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Safety and Immunogenicity of a Candidate CHIKV Vaccine (CHIK001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03590392
Recruitment Status : Active, not recruiting
First Posted : July 18, 2018
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE June 5, 2018
First Posted Date  ICMJE July 18, 2018
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE July 31, 2018
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2018)
Occurrence of solicited and unsolicited local and systemic adverse events [ Time Frame: Solicited and Unsolicited AEs will be collected for 28 days. SAEs will be collected from enrolment until the end of the follow-up period (i.e 6 months) ]
Occurrence of solicited and unsolicited local and systemic adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03590392 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
Measures of immunogenicity to the ChAdOx1 Chik in healthy adults volunteers [ Time Frame: Up to 26 weeks ]
Measures of immunogenicity to the ChAdOx1 Chik in healthy adults volunteers. Immunogenicity will be assessed by ELISA and ELISpot assays on the following days: 0 (vaccination visit), 14, 28, 56, and 182.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2018)
Measures of immunogenicity to the ChAdOx1 Chik in healthy adults volunteers [ Time Frame: Immunogenicity will be assessed by ELISA and ELISpot assays on the following days: 0 (vaccination visit), 14, 28, 56, and 182. ]
Measures of immunogenicity to the ChAdOx1 Chik in healthy adults volunteers
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of a Candidate CHIKV Vaccine (CHIK001)
Official Title  ICMJE A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Chikungunya Virus (CHIKV) Vaccine ChAdOx1 Chik in Healthy Adult Volunteers
Brief Summary

A phase I dose escalation study to assess the safety and immunogenicity of the candidate vaccine ChAdOx1 Chik in healthy volunteers.

Volunteers will be recruited and vaccinated in Oxford, England.

All vaccinations will be administered intramuscularly. Three different doses will be tested (5x10^9 vp, 2.5x10^10 vp and 5x10^10vp).

The total duration of the study will be 26 weeks from the day of enrolment for all volunteers.

Detailed Description

This is a phase I, open label, dose escalation trial to assess the safety and immunogenicity of the ChAdOx1 Chik vaccine in healthy volunteers

There will be 3 study groups with a total of 24 volunteers. ChAdOx1 Chik will be administered intramuscularly as a single vaccination at 3 different doses: 5x10^9 vp (group 1), 2.5x10^10 (group 2) and 5x10^10 vp (group 3)

Vaccination of groups will be sequential from Group 1 to Group 3 with interim safety reviews prior to dose escalation

Volunteers will be recruited and undergo screening, vaccination and follow-up visits at the trial site. Blood samples for safety and immunology purposes will be performed on the visit time points indicated in the schedule of attendances.

Safety will be assessed by the frequency, incidence and nature of adverse events and serious adverse events arising during the study.

Immune responses will be assessed pre and post vaccination procedure at different time points throughout the trial

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chikungunya Fever
Intervention  ICMJE Biological: ChAdOx1 Chik
ChAdOx1 Chik, a replication-deficient simian adenoviral vector expressing CHIKV antigens.
Study Arms  ICMJE
  • Experimental: Group 1
    Group 1 volunteers (n= 6) will be administered ChAdOx1 Chik, 5 x 10^9 vp through intramuscular route.
    Intervention: Biological: ChAdOx1 Chik
  • Experimental: Group 2
    Group 2 volunteers (n= 9) will be administered ChAdOx1 Chik, 2.5 x 10^10 vp through intramuscular route.
    Intervention: Biological: ChAdOx1 Chik
  • Experimental: Group 3
    Group 3 volunteers (n= 9) will be administered ChAdOx1 Chik, 5 x 10^10 vp through intramuscular route.
    Intervention: Biological: ChAdOx1 Chik
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy adults aged 18 to 50 years
  2. Able and willing (in the Investigator's opinion) to comply with all study requirements
  3. Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
  4. For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
  5. Agreement to refrain from blood donation during the course of the study
  6. Provide written informed consent

Exclusion Criteria:

  1. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
  2. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccine).
  3. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
  4. 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)
  5. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
  6. Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
  7. Any history of anaphylaxis in relation to vaccination
  8. Pregnancy, lactation or willingness/intention to become pregnant during the study
  9. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  10. History of serious psychiatric condition likely to affect participation in the study
  11. Bleeding disorder (eg. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
  12. Any other serious chronic illness requiring hospital specialist supervision
  13. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
  14. Suspected or known injecting drug abuse in the 5 years preceding enrolment
  15. Seropositive for hepatitis B surface antigen (HBsAg)
  16. Seropositive for hepatitis C virus (antibodies to HCV)
  17. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
  18. 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
  19. Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate
  20. Prior exposure to CHIKV (serology will be requested at the discretion of the investigator)
  21. Travel to a CHIKV endemic region throughout the duration of the participants enrolment in the Study and within the preceding 30 days.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03590392
Other Study ID Numbers  ICMJE CHIK001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adrian V Hill, DPhill FRCP Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom
PRS Account University of Oxford
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP