Safety and Immunogenicity of a Candidate CHIKV Vaccine (CHIK001)

NCT03590392 | Completed Phase 1

• 1 other identifier: CHIK001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Chikungunya Fever

Keywords

Vaccine; Chikungunya Virus; Chikungunya Fever

Outcome Measures

Primary Outcomes (1)

• Occurrence of solicited and unsolicited local and systemic adverse events

  Occurrence of solicited and unsolicited local and systemic adverse events

  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 Outcomes (1)

• Measures of immunogenicity to the ChAdOx1 Chik in healthy adults volunteers

  Up to 26 weeks

Study Arms (3)

Group 1

EXPERIMENTAL

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

Biological: ChAdOx1 Chik

Group 2

EXPERIMENTAL

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

Biological: ChAdOx1 Chik

Group 3

EXPERIMENTAL

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

Biological: ChAdOx1 Chik

Interventions

ChAdOx1 Chik BIOLOGICAL

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

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Oxford, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34330906 DERIVED

MeSH Terms

Conditions

Chikungunya Fever

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Study Officials

• Adrian V Hill, DPhill FRCP

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: July 18, 2018
• Study Start: July 31, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: October 18, 2019

Record last verified: 2019-07

Locations

GB (1)