A phase Ib, open-label, clinical trial to evaluate the safety, tolerability and immunogenicity of the Ebola chimpanzee adenovirus vector vaccines, vrc-eboadc069-00-vp (Cad3-Ebo) and vrc-eboadc076-00-vp (Cad3-Eboz), in healthy adults in Kampala, Uganda

Not Applicable

• Conditions: Ebola; Ebola Hemorrhagic Fever

• Registration Number: PACTR201412000957310
• Lead Sponsor: S National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. 18 to 65 years old.
2. Available for clinical follow-up through Week 48 after enrollment.
3. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
4. Must be willing to be taken home at enrollment visit and allow home visits if participant does not keep appointments
5. Must complete an Assessment of Understanding (AoU) prior to enrollment by answering 9 out of 10 questions at least once in 3 attempts.
6. Able to read (English or Luganda) and willing to complete the informed consent process.
7. Willing to donate blood for sample storage to be used for future research.
8. In good general health without clinically significant medical history.
9. Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) ¿ 40 within the 56 days prior to enrollment.
Laboratory Criteria within 56 days prior to enrollment:
10. Hemoglobin ¿ 11.0 g/dL for women; ¿12.5 g/dL for men.
11. White blood cells (WBC) = 2,500-12,000 cells/mm3.
12. WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.
13. Total lymphocyte count ¿ 800 cells/mm3.
14. Platelets = 125,000 ¿ 400,000/mm3.
15. Alanine aminotransferase (ALT) ¿ 1.25 x upper limit of normal.
16. Serum creatinine ¿ 1 x upper limit of normal.
17. Partial thromboplastin time (PTT) within institutional normal range.
18. Prothrombin time (PT) within institutional normal range.
19. HIV-uninfected as evidenced by a negative FDA-approved HIV diagnostic test.
Female-Specific Criteria:
20. Negative ¿-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment if woman is presumed to be of reproductive potential.
21. 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

1.Investigational Ebola or Marburg vaccine (other than the Ebola DNA vaccine delivered in RV 247) in a prior clinical trial or prior receipt of a cAd3 adenoviral vectored investigational vaccine.
2. Chronic use of immunomodulators and systemic glucocorticoids in daily doses of glucocorticoid equivalence > 20 mg of prednisolone, for periods exceeding 10 days. Non-steroidal anti-inflammatory drugs [NSAIDS] are permitted. Participants that have used less than the stated glucocorticoid dose may still be excluded at the Investigator¿s discretion.
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety

Secondary Outcome Measures

Name	Time	Method
Immunogenicity;Explorative