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

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201412000957310
• Date of registration: 03/12/2014
• Prospective Registration: Yes
• Primary sponsor: US National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 05/01/2015
• Target sample size: 90
• Recruitment status: Pending
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=957
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a radomisation table created by a computer software program. A total of 90 subjects will be enrolled to receive one of two vaccines with 30 subjects receiving the cAd3-EBOZ and 60 subjects receiving cAd3-EBO. Enrollment to the latter is further stratified on Ebola vaccination history with Ebola vaccine naive subjects randomized 1:1:1:1 to Groups 1a, 1b, 1c and 1d and subjects with a prior Ebola vaccination randomized 1:1 between Groups 2a and 2b.,NA. This is an open label Clinical Trial
• Phase: Not Applicable

Countries of recruitment

Uganda

Contacts

• Name: Jauhara Nanyondo
• Affiliation: Community Outreach Coordinator

• Name: Allan Tindikahwa
• Affiliation: Pharmacist of Record

Key inclusion & exclusion criteria

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

Age minimum: 18 Year(s)
Age maximum: 65 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Ebola
Ebola Hemorrhagic Fever

Ebola

Ebola Hemorrhagic Fever

Intervention(s)

cAd3-EBO for GROUP II

cAd3-EBOZ

cAd3-EBO

Primary Outcome(s)

Safety

Secondary Outcome(s)

Explorative

Immunogenicity

Secondary ID(s)

Pending

MUSPH#247

WRAIR#2170

Source(s) of Monetary Support

US National Institute of Allergy and Infectious Diseases (NIAID)

Ethics review

Status: Approved
Approval date: 27/11/2014
Contact:

Makerere University School of Public Health REC