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Safety and Immunogenicity of a Candidate CHIKV Vaccine (CHIK001)

Primary Purpose

Chikungunya Fever

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

ChAdOx1 Chik

About this trial

This is an interventional treatment trial for Chikungunya Fever focused on measuring Vaccine, Chikungunya Virus, Chikungunya Fever

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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
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
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 vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccine).
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
Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
Any history of anaphylaxis in relation 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 likely to affect participation in the study
Bleeding disorder (eg. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
Any other serious chronic illness requiring hospital specialist supervision
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)
Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
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
Prior exposure to CHIKV (serology will be requested at the discretion of the investigator)
Travel to a CHIKV endemic region throughout the duration of the participants enrolment in the Study and within the preceding 30 days.

Sites / Locations

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Group 1 volunteers (n= 6) will be administered ChAdOx1 Chik, 5 x 10^9 vp through intramuscular route.

Group 2 volunteers (n= 9) will be administered ChAdOx1 Chik, 2.5 x 10^10 vp through intramuscular route.

Group 3 volunteers (n= 9) will be administered ChAdOx1 Chik, 5 x 10^10 vp through intramuscular route.

Outcomes

Primary Outcome Measures

Occurrence of solicited and unsolicited local and systemic adverse events

Secondary Outcome Measures

Measures of immunogenicity to the ChAdOx1 Chik in healthy adults volunteers

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.

Full Information

NCT ID

NCT03590392

First Posted

June 5, 2018

Last Updated

October 17, 2019

Sponsor

University of Oxford

1. Study Identification

Unique Protocol Identification Number

NCT03590392

Brief Title

Safety and Immunogenicity of a Candidate CHIKV Vaccine (CHIK001)

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

July 31, 2018 (Actual)

Primary Completion Date

September 30, 2019 (Actual)

Study Completion Date

September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chikungunya Fever

Keywords

Vaccine, Chikungunya Virus, Chikungunya Fever

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Group 1 volunteers (n= 6) will be administered ChAdOx1 Chik, 5 x 10^9 vp through intramuscular route.

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Group 2 volunteers (n= 9) will be administered ChAdOx1 Chik, 2.5 x 10^10 vp through intramuscular route.

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Group 3 volunteers (n= 9) will be administered ChAdOx1 Chik, 5 x 10^10 vp through intramuscular route.

Intervention Type

Biological

Intervention Name(s)

ChAdOx1 Chik

Intervention Description

ChAdOx1 Chik, a replication-deficient simian adenoviral vector expressing CHIKV antigens.

Primary Outcome Measure Information:

Title

Occurrence of solicited and unsolicited local and systemic adverse events

Description

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)

Secondary Outcome Measure Information:

Title

Measures of immunogenicity to the ChAdOx1 Chik in healthy adults volunteers

Description

Time Frame

Up to 26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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 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 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 vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccine). 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 Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema. Any history of anaphylaxis in relation 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 likely to affect participation in the study Bleeding disorder (eg. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture Any other serious chronic illness requiring hospital specialist supervision 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) Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis 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 Prior exposure to CHIKV (serology will be requested at the discretion of the investigator) Travel to a CHIKV endemic region throughout the duration of the participants enrolment in the Study and within the preceding 30 days.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adrian V Hill, DPhill FRCP

Organizational Affiliation

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

City

Oxford

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

34330906

Citation

Folegatti PM, Harrison K, Preciado-Llanes L, Lopez FR, Bittaye M, Kim YC, Flaxman A, Bellamy D, Makinson R, Sheridan J, Azar SR, Campos RK, Tilley M, Tran N, Jenkin D, Poulton I, Lawrie A, Roberts R, Berrie E, Rossi SL, Hill A, Ewer KJ, Reyes-Sandoval A. A single dose of ChAdOx1 Chik vaccine induces neutralizing antibodies against four chikungunya virus lineages in a phase 1 clinical trial. Nat Commun. 2021 Jul 30;12(1):4636. doi: 10.1038/s41467-021-24906-y.

Results Reference

derived

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Safety and Immunogenicity of a Candidate CHIKV Vaccine (CHIK001)

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