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A Study of Intranasal ChAdOx1 nCOV-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04816019
Recruitment Status : Completed
First Posted : March 25, 2021
Last Update Posted : October 24, 2022
Sponsor:
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment Phase
Coronavirus Biological: ChAdOx1 nCov-19 Phase 1

Detailed Description:

The study will include up to 54 healthy adult participants, divided into five groups. Groups 1-3 will consist of vaccine-naïve volunteers and groups 4-5 will consist of volunteers who have received 2 doses of IM COVID-19 vaccine.

Groups 1-3 will receive three vaccine dose levels (low i.e. 5x10^9vp, high i.e. 5x10^10 VP, and moderate i.e. 2x10^10 VP ChAdOx1 nCOV-19 IN). The low and high dose groups will each have safety lead-in subgroups. All volunteers will be consented for receipt of a booster vaccine at approximately 4 weeks post first vaccine. All volunteers will be randomly allocated 1:1 to receive an intranasal booster vaccine as indicated, stratified by first dose level.

Group 4 will consist of volunteers who have received 2 intramuscular doses of ChAdOx1 nCoV-19, at least eight weeks apart, and group 5 will consist of volunteers who have received 2 intramuscular doses of BNT162b, at least three weeks apart. Both of these groups will receive a single standard dose (5x1010vp) on intranasal ChAdOx1 nCOV-19.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase I Study to Determine Safety, Tolerability and Immunogenicity of Intranasal Administration of the COVID Vaccine ChAdOx1 nCOV-19 in Healthy UK Adults
Actual Study Start Date : April 1, 2021
Actual Primary Completion Date : September 30, 2022
Actual Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Experimental: Group 1a: Low Dose

A 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

Biological: ChAdOx1 nCov-19
A single dose of ChAdOx1 nCov-19 delivered intranasally (IN)

Experimental: Group 1b: Low dose

5 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

Biological: ChAdOx1 nCov-19
A single dose of ChAdOx1 nCov-19 delivered intranasally (IN)

Experimental: Group 2a: High Dose

3 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

Biological: ChAdOx1 nCov-19
A single dose of ChAdOx1 nCov-19 delivered intranasally (IN)

Experimental: Group 2b: High Dose

Up 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

Biological: ChAdOx1 nCov-19
A single dose of ChAdOx1 nCov-19 delivered intranasally (IN)

Experimental: Group 3: Intermediate Dose

Up 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

Biological: ChAdOx1 nCov-19
A single dose of ChAdOx1 nCov-19 delivered intranasally (IN)

Experimental: Group 4: High Dose, vaccinated boost
6 volunteers, previously vaccinated with two doses of ChAdOx1 nCoV-19 IM will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 IN.
Biological: ChAdOx1 nCov-19
A single dose of ChAdOx1 nCov-19 delivered intranasally (IN)

Experimental: Group 5: High Dose, vaccinated boost
6 volunteers, previously vaccinated with two doses of BNT162b IM will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 IN.
Biological: ChAdOx1 nCov-19
A single dose of ChAdOx1 nCov-19 delivered intranasally (IN)




Primary Outcome Measures :
  1. Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of solicited signs and symptoms [ Time Frame: 7 days ]
    Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination

  2. Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of unsolicited signs and symptoms [ Time Frame: 28 days ]
    Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination

  3. 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 [ Time Frame: 7 or 35 days ]

    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.


  4. Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of serious adverse events (SAEs) [ Time Frame: 4 months ]
    Occurrence of SAEs and AWESIs collected throughout the trial


Secondary Outcome Measures :
  1. Assess the mucosal immune response to intranasal administration of one or two doses of ChAdOx1 nCov-19 in healthy adult volunteers [ Time Frame: 112 days ]

    Quantification of spike-binding mucosal antibody, collected using SAM strips at D0, D7, D14, D28, D42 (2 dose groups only), D56, D112.

    Includes characterisation of dose-response relationship




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  • True abstinence, when this is in line with the preferred and usual lifestyle of the subject.
  • Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to IMP, and withdrawal are not acceptable methods of contraception

Exclusion Criteria:

  • 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
  • History of antiphospholipid syndrome
  • Prior receipt of unfractionated heparin
  • History of heparin induced thrombocytopenia
  • Any other serious chronic illness requiring hospital specialist supervision.
  • Chronic respiratory diseases, including mild asthma (resolved childhood asthma is allowed).
  • Chronic cardiovascular disease (including hypertension), gastrointestinal disease, liver disease (except Gilberts Syndrome), renal disease, endocrine disorder (including diabetes) and neurological illness (excluding migraine).
  • Nasal pathology (e.g. congenital abnormalities such as an abnormal septum or polyps, previous cauterisation, rhinoplasty or nasal surgery of any kind, recurrent epistaxis).
  • Seriously overweight (BMI≥40 Kg/m2) or underweight (BMI≤18 Kg/m2).
  • 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.
  • Any clinically significant abnormal finding on screening biochemistry, haematology blood tests or urinalysis.
  • 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.
  • Groups 1, 2 and 3 only: Living in the same household as any vulnerable groups at risk of severe COVID-19 disease (as per PHE guidance).
  • Groups 1, 2 and 3 only: Membership of any group identified by JCVI at the time of enrolment as being eligible for priority vaccination (i.e. ahead of the typical member of the individual's age cohort).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816019


Locations
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United Kingdom
CCVTM, University of Oxford, Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: Alexander Douglas, Dr University of Oxford
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04816019    
Other Study ID Numbers: COV008
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: October 24, 2022
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Covid-19
ChAdOx1 nCov19
SARS-CoV-2
Vaccine
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Infections