycoside antibiotics.

7. More than 10 days of systemic immunosuppressive medications except for short-term
treatments of minor ailments in otherwise healthy volunteers, or cytotoxic medications
within the 4 weeks prior to enrollment, or any within the 14 days prior to enrollment.

8. Blood products within 112 days (16 weeks) prior to enrollment.

9. Investigational research agents within 28 days (4 weeks) prior to enrollment.

10. Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.

11. Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal within 2
weeks of initial study vaccine administration unless approved by the study Principal
Investigator (PI) or designee

12. Current anti-tuberculosis prophylaxis or therapy.

-Female-specific criteria:

13. Woman who is breast-feeding or planning to become pregnant during the 24 weeks of
study participation.

-Volunteer has a history of any of the following clinically significant conditions:

14. Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives),
respiratory difficulty, angioedema, or abdominal pain.

15. Clinically significant autoimmune disease or immunodeficiency.

16. Asthma that is not well controlled.

17. Diabetes mellitus (type I or II), with the exception of gestational diabetes.

18. Thyroid disease that is not well controlled.

19. A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic
forms of angioedema.

20. Idiopathic urticaria within the last 1 year.

21. Hypertension that is not well controlled.

22. 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.

23. Malignancy that is active or history of a malignancy that is likely to recur during
the period of the study.

24. Seizure in the past 3 years or treatment for seizure disorder in the past 3 years.

25. Asplenia or functional asplenia.

26. Psychiatric condition that precludes compliance with the protocol; past or present
psychoses; or within five years prior to enrollment, history of a suicide plan or
attempt.

27. 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.
We found this trial at
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621 West Lombard Street
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(410) 706-7101
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