Safety and Immunogenicity of a Candidate ZIKV Vaccine (ZIKA001)

May 17, 2022 updated by: University of Oxford

A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Zika Virus (ZIKV) Vaccine ChAdOx1 Zika in Healthy Adult Volunteers.

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 administered intramuscularly.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Volunteers will be recruited and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford. There will be 3 study groups and a total of 24 volunteers will be enrolled. Groups 1-3 will receive ChAdOx1 Zika alone. Staggered enrolment will apply for the first three volunteers within each group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 7LE
        • CCVTM, University of Oxford, Churchill Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 (or providing their medical case summaries)
  • 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 EXCEPT for protein, RNA (or other non-adenovirus based) COVID-19 vaccinations which may be given within 14 days of the trial vaccine.
  • Receipt of recombinant simian adenoviral vaccine prior to enrolment.
  • Planned receipt of another adenoviral vectored vaccine (e.g. Oxford/Astrazeneca or Janssen COVID-19 vaccines) within 90 days after the vaccination with the ChAdOx1 Zika
  • 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)
  • History of confirmed major thrombotic event (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism), history of antiphospholipid syndrome, or history of heparin induced thrombocytopenia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Group 1
Volunteers will receive standalone dose of ChAdOx1 Zika 5 x 10^9 vp vaccination intramuscularly.
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
EXPERIMENTAL: Group 2
Volunteers will receive standalone dose of ChAdOx1 Zika 2.5 x 10^10 vp vaccination intramuscularly.
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
EXPERIMENTAL: Group 3
Volunteers will receive standalone dose of ChAdOx1 Zika 5 x 10^10 vp vaccination intramuscularly.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and tolerability of ChAdOx1 Zika given as a standalone vaccine 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).
Assessment of solicited AEs in the first 7 days post vaccination.
Safety and tolerability of ChAdOx1 Zika given as a standalone vaccine 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
Unsolicited AEs to be assessed up to 28 days post vaccination.
Safety and tolerability of ChAdOx1 Zika given as a standalone vaccine 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
SAEs will be collected from enrolment until the end of the follow-up period (i.e. 6 months)
Safety and tolerability of ChAdOx1 Zika given as a standalone vaccine 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.
At Day 0 (baseline), day 2, day 7 and day 28 post vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measures of humoral immunogenicity to the ChAdOx1 ZIKA vaccine
Time Frame: At days 0, 7, 14, 28, 56, 90 and 182 + extended visit days 270 and 360
ELISA to quantify antibodies to ZIKV protein antigens
At days 0, 7, 14, 28, 56, 90 and 182 + extended visit days 270 and 360
Measures of cellular immunogenicity to the ChAdOx1 ZIKA 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 protein antigens
At days 0, 7, 14, 28, 56, 90 and 182 + extended visit days 270 and 360

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZIKA001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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