Meningococcal Infections Clinical Trial
Official title:
Investigating Meningococcal Vaccines in Adults - An Exploratory, Open-label, Immunogenicity Study of a Licensed Meningococcal Capsular Group B Vaccine (4CMenB, Bexsero®) in Adults
NCT number | NCT02398396 |
Other study ID # | OVG 2014/12 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | June 13, 2019 |
Verified date | October 2018 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will be an open label, exploratory immunogenicity study conducted by the Oxford Vaccine Group, University of Oxford. This study will investigate the breadth of protective activity of serum anti-FHbp antibody responses of adults immunized with 4CMenB (Bexsero®) vaccine as well as investigating the nature of the B-cell and T-cell responses induced by vaccination. The investigators aim to enroll 15 to 20 healthy adults aged 18 to 60, who will be immunized with two doses of 4CMenB (Bexsero®) two months apart according to the licensed schedule. Blood samples will be obtained at baseline and after each dose of vaccine.
Status | Completed |
Enrollment | 15 |
Est. completion date | June 13, 2019 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Participant is willing and able to give informed consent for participation in the study. - Male or Female, aged 18 years to 60 years inclusive on the day of first vaccination. - To be in good health as determined by medical history, physical examination and clinical judgment of the investigators. - Agree (in the Investigator's opinion) to comply with all study requirements - Agree to allow his or her General Practitioner (and/or Consultant if appropriate), to be notified of participation in the study - Agree to provide their National Insurance/Passport number for the purposes of TOPS registration and bank account information for the purpose of reimbursement for the duration of their participation. Exclusion Criteria: - Have any known or suspected impairment or alteration of immune function, resulting from, for example: - Congenital or acquired immunodeficiency (including IgA deficiency) - Human Immunodeficiency Virus (HIV) infection or symptoms/signs suggestive of an HIV-associated condition - Autoimmune disease - Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy. - Chronic illness that could interfere with immunological function or donation of the required volumes of blood (e.g. cardiac or renal disease, diabetes, or auto-immune disorders). - Receipt of a live vaccine within 4 weeks prior to vaccination or a killed vaccine within 7 days prior to vaccination. - History of group B meningococcal vaccination - Have received a dose of a meningococcal groups A, C, W, Y conjugate vaccine within 30 days of enrolment or wish to receive a dose of this vaccine during the study period. - Plan to receive any vaccine other than the study vaccine within 4 weeks following vaccination. - History of severe allergic reaction after vaccination or known hypersensitivity to any vaccine component - History of meningococcal disease - Receipt of blood, blood products, or plasma derivatives within the past 3 months. - Recent significant blood donation (e.g., to the National Blood Service) within 8 weeks of enrolment, or plans to donate blood during the study period. - Thrombocytopenia or any bleeding disorder. - Pregnancy as confirmed by a positive pregnancy test, or currently breastfeeding. - Enrolled in another study, which, in the opinion of the investigator, could compromise the integrity of either study being conducted. - A member of staff on the delegation log - According to the TOPS database, have recently taken part in a significant number of other studies, which, in the opinion of the investigator, warrant exclusion from further studies. - Have any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Centre for Clinical Vaccinology and Tropical Medicine (CCVTM) | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory immunology to investigate the role of anti-FHBp antibodies in meningococcal immunity | Exploratory assays including Factor H (FH) - FHbp binding inhibition assays, antibody binding to live bacteria measured by flow cytometry, passive transfer experiments using infant rat bacteraemia model. | 3 months | |
Primary | To characterise the breadth of protective activity of serum anti-FHbp antibody responses of adults immunised with 4CMenB (Bexsero) vaccine | As measured by IgG antibody responses to FHbp as measured by serum bactericidal activity against a panel of genetically diverse meningococcal strains | 3 months | |
Secondary | To investigate the nature of the B-cell response that supports the induction of antibody with functional activity following vaccination with 4CMenB | Quantification of circulating vaccine-induced memory B-cells specific for vaccine antigens before and after each, dose. | 3 months | |
Secondary | To investigate the nature of the T-cell response that supports the induction of antibody with functional activity following vaccination with 4CMenB | Quantification of vaccine-induced, antigen specific T-cell responses and associated cytokine production before and after each dose. | 3 months | |
Secondary | Determine whether adults immunised with 4CMenB develop serum IgG and IgM antibodies to human FH | Serum IgG and IgM antibodies to human FH will as measured by ELISA | 3 months |
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