Safety and Immunogenicity of a Candidate ZIKV Vaccine (ZIKA001)

NCT04015648 | Completed Phase 1 DMC

• 1 other identifier: ZIKA001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 administered intramuscularly.

Conditions

Zika

Keywords

Vaccine

Outcome Measures

Primary Outcomes (4)

• 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).

  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

  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

  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.

  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

  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

  At days 0, 7, 14, 28, 56, 90 and 182 + extended visit days 270 and 360

Study Arms (3)

Group 1

EXPERIMENTAL

Volunteers will receive standalone dose of ChAdOx1 Zika 5 x 10\^9 vp vaccination intramuscularly.

Biological: ChAdOx1 Zika

Group 2

EXPERIMENTAL

Volunteers will receive standalone dose of ChAdOx1 Zika 2.5 x 10\^10 vp vaccination intramuscularly.

Biological: ChAdOx1 Zika

Group 3

EXPERIMENTAL

Volunteers will receive standalone dose of ChAdOx1 Zika 5 x 10\^10 vp vaccination intramuscularly.

Biological: ChAdOx1 Zika

Interventions

ChAdOx1 Zika BIOLOGICAL

Single dose of ChAdOx1 Zika at different concentrations: 5 x 10\^9 vp, 2.5 x 10\^10 vp, 5 x 10\^10 vp

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 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

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 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

CCVTM, University of Oxford, Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Zika Virus Infection

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae 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 4, 2019
• First Posted: July 11, 2019
• Study Start: October 21, 2019
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: May 18, 2022

Record last verified: 2021-11

Locations

GB (1)