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Safety and Immunogenicity of a Candidate ZIKV Vaccine (ZIKA001)

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ClinicalTrials.gov Identifier: NCT04015648
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE June 4, 2019
First Posted Date  ICMJE July 11, 2019
Last Update Posted Date April 14, 2021
Actual Study Start Date  ICMJE October 21, 2019
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2020)
  • Safety and tolerability of ChAdOx1 Zika given as a standalone vaccine or co-administered with ChAdOx1 Chik at different doses in healthy adult volunteers assessed by the occurrence of solicited adverse events. [ Time Frame: Assessment of solicited AEs in the first 7 days post vaccination. ]
    Occurrence of solicited local and systemic adverse events (i.e: pain, redness, swelling and pruritus at injection site and temperature, feverishness, myalgia, arthralgia, malaise, headache and nausea).
  • Safety and tolerability of ChAdOx1 Zika given as a standalone vaccine or co-administered with ChAdOx1 Chik at different doses in healthy adult volunteers assessed by the occurrence of unsolicited adverse events. [ Time Frame: Unsolicited AEs to be assessed up to 28 days post vaccination. ]
    Occurrence of unsolicited local and systemic adverse events
  • Safety and tolerability of ChAdOx1 Zika given as a standalone vaccine or co-administered with ChAdOx1 Chik at different doses in healthy adult volunteers assessed by the occurrence of serious adverse events. [ Time Frame: SAEs will be collected from enrolment until the end of the follow-up period (i.e. 6 months) ]
    Occurrence of serious adverse events
  • Safety and tolerability of ChAdOx1 Zika given as a standalone vaccine or co-administered with ChAdOx1 Chik at different doses in healthy adult volunteers assessed by the occurrence of laboratory adverse events. [ Time Frame: At Day 0 (baseline), day 2, day 7 and day 28 post vaccination ]
    Occurrence of laboratory adverse events defined as clinically significant changes from baseline. Haematology (Full Blood Count) and Biochemistry (Kidney and Liver Function Tests) will be assessed.
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Safety and tolerability of ChAdOx1 Zika given as a standalone vaccine or co-administered with ChAdOx1 Chik at different doses in healthy adult volunteers assessed by the occurrence of solicited adverse events. [ Time Frame: Assessment of solicited AEs in the first 7 days post vaccination. ]
    Occurrence of solicited local and systemic adverse events (i.e: pain, redness, swelling and pruritus at injection site and temperature, feverishness, myalgia, arthralgia, malaise, headache and nausea).
  • Safety and tolerability of ChAdOx1 Zika given as a standalone vaccine or co-administered with ChAdOx1 Chik at different doses in healthy adult volunteers assessed by the occurrence of unsolicited adverse events. [ Time Frame: Unsolicited AEs to be assessed up to 28 days post vaccination. ]
    Occurrence of unsolicited local and systemic adverse events
  • Safety and tolerability of ChAdOx1 Zika given as a standalone vaccine or co-administered with ChAdOx1 Chik at different doses in healthy adult volunteers assessed by the occurrence of serious adverse events. [ Time Frame: SAEs will be collected from enrolment until the end of the follow-up period (i.e. 12 months) ]
    Occurrence of serious adverse events
  • Safety and tolerability of ChAdOx1 Zika given as a standalone vaccine or co-administered with ChAdOx1 Chik at different doses in healthy adult volunteers assessed by the occurrence of laboratory adverse events. [ Time Frame: At Day 0 (baseline), day 2, day 7 and day 28 post vaccination ]
    Occurrence of laboratory adverse events defined as clinically significant changes from baseline. Haematology (Full Blood Count) and Biochemistry (Kidney and Liver Function Tests) will be assessed.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2021)
  • Measures of humoral immunogenicity to the ChAdOx1 ZIKA and ChAdOx1 CHIK vaccines [ Time Frame: At days 0, 7, 14, 28, 56, 90 and 182 + extended visit days 270 and 360 ]
    ELISA to quantify antibodies to ZIKV and CHIKV protein antigens responses to ZIKV and CHIKV protein antigens
  • Measures of cellular immunogenicity to the ChAdOx1 ZIKA and ChAdOx1 CHIK vaccines [ Time Frame: At days 0, 7, 14, 28, 56, 90 and 182 + extended visit days 270 and 360 ]
    Ex vivo interferon gamma ELISpot responses to ZIKV and CHIKV protein antigens
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Measures of humoral immunogenicity to the ChAdOx1 ZIKA and ChAdOx1 CHIK vaccines [ Time Frame: At days 0, 7, 14, 28, 90, 182, 270 and 364 ]
    ELISA to quantify antibodies to ZIKV and CHIKV protein antigens responses to ZIKV and CHIKV protein antigens
  • Measures of cellular immunogenicity to the ChAdOx1 ZIKA and ChAdOx1 CHIK vaccines [ Time Frame: At days 0, 7, 14, 28, 90, 182, 270 and 364 ]
    Ex vivo interferon gamma ELISpot responses to ZIKV and CHIKV protein antigens
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 ZIKV Vaccine (ZIKA001)
Official Title  ICMJE A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Zika Virus (ZIKV) Vaccine ChAdOx1 Zika in Healthy Adult Volunteers Given as a Standalone Vaccine or Co-administered With the Chikungunya Virus (CHIKV) Candidate Vaccine ChAdOx1 Chik
Brief Summary This is a FIH, open-label, dose escalation, phase I clinical trial to assess the safety and immunogenicity of the candidate ChAdOx1 Zika vaccine in healthy volunteers given as a standalone vaccine or in coadministration with ChAdOx1 Chik. Both vaccines will be administered intramuscularly.
Detailed Description Volunteers will be recruited and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford. There will be 6 study groups and a total of 48 volunteers will be enrolled. Groups 1-3 will receive ChAdOx1 Zika alone. Groups 4-6 will receive a co-administration of ChAdOx1 Zika and ChAdOx1 Chik administered contralaterally. Staggered enrolment will apply for the first three volunteers within each group.
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
  • Zika
  • Chikungunya
Intervention  ICMJE
  • Biological: ChAdOx1 Zika
    Single dose of ChAdOx1 Zika at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp
  • Biological: ChAdOx1 Zika, ChAdOx1 Chik
    Co-administration of ChAdOx1 Zika and ChAdOx1 Chik at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp
Study Arms  ICMJE
  • Experimental: Group 1
    Volunteers will receive standalone dose of ChAdOx1 Zika 5 x 10^9 vp vaccination intramuscularly.
    Intervention: Biological: ChAdOx1 Zika
  • Experimental: Group 2
    Volunteers will receive standalone dose of ChAdOx1 Zika 2.5 x 10^10 vp vaccination intramuscularly.
    Intervention: Biological: ChAdOx1 Zika
  • Experimental: Group 3
    Volunteers will receive standalone dose of ChAdOx1 Zika 5 x 10^10 vp vaccination intramuscularly.
    Intervention: Biological: ChAdOx1 Zika
  • Experimental: Group 4
    Volunteers will receive co-administration dose of ChAdOx1 Zika 5 x 10^9 vp vaccination and ChAdOx1 Chik 5 x 10^9 vp intramuscularly.
    Intervention: Biological: ChAdOx1 Zika, ChAdOx1 Chik
  • Experimental: Group 5
    Volunteers will receive co-administration dose of ChAdOx1 Zika 2.5 x 10^10 vp vaccination and ChAdOx1 Chik 2.5 x 10^10 vp intramuscularly.
    Intervention: Biological: ChAdOx1 Zika, ChAdOx1 Chik
  • Experimental: Group 6
    Volunteers will receive co-administration dose of ChAdOx1 Zika 5 x 10^10 vp vaccination and ChAdOx1 Chik 5 x 10^10 vp intramuscularly.
    Intervention: Biological: ChAdOx1 Zika, 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2021)
48
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2019)
57
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 or access to this medical history electronically.
  • Women of child-bearing potential agree to practice continuous effective contraception (see below) during the study and test negative for pregnancy on the day(s) of screening and vaccination.
  • Agreement to refrain from blood donation during the course of the study
  • Agreement to inform study team of any impending vaccinations either before or during participation in the study.
  • Agreement to refrain from receipt of any flavivirus vaccine throughout the duration of the study (e.g. investigational or licensed Yellow Fever, Japanese Encephalitis, Tick Borne Encephalitis or Dengue virus vaccines).
  • 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 or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccine, Zika virus vaccine, Dengue virus vaccine).
  • Prior receipt of any vaccines administered ≤30 days before enrolment and/or planned receipt of a vaccine ≤30 days after 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. Any history of anaphylaxis in relation to vaccination.
  • History of autoimmune disease.
  • Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
  • 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 (e.g. 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
  • Has history of chronic or acute severe neurologic condition. Including: Neurologic and Neuroinflammatory Disorders: ADEM, including site specific variants, Cranial Nerve Disorders (including paralyses/paresis), GBS (including Miller Fisher Syndrome and other variants), Immune-mediated Peripheral Neuropathies and Plexopathies, Optic Neuritis, Multiple Sclerosis, Narcolepsy, Transverse Myelitis, meningitis, or meningoencephalitis.
  • 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 or access this medical history electronically.
  • Seropositivity or cross-reactivity to Zika virus or Dengue virus (serology will be requested at the discretion of the investigator).
  • Travel to a Zika virus and/or Dengue virus, endemic region in the 30 days prior to screening, until enrolment and in the first 6 months of the participants enrolment in the study (consult clinical team regarding international travel plans)

Additional Exclusion Criteria for Participants also Receiving ChAdOx1 Chik (Groups 4-6)

  • Prior exposure to CHIKV (serology will be requested at the discretion of the investigator).
  • Prior receipt of an experimental CHIKV vaccine (serology will be requested at the discretion of the investigator).
  • Travel to a CHIKV endemic region in the preceding 30 days before screening, until enrolment and in the first 6 months of the participants enrolment in the study (consult clinical team regarding international travel plans)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Volunteer Recruitment Co-ordinator Volunteer Recruitment Co-ordinator 01865 611424 vaccinetrials@ndm.ox.ac.uk
Contact: Adrian V Hill, DPhill FRCP
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04015648
Other Study ID Numbers  ICMJE ZIKA001
Has Data Monitoring Committee Yes
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 April 2021

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