ZikaPhase 1NCT04015648
Safety and Immunogenicity of a Candidate ZIKV Vaccine (ZIKA001)
A Phase 1 study testing ChAdOx1 Zika in people with Zika, run by University of Oxford at 1 site in United Kingdom.
Trial 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 administered intramuscularly. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Zika
- What is being tested?
- ChAdOx1 Zika
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Oct 2019to 10 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
CCVTM, University of Oxford, Churchill Hospital
Oxford, OX3 7LE
About this study
Official title: 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.
Read the 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.
- Conditions
- Zika
- Being tested
- ChAdOx1 Zika
- Keywords
- Vaccine
- Medical subject headings
- Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdOx1 ZikaBiological
Single dose of ChAdOx1 Zika at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Volunteers will receive standalone dose of ChAdOx1 Zika 5 x 10^9 vp vaccination intramuscularly. Receives: Biological: ChAdOx1 Zika |
| Group 2 | Experimental | Volunteers will receive standalone dose of ChAdOx1 Zika 2.5 x 10^10 vp vaccination intramuscularly. Receives: Biological: ChAdOx1 Zika |
| Group 3 | Experimental | Volunteers will receive standalone dose of ChAdOx1 Zika 5 x 10^10 vp vaccination intramuscularly. Receives: Biological: ChAdOx1 Zika |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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).
Measured: 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.
Occurrence of unsolicited local and systemic adverse events
Measured: 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.
Occurrence of serious adverse events
Measured: 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.
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.
Measured: At Day 0 (baseline), day 2, day 7 and day 28 post vaccination
Secondary outcomes (2)
Measures of humoral immunogenicity to the ChAdOx1 ZIKA vaccine
ELISA to quantify antibodies to ZIKV protein antigens
Measured: 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
Ex vivo interferon gamma ELISpot responses to ZIKV protein antigens
Measured: At days 0, 7, 14, 28, 56, 90 and 182 + extended visit days 270 and 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start21 Oct 2019
- Primary completion10 Mar 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ZikaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian V Hill, DPhill FRCP, Principal investigator, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015648
- Sponsor's protocol ID
- ZIKA001
- Status last verified
- Nov 2021
- First submitted
- 4 Jun 2019
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Zika Virus (ZIKV) Vaccine ChAdOx1 Zika in Healthy Adult Volunteers.
- ClinicalTrials.gov ID
- NCT04015648
- Acronym / sponsor ID
- ZIKA001
- Conditions
- Zika
- Keywords
- Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: ChAdOx1 ZikaVolunteers will receive standalone dose of ChAdOx1 Zika 5 x 10^9 vp vaccination intramuscularly. |
| Group 2 | Experimental | Biological: ChAdOx1 ZikaVolunteers will receive standalone dose of ChAdOx1 Zika 2.5 x 10^10 vp vaccination intramuscularly. |
| Group 3 | Experimental | Biological: ChAdOx1 ZikaVolunteers will receive standalone dose of ChAdOx1 Zika 5 x 10^10 vp vaccination intramuscularly. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChAdOx1 ZikaSingle dose of ChAdOx1 Zika at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp | Biological | Group 1, Group 2, Group 3 |
Primary outcome
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).
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
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
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian V Hill, DPhill FRCP principal investigator
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ChAdOx1 Zika in people with Zika, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.