A Study of Intranasal ChAdOx1 nCOV-19
A Phase I Study to Determine Safety, Tolerability and Immunogenicity of Intranasal Administration of the COVID Vaccine ChAdOx1 nCOV-19 in Healthy UK Adults
1 other identifier
interventional
42
1 country
1
Brief Summary
Open label, dose escalation study to investigate:
- 1.Safety, tolerability and immunogenicity of one or two doses of intranasal ChAdOx1 nCOV-19, in vaccine naïve individuals, with randomisation between one and two dose groups.
- 2.Safety, tolerability and immunogenicity of intranasal ChAdOx1 nCOV-19, given as a booster dose in individuals who have had two intramuscular COVID-19 vaccinations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2021
CompletedFirst Posted
Study publicly available on registry
March 25, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedOctober 24, 2022
November 1, 2021
1.5 years
March 15, 2021
October 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of solicited signs and symptoms
Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination
7 days
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of unsolicited signs and symptoms
Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
28 days
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of adverse events as identified by change in baseline safety laboratory measures
Change from baseline for safety laboratory measures (hematology and biochemistry) at Day 7 (and Day 35 for 2 dose groups only). Safety laboratory measures include clinical blood tests for full blood count, liver function and renal function as graded on a predetermined toxicity grading scale.
7 or 35 days
Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of serious adverse events (SAEs)
Occurrence of SAEs and AWESIs collected throughout the trial
4 months
Secondary Outcomes (1)
Assess the mucosal immune response to intranasal administration of one or two doses of ChAdOx1 nCov-19 in healthy adult volunteers
112 days
Study Arms (7)
Group 1a: Low Dose
EXPERIMENTALA single, Covid-19 vaccine naive volunteer will receive a single dose of 5x10\^9vp ChAdOx1 nCOV-19 IN. Volunteers in Group 1a \& b will be randomized to receive booster dose of 5 x 10\^9vp ChAdOx1 IN or no booster
Group 1b: Low dose
EXPERIMENTAL5 Covid-19 vaccine naive volunteers will receive a single dose of 5x10\^9vp ChAdOx1 nCOV-19 IN. Volunteers in Group 1a \& b will be randomized to receive booster dose of 5 x 10\^9vp ChAdOx1 IN or no booster
Group 2a: High Dose
EXPERIMENTAL3 Covid-19 vaccine naivevolunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCOV-19 IN. Volunteers in Group 2a \& b will be randomized to receive booster dose of 5 x 10\^10vp ChAdOx1 IN or no booster
Group 2b: High Dose
EXPERIMENTALUp to 15 Covid-19 vaccine naive volunteers will receive a single dose of 5x10\^10vp ChAdOx1 nCOV-19 IN. Volunteers in Group 2a \& b will be randomized to receive booster dose of 5 x 10\^10vp ChAdOx1 IN or no booster
Group 3: Intermediate Dose
EXPERIMENTALUp to 18 Covid-19 vaccine naive volunteers will receive a single dose of 2x10\^10vp ChAdOx1 nCOV-19 IN. Volunteers will be randomized to receive booster dose of 2 x 10\^10vp ChAdOx1 IN or no booster
Group 4: High Dose, vaccinated boost
EXPERIMENTAL6 volunteers, previously vaccinated with two doses of ChAdOx1 nCoV-19 IM will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 IN.
Group 5: High Dose, vaccinated boost
EXPERIMENTAL6 volunteers, previously vaccinated with two doses of BNT162b IM will receive a single dose of 5x10\^10vp ChAdOx1 nCoV-19 IN.
Interventions
A single dose of ChAdOx1 nCov-19 delivered intranasally (IN)
Eligibility Criteria
You may qualify if:
- Groups 1, 2 and 3 only: Healthy adults aged 18-55 years (Note, prior to implementation of SA001, a single participant under the age of 30 was enrolled in group 1a. This participant will be retained for follow-up but will not receive a booster vaccine, in light of the new age restrictions. Between the implementation of SA001 and implementation of SA003, only those aged 30-40 years were eligible.
- Groups 4 and 5 only: Healthy adults aged 30-55 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 and access all medical records when relevant to study procedures.
- For females only, willingness to practice continuous effective contraception 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.
- Group 4 only: Prior receipt of 2 doses of ChAdOx1 nCoV-19 intramuscularly, with an interval of at least 8 weeks between the intramuscular doses, and with the second dose a minimum of 12 weeks prior to enrolment
- Group 5 only: Prior receipt of 2 doses of BNT162b2 intramuscularly, with an interval of at least 3 weeks between the intramuscular doses, and with the second dose a minimum of 12 weeks prior to enrolment
- Acceptable forms of contraception for female volunteers include:
- Established use of oral, injected or implanted hormonal methods of contraception.
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Total abdominal hysterectomy.
- Bilateral tubal Occlusion Barrier methods of contraception (condom or occlusive cap with spermicide).
- Male sterilisation, if the vasectomised partner is the sole partner for the subject.
- +2 more criteria
You may not qualify if:
- Receipt or planned receipt of any vaccine other than the study intervention within 28 days before and after each study vaccination.
- Participation in COVID-19 prophylactic drug trials for the duration of the study. (Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalisation due to COVID-19. The study team should be informed as soon as possible.)
- Groups 1, 2 and 3 only: Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines).
- 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 use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting \<14 days).
- Any autoimmune conditions, except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy.
- History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV-19.
- Any history of angioedema.
- Any history of anaphylaxis.
- 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 any organic central nervous system disorder or any functional disorder involving neurological symptoms
- History of serious psychiatric condition likely to affect participation in the study (e.g. ongoing severe depression, history of admission to an in-patient psychiatric facility, recent suicidal ideation, history of suicide attempt, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication).
- Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture, or continuous anticoagulation e.g. with warfarin
- History of confirmed major thrombotic event (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism), or
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CCVTM, University of Oxford, Churchill Hospital
Oxford, OX3 7LE, United Kingdom
Related Publications (1)
Nakahashi-Ouchida R, Fujihashi K, Kurashima Y, Yuki Y, Kiyono H. Nasal vaccines: solutions for respiratory infectious diseases. Trends Mol Med. 2023 Feb;29(2):124-140. doi: 10.1016/j.molmed.2022.10.009. Epub 2022 Nov 23.
PMID: 36435633DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Douglas, Dr
University of Oxford
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2021
First Posted
March 25, 2021
Study Start
April 1, 2021
Primary Completion
September 30, 2022
Study Completion
September 30, 2022
Last Updated
October 24, 2022
Record last verified: 2021-11