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PostPosted: Mon Sep 22, 2014 12:22 pm 
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Ebola vaccine (ChAd3) clinical trial in Oxford is recruiting.

https://clinicaltrials.gov/ct2/show/NCT ... ola&rank=2

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PostPosted: Mon Sep 22, 2014 12:23 pm 
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Location: Pittsburgh, PA USA
A Study to Assess a New Ebola Vaccine, cAd3-EBO Z
This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Oxford
Sponsor:
University of Oxford
Collaborators:
The Wellcome Trust
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT02240875
First received: September 10, 2014
Last updated: September 17, 2014
Last verified: September 2014
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
The purpose of this study is to assess a new Ebola vaccine, cAd3-EBO Z, at different doses. The study will enable us to assess the safety of the vaccine and the extent of the immune response in healthy volunteers. The investigators will do this by giving volunteers a single vaccination, doing blood tests and collecting information about any symptoms that occur after vaccination. This is the first trial to use this vaccine in humans. The investigators plan to recruit a total of 60 volunteers to be vaccinated.


Condition Intervention Phase
Ebola
Ebola Zaire
Biological: cAd3-EBO Z at 1 x 10^10 vp
Biological: cAd3-EBO Z at 2.5 x 10^10 vp
Biological: cAd3-EBO Z at 5 x 10^10 vp
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase Ia Dose-Escalating, Safety and Immunogenicity Trial of the Monovalent Zaire Ebola Chimpanzee Adenovirus Vector Candidate Vaccine cAd3-EBO Z in Healthy UK Adults

Resource links provided by NLM:

MedlinePlus related topics: Ebola
U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:
Safety and tolerability of the Ebola Zaire vaccine cAd3-EBO Z when administered to healthy volunteers at 3 doses [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.


Secondary Outcome Measures:
Cellular and humoral immunogenicity of the Ebola Zaire vaccine cAd3-EBO Z when administered to healthy volunteers at 3 doses [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The primary immunogenicity outcome measures are ELISA and neutralization antigen-specific assays for antibody responses and intracellular cytokine staining (ICS) assay for T cell responses.


Estimated Enrollment: 60
Study Start Date: September 2014
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Single dose of cAd3-EBO Z at 1 x 10^10 vp intramuscularly
Biological: cAd3-EBO Z at 1 x 10^10 vp
Experimental: Group 2
Single dose of cAd3-EBO Z at 2.5 x 10^10 vp intramuscularly
Biological: cAd3-EBO Z at 2.5 x 10^10 vp
Experimental: Group 3
Single dose of cAd3-EBO Z at 5 x 10^10 vp intramuscularly
Biological: cAd3-EBO Z at 5 x 10^10 vp

Eligibility

Ages Eligible for Study: 18 Years to 50 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:

Healthy adults aged 18 to 50 years
Able and willing (in the Investigator's opinion) to comply with all study requirements
Willing to allow the investigators to discuss the volunteer's medical history with their general practitioner (GP)
For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of screening and vaccination
Agreement to refrain from blood donation during the course of the study
Provide written informed consent
Exclusion Criteria:

Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
Prior receipt of an investigational Ebola or Marburg vaccine, a chimpanzee adenovirus vectored vaccine or any other investigational vaccine likely to impact on interpretation of the trial data
Receipt of any live, attenuated vaccine within 28 days prior to enrolment
Receipt of any subunit or killed vaccine within 14 days prior to enrolment
Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, (e.g. egg products) including urticaria, respiratory difficulty or abdominal pain
Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
Any history of anaphylaxis in reaction to vaccination
Pregnancy, lactation or willingness/intention to become pregnant during the study
History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
History of serious psychiatric condition
Poorly controlled asthma or thyroid disease
Seizure in the past 3 years or treatment for seizure disorder in the past 3 years
Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture
Any other serious chronic illness requiring hospital specialist supervision
Current anti-tuberculosis prophylaxis or therapy
Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
Suspected or known injecting drug abuse in the 5 years preceding enrolment
Seropositive for hepatitis B surface antigen (HBsAg)
Seropositive for hepatitis C virus (antibodies to HCV)
Travel to a Ebola or Marburg endemic region during the study period or within the previous six months
Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis (see Appendix A and Appendix B)
Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02240875

Contacts
Contact: Volunteer Coordinator 01865 857406 vaccinetrials@ndm.ox.ac.uk

Locations
United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Contact: Volunteer Coordinator 01865 857406 vaccinetrials@ndm.ox.ac.uk
Principal Investigator: Adrian V S Hill
Sponsors and Collaborators
University of Oxford
The Wellcome Trust
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Adrian V S Hill University of Oxford
More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02240875 History of Changes
Other Study ID Numbers: EBL01, 2014-003518-10
Study First Received: September 10, 2014
Last Updated: September 17, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:
Ebola
Zaire

ClinicalTrials.gov processed this record on September 18, 2014

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