A phase II study of a candidate COVID-19 vaccine in children (COV006)
- Conditions
- Prevention of COVID-19 infection in childrenInfections and InfestationsCOVID-19 (SARS-CoV-2 infection)
- Registration Number
- ISRCTN15638344
- Lead Sponsor
- niversity of Oxford
- Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35691324/ (added 13/06/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 262
1. Healthy child or adolescent aged 6-17 years (upper age limit is 17 years and 8 months so that both prime and booster are expected to take place prior to their 18th birthday)
2. Able and willing (in the Investigator’s opinion) to comply with all study requirements (participant’s parents/guardians must not rely on public transport or taxis)
3. Willing to allow the investigators to discuss the participant’s medical history with their General Practitioner and access all medical records when relevant to study procedures
4. Parent/guardian to provide informed consent for participants under the age of 16; it will be assumed that participants aged 16 and over are able to provide consent for themselves, however parental support will be sought and investigators will reserve the right to refuse enrollment if concerns arise
1. History of laboratory confirmed COVID-19 (A positive result on a validated test for SARS-CoV-2 or seropositivity for SARS-CoV-2 before enrolment)
2. Chronic respiratory diseases, including mild asthma (resolved childhood asthma is allowed)
3. Prior receipt of MenB vaccine
4. Prior receipt of any vaccines (licensed or investigational) =30 days before enrolment
5. Planned receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination
6. 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)
7. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
8. 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)
9. Any autoimmune conditions,
10. History of allergic disease or reactions likely to be exacerbated by any component of the ChAdOx1 nCoV-19 or MenB vaccines
11. Previous diagnosis of Kawasaki disease
12. Any history of angioedema
13. Any history of anaphylaxis
14. Pregnancy, lactation or willingness/intention to become pregnant during the study
15. Any history of cancer
16. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
17. Any other serious chronic illness requiring hospital specialist supervision
18. Congenital cardiovascular conditions
19. Any other significant disease, disorder or finding which may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study or impair interpretation of the study data
20. Child of a staff member of the Oxford Vaccine Group
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To assess the local reactogenicity profile and tolerability of ChAdOx1 nCoV (5.0 x1010vp /5.0 x1010vp) given as a homologous prime boost schedules (28 and 84 days interval post prime) in children aged 6-17 years<br>1.1. Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination<br>1.2. Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination<br>2. To determine the safety of the candidate ChAdOx1 nCoV-19 in children aged 6 - 17 years<br>2.1. Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination<br>2.2. Occurrence of SAEs and disease enhancement episodes over course of study<br>2.3. Occurrence of serious adverse events (SAEs) throughout study duration
- Secondary Outcome Measures
Name Time Method 1. To assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 (5.0 x1010vp /5.0 x1010vp) given as homologous prime boost (at 28 and 84 days post prime) in children aged 6-17 years<br>At Days 0, 28, 56, 84, 112, 182 and 364:<br>1.1. Quantify antibodies against SARS-CoV-2 spike protein<br>1.2. Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus<br>1.3. Interferon-gamma (IFN-?) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein<br>1.4. Cell analysis by flow cytometry assays