Safety, Tolerability, and Immunogenicity of the Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO), VRC-EBOADC069-00-VP, in Healthy Adults

This is an interventional prevention trial for Healthy Adult Immune Responses to Vaccine focused on measuring Filovirus, Healthy, Ebola Hemorrhagic Fever, Immunity, Ebola Virus Read More

• INCLUSION CRITERIA:

A volunteer must meet all of the following criteria:

1. 18 to 50 years old for Groups 1 and 2; 18 to 65 years old for Groups 3, 4, and 5.
2. Available for clinical follow-up through Week 48 after enrollment for groups 1-4 and through at least Week 4 after enrollment for group 5, with no planned travel that would preclude completion of the Study Week 4 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.

8. For Group 3 volunteers only, must have received the VRC-EBODNA023-00-VP (Ebola DNA WT) vaccine in the VRC 206 study.

   Laboratory Criteria within 56 days prior to enrollment:

9. Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.0 g/dL for men.
10. White blood cells (WBC) = 3,300-12,000 cells/mm(3).
11. WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.
12. Total lymphocyte count greater than or equal to 800 cells/mm(3).
13. Platelets = 125,000 400,000/mm(3).
14. Alanine aminotransferase (ALT) less than or equal to 1.25 times upper limit of normal.
15. Serum creatinine less than or equal to 1 times upper limit of normal.
16. Partial thromboplastin time (PTT) within institutional normal range.
17. Prothrombin time (PT) within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.

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

    Female-Specific Criteria:

19. Negative Beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment if woman is presumed to be of reproductive potential.
20. Agrees to use an effective means of birth control from at least 21 days prior to enrollment through 24 weeks after study vaccination if presumed to be of reproductive potential.

EXCLUSION CRITERIA:

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

Volunteer has received any of the following substances:

1. Investigational Ebola or Marburg vaccine in a prior clinical trial (except for Group 3 volunteers) or prior receipt of a cAd3 adenoviral vectored investigational vaccine.
2. Immunosuppressive medications within 2 weeks prior to enrollment.
3. Blood products within 112 days (16 weeks) prior to enrollment.
4. Investigational research agents within 28 days (4 weeks) prior to enrollment.
5. Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.
6. Subunit or killed vaccines within 14 days (2 weeks) prior to enrollment.

7. Current anti-tuberculosis prophylaxis or therapy.

   Female-specific criteria:

8. Woman who is breast-feeding or planning to become pregnant during the first 24 weeks after study vaccine administration.

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

9. Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
10. Clinically significant autoimmune disease or immunodeficiency.
11. Asthma that is not well controlled.
12. Diabetes mellitus (type I or II), with the exception of gestational diabetes.
13. Thyroid disease that is not well controlled.
14. A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
15. Idiopathic urticaria within the last 1 year.
16. Hypertension that is not well controlled.
17. 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.
18. Malignancy that is active or history of a malignancy that is likely to recur during the period of the study.
19. Seizure in the past 3 years or treatment for seizure disorder in the past 3 years.
20. Asplenia or functional asplenia.
21. 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.
22. 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.