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NCT01593514

PHASE4

Understanding the Immune Response to Two Different Meningitis Vaccines

Sponsor: University of Oxford

View on ClinicalTrials.gov

Summary

The bacterium (germ) Neisseria meningitidis causes meningitis and blood poisoning. N meningitidis is classified into different serogroups (types), based on its outer polysaccharide (carbohydrate) capsule. Serogroups A,B,C,W \& Y are responsible for the vast majority of meningococcal disease worldwide. Older vaccines against types A,C,W \& Y contain part of the polysaccharide capsule of the germ. However, these polysaccharide vaccines do not provide long-term protection against disease and are less effective in young children, the group most at risk of meningococcal disease. Newer "conjugate" ACWY vaccines attach a polysaccharide to a protein carrier - these provoke a good response in young children and can provide long-term protection. White blood cells called B cells produce antibodies, which are the main components of protection against meningococcal disease. Although many studies have investigated the immune response to these vaccines in different age groups by measuring specific antibodies, there is limited information about the B cells underlying such an immune response. Several different subsets (populations) of B cells exist in the blood. Previous studies by the investigators group suggest that different numbers of B cells are produced in response to each vaccine type. However, little is understood about which subset of B cell is important for antibody production in response to these polysaccharide or conjugate vaccines. This study aims to provide detailed information on the immune response to meningococcal vaccines by investigating the appearance of B cells and their subsets in the blood after vaccination with the polysaccharide and conjugate vaccines. These observations will help us understand how polysaccharide and conjugate vaccines stimulate the immune system in different ways. This knowledge will help in the development of new vaccines that are effective across all age groups. The investigators aim to recruit 20 adults aged 30-70 from Oxfordshire. The study will be funded by the Oxford Vaccine Group.

Official title: A Single Centre, Open-label, Randomised Clinical Study to Investigate Meningococcal Serogroup A and C Saccharide Specific B Cell Responses in Adult Volunteers to One of Three Regimens of Meningococcal ACWY Conjugate Vaccine or Meningococcal ACWY Polysaccharide Vaccine Priming Doses Followed by a Booster Dose of the Meningococcal ACWY Conjugate Vaccine

Key Details

Gender

All

Age Range

30 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2012-12

Completion Date

2013-04

Last Updated

2026-05-04

Healthy Volunteers

Yes

Conditions

Meningitis Meningococcal Disease Septicaemia

Interventions

BIOLOGICAL

MenACWY-CRM conjugate vaccine (Menveo, Novartis)

The MenACWY-CRM conjugate vaccine (Menveo, Novartis) is obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be reconstituted with the MenCWY component. This vaccine is to be administered intramuscularly.

BIOLOGICAL

MenACWY-PS polysaccharide vaccine, ( ACWYVax, GSK) and MenACWY-CRM conjugate vaccine (Menveo, Novartis)

The MenACWY-PS polysaccharide vaccine, ( ACWYVax, GSK) is obtained by reconstituting the purified ACWY polysaccharides with the 0.5 ml water for injection. This vaccine should be administered subcutaneously.The MenACWY-CRM conjugate vaccine (Menveo, Novartis) is obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be reconstituted with the MenCWY component. This vaccine is to be administered intramuscularly.

BIOLOGICAL

MenACWY-PS polysaccharide vaccine, ( ACWYVax, GSK) and MenACWY-CRM conjugate vaccine (Menveo, Novartis)

BIOLOGICAL

1/5th dose MenACWY-PS polysaccharide vaccine, ( ACWYVax, GSK) and MenACWY-CRM conjugate vaccine (Menveo, Novartis)

To obtain the one-fifth dose of MenACWY-PS, 0.5ml of a full dose of MenACWY-PS will be reconstituted, and then 0.4ml will be discarded prior to subcutaneous injection. The MenACWY-CRM conjugate vaccine (Menveo, Novartis) is obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be reconstituted with the MenCWY component. This vaccine is to be administered intramuscularly.

BIOLOGICAL

Polysaccharide (subcutaneously)-conjugate

The MenACWY-PS polysaccharide vaccine, ( ACWYVax, GSK) is obtained by reconstituting the purified ACWY polysaccharides with the 0.5 ml water for injection.The MenACWY-CRM conjugate vaccine (Menveo, Novartis) is obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be reconstituted with the MenCWY component. This vaccine is to be administered subcutaneously

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.

Locations (1)

Oxford Vaccine Group

Oxford, Oxfordshire, United Kingdom

Clinical Research Directory

Understanding the Immune Response to Two Different Meningitis Vaccines

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)