Understanding the Immune Response to Two Different Meningitis Vaccines
Meningitis, Meningococcal Disease, Septicaemia
About this trial
This is an interventional basic science trial for Meningitis focused on measuring Vaccines, Meningitis, Meningococcal
Eligibility Criteria
Inclusion Criteria:
Participants must meet the following conditions in order to be enrolled:
- Between 30 and 70 years of age inclusive;
- Willing and able to give informed consent for participation after the nature of the study has been explained;
- In good health as determined by:
medical history history-directed physical examination clinical judgment of the investigator
- Able (in the Investigators opinion) and willing to comply with all study requirements including be available for all the visits scheduled in the study;
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion Criteria:
Participants with any of the following conditions or characteristics will be excluded from study enrolment:
- Prior receipt of a meningococcal vaccine;
- Prior laboratory confirmed disease caused by N meningitides;
- Prior history of any anaphylactic shock, asthma, urticarial or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
Known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):
- Receipt of immunostimulants
- Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding year or long-term systemic corticosteroid therapy (prednisolone or equivalent for more than two consecutive weeks within the past 3 months).
- Suspected or known HIV infection or HIV related disease;
- Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months
- Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
- Any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
- Participation in another clinical trial investigating a vaccine, a drug, a medical device, or a medical procedure;
- Pregnancy as confirmed by a positive pregnancy test ;
- Concurrent breast-feeding.
Sites / Locations
- Oxford Vaccine Group
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
Group 1 Conjugate-conjugate
Group 2 Polysaccharide-conjugate
Group 3 Polysaccharide (subcutaneously)-conjugate
Group 4: 1/5th dose Polysaccharide:conjugate
Group I will receive 2 doses of the MenACWY-CRM conjugate vaccine (Novartis Vaccines) given 1 month apart. All vaccine doses are 0.5ml and will be administered intramuscularly into the deltoid.
Group II will receive one full dose of MenACWY-PS polysaccharide vaccine meningococcal vaccine, followed by one dose of MenACWY-CRM conjugate vaccine given 1 month later. 0.5 mL of MenACWY-PS vaccine will be administered subcutaneously and 0.5 mL of the MenACWY-CRM vaccine will be administered intramuscularly into the deltoid.
Group III will receive a full dose of MenACWY-PS polysaccharide vaccine meningococcal vaccine subcutaneously, followed by one dose of MenACWY-CRM conjugate vaccine given 1 month later.
Group IV will receive one fifth dose of MenACWY-PS polysaccharide vaccine meningococcal vaccine, followed by one dose of MenACWY-CRM conjugate vaccine given 1 month later. 0.1 mL of MenACWY-PS vaccine will be administered IM and 0.5 mL of the MenACWY-CRM vaccine will be administered intramuscularly into the deltoid.