Investigating a new Vaccine Against Meningitis B (in Oxford)
- Conditions
- Meningitis BInfections and InfestationsNeisseria meningitidis serotype B
- Registration Number
- ISRCTN46336916
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 88
1. Willing and able to give written informed consent for participation in the study
2. Aged between 18 and 50 years inclusive at the time of first vaccination
3. In good health as determined by
3.1. Medical history
3.2. Physical examination
3.3. Clinical judgment of the investigators
4. (Females of childbearing potential) Willing to use effective contraception (such as the oral contraceptive pill, contraceptive implant, barrier methods or complete abstinence from heterosexual sexual intercourse) from one month prior to first vaccination and for three months following last vaccine
5. Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of diary cards
6. Willing to allow his or her General Practitioner to be notified of participation in the study
7. Confirmation from the participants GP that they are satisfied from their knowledge of the volunteer that they are suitable to enrol and/or the provision of a detailed medical summary is provided to the study team to assess participant eligibility
8. Agrees to refrain from donating blood for the duration of the trial
9. Agree to be registered on the Trial Over-Volunteering Prevention Service (TOPS) and agree to provide their National Insurance number or passport number (if not a British citizen) for the purposes of registration
10. Agree to provide National Insurance number and Bank details for reimbursement purposes
Participant exclusion criteria as of 31/10/2018:
1. History of significant organ/system disease that could interfere with trial conduct or completion. This includes any history of significant disease in the following;
1.1. Cardiovascular disease including congenital heart disease, previous myocardial infarction, valvular heart disease (or history of rheumatic fever), previous bacterial endocarditis, history of cardiac surgery (including pacemaker insertion), personal or family history of cardiomyopathy or sudden adult death
1.2. Respiratory disease such as uncontrolled asthma and chronic obstructive pulmonary disease
1.3. Endocrine disorders such as diabetes mellitus and Addison’s disease
1.4. Significant renal or bladder disease, including history of renal calculi
1.5. Biliary tract disease
1.6. Gastro-intestinal disease such as inflammatory bowel disease, abdominal surgery within the last two years, coeliac disease and liver disease (including hepatitis B or C infection)
1.7. Neurological disease such as seizures and myasthenia gravis
1.8. Haematological problems such as anaemia or coagulation problems
1.9. Metabolic disease such as glucose-6-phosphate dehydrogenase deficiency
1.10. Psychiatric illness requiring hospitalisation or depression whose severity is deemed clinically significant by the study Investigators and/or GP
1.11. Known or suspected drug and/or alcohol misuse (alcohol misuse defined as an intake exceeding 42 units per week)
1.12. Non-benign cancer, except squamous cell or basal cell carcinoma of the skin and cervical carcinoma in situ
2. History of allergy or anaphylaxis to a vaccine or any component within the vaccines used in this study
3. Have any known or suspected impairment or alteration of immune function, resulting from, for example:
3.1. Congenital or acquired immunodeficiency
3.2. Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition
3.3. Autoimmune disease
3.4. Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy
4. Study significant abnormalities on screening investigations at the discretion of an Investigator
5. Weight < 50 kg
6. Donation of blood within the last 3 (male) or 4 (female) months) or plans on giving blood within the next year
7. Receipt of a live vaccine within 4 weeks prior to vaccination, an inactivated influenza vaccine within 14 days of vaccination or another inactivated vaccine within 7 days prior to vaccination
8. Plan to receive any vaccine other than the study vaccine within 4 weeks following vaccination
9. Scheduled procedures requiring general anaesthesia during the study
10. Receipt of immunoglobulin or any blood product transfusion within 3 months of study start
11. Current active participation in another research study involving an investigational product or where involvement in this study could impact the results
12. Donation of blood in the past 12 weeks (if male) or 16 weeks (if female), or are planning to do so within the 52 weeks of vaccination in this study
13. Previously having received a meningococcal B vaccine of any kind
14. Previously having received a meningococcal ACWY vaccine in the last 10 years (groups 7 and 8)
15. Previously having received a meningococcal C vaccine in the last 10 years (groups 7 and 8)
16. Previously received any adenovirus based vaccine of any kind (usually as part of a trial) (Grou
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Solicited symptoms the participants record following each vaccination in a diary records from Day 0 (day of vaccination) to Day 7 (plus later if any persisting symptoms). The recording and assessment of local and systemic adverse events following administration of each vaccine dose:<br>1.1. Tenderness and pain at the injection site<br>1.2. Induration<br>1.3. Redness<br>1.4. Swelling<br>1.5. Headache<br>1.6. Malaise<br>1.7. Myalgia<br>1.8. Nausea and/or vomiting<br>1.9. Anorexia<br>1.10. Fever<br>1.11. Arthralgia<br>1.12. Blood parameters<br>2. Unsolicited adverse events up until and including 28 days following the last vaccine<br>3. Serious adverse events (SAEs) during the entire study<br>4. Safety is measured using blood tests at all study visits
- Secondary Outcome Measures
Name Time Method