Status:
COMPLETED
Safety, Tolerability, and Immunogenicity of the Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO), VRC-EBOADC069-00-VP, in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Healthy Adult Immune Responses to Vaccine
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Background: \- Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the l...
Detailed Description
Study Design: This is a Phase 1/1b, open-label study to examine safety, tolerability and immunogenicity of investigational Ebola vaccines in healthy adults. Part 1 is a Phase 1 dose escalation of the ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A volunteer must meet all of the following criteria:
- 18 to 50 years old for Groups 1 and 2; 18 to 65 years old for Groups 3, 4, and 5.
- 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.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Able and willing to complete the informed consent process.
- 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 or equal to 40 within the 56 days prior to enrollment.
- 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:
- Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.0 g/dL for men.
- White blood cells (WBC) = 3,300-12,000 cells/mm(3).
- WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.
- Total lymphocyte count greater than or equal to 800 cells/mm(3).
- Platelets = 125,000 400,000/mm(3).
- Alanine aminotransferase (ALT) less than or equal to 1.25 times upper limit of normal.
- Serum creatinine less than or equal to 1 times upper limit of normal.
- Partial thromboplastin time (PTT) within institutional normal range.
- Prothrombin time (PT) within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.
- HIV-uninfected as evidenced by a negative FDA-approved HIV diagnostic blood test.
- Female-Specific Criteria:
- Negative Beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment if woman is presumed to be of reproductive potential.
- 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:
- 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.
- Immunosuppressive medications within 2 weeks prior to enrollment.
- Blood products within 112 days (16 weeks) prior to enrollment.
- Investigational research agents within 28 days (4 weeks) prior to enrollment.
- Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.
- Subunit or killed vaccines within 14 days (2 weeks) prior to enrollment.
- Current anti-tuberculosis prophylaxis or therapy.
- Female-specific criteria:
- 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:
- Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
- Clinically significant autoimmune disease or immunodeficiency.
- Asthma that is not well controlled.
- Diabetes mellitus (type I or II), with the exception of gestational diabetes.
- Thyroid disease that is not well controlled.
- A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
- Idiopathic urticaria within the last 1 year.
- Hypertension that is not well controlled.
- 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.
- Malignancy that is active or history of a malignancy that is likely to recur during the period of the study.
- Seizure in the past 3 years or treatment for seizure disorder in the past 3 years.
- Asplenia or functional asplenia.
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
August 27 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2017
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT02231866
Start Date
August 27 2014
End Date
April 5 2017
Last Update
July 5 2018
Active Locations (3)
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1
Hope Clinic - Emory Vaccine Ctr
Decatur, Georgia, United States, 30030
2
University of Maryland Center for Vaccine Development
Baltimore, Maryland, United States, 21201-1595
3
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892