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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 : Completed
First Posted : July 18, 2018
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oxford

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.


Condition or disease Intervention/treatment Phase
Chikungunya Fever Biological: ChAdOx1 Chik Phase 1

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Chikungunya Virus (CHIKV) Vaccine ChAdOx1 Chik in Healthy Adult Volunteers
Actual Study Start Date : July 31, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya Fever

Arm Intervention/treatment
Experimental: Group 1
Group 1 volunteers (n= 6) will be administered ChAdOx1 Chik, 5 x 10^9 vp through intramuscular route.
Biological: ChAdOx1 Chik
ChAdOx1 Chik, a replication-deficient simian adenoviral vector expressing CHIKV antigens.

Experimental: Group 2
Group 2 volunteers (n= 9) will be administered ChAdOx1 Chik, 2.5 x 10^10 vp through intramuscular route.
Biological: ChAdOx1 Chik
ChAdOx1 Chik, a replication-deficient simian adenoviral vector expressing CHIKV antigens.

Experimental: Group 3
Group 3 volunteers (n= 9) will be administered ChAdOx1 Chik, 5 x 10^10 vp through intramuscular route.
Biological: ChAdOx1 Chik
ChAdOx1 Chik, a replication-deficient simian adenoviral vector expressing CHIKV antigens.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590392


Locations
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United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, United Kingdom
Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: Adrian V Hill, DPhill FRCP Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03590392     History of Changes
Other Study ID Numbers: CHIK001
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Vaccine
Chikungunya Virus
Chikungunya Fever
Additional relevant MeSH terms:
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Chikungunya Fever
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs