Meningococcal B Booster Vaccine in Young People

Not Applicable

Completed

• Conditions: Specialty: Infection, Primary sub-specialty: Vaccines; UKCRC code/ Disease: Inflammatory and Immune System/ Certain disorders involving the immune mechanism; Infections and Infestations; Meningococcal infection, unspecified

• Registration Number: ISRCTN16774163
• Lead Sponsor: niversity of Oxford

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31340842 protocol (added 26/07/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35697571/ (added 15/06/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-10
• Study Completion: 2019-07-01
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

For recruitment to all study groups:
1. Parents/legal guardians are willing and able to comply with the requirements of the trial protocol and have internet access for the duration of the study
2. Parents/legal guardians have given informed consent for their child’s participation in the study
3. Participant is willing and able to give informed assent for participation in the trial
4. In the Investigator’s opinion, participants are able and willing to comply with all trial requirements
5. Parents/legal guardians/participants are willing to allow their General Practitioner and consultant, if appropriate, to be notified of participation in the trial

For recruitment to study groups 1 to 6 only:
Male or female, aged approximately 11 years who have completed a vaccination course of 4CMenB as an infant or toddler in clinical trials V72P6, V72P6E1,V72P9 or V72P9E1

For recruitment to naïve groups 7 and 8 only:
Male or female, born between 25/06/2006 – 17/12/2006 (age range is matched with group 1-6), who have not previously received 4CMenB vaccine. The aim is to recruit approximately 50% female and 50% male participants, in order to match with the previously vaccinated group

Exclusion Criteria

The participant may not enter the trial if ANY of the following apply:
1. Children of parents/legal guardians who are on the delegation log for this study
2. History of invasive meningococcal B disease
3. History of being a household contact with a case of confirmed bacterial meningitis
4. Confirmed or suspected immunodeficiency
5. A family history of congenital or hereditary immunodeficiency, or maternal HIV
6. History of anaphylactic reaction to any component of the vaccine
7. No internet access for the duration of the study
8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
9. Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
10. Prior or planned receipt of any other investigational vaccine or drug
11. Thrombocytopenia or any bleeding disorder
12. Receipt of blood, blood products, or plasma derivatives within the past 3 months

Exclusion to study groups 1 to 6 only:
1. Any previous vaccination with 4CMenB vaccine except as part of V72P6, V72P6E1, V72P9 or V72P9E1 clinical trials
2. Any previous vaccination with another meningococcal B vaccine (such as outer membrane vesicle vaccines)
3. Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 1 month or long-term systemic corticosteroid therapy (e.g. oral prednisolone >0.5ml/kg/day or intravenous glucocorticoid steroid). However, this may be discussed on a case by case basis. Nasal, topical or inhaled steroids are allowed

Exclusion to naïve groups 7 and 8 only:
1. Previous vaccination with 4CMenB vaccine or with any other meningococcal B vaccine (such as outer membrane vesicle vaccines)
2. Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy
3. Current receipt of long-term systemic corticosteroid therapy (e.g. oral prednisolone >0.5ml/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed.
4. Long-term prophylactic antibiotic use

Temporary exclusions for all study groups:
To receiving 4CMenB vaccine:
1. Administration of any other vaccine within 14 days before the study vaccines
2. Scheduled elective surgery, planned admission or other procedures requiring general anaesthesia within 7 days of receiving 4CMen B vaccine
3. Febrile illness (axillary temperature =38°C)
4. Significant acute or chronic infection within the previous 7 days, or fever (=38°C) within the previous 3 days

For blood draw to be performed:
1. Receipt of systemic antibiotics within the previous 7 days
2. For participants in groups 1-6 who are unable to cease long-term antibiotics for one week prior to the scheduled study visit, we will not take blood samples for analysis. The trialists will still vaccinate these part

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum bactericidal assay against N. meningitidis serogroup B indicator strains before and after vaccination

Secondary Outcome Measures

Name	Time	Method
Serum bactericidal assay (SBA) against vaccine strains of MenB will be measured to indicate the antibody response before vaccination at baseline. The differences in SBA will compared between the different treatment groups to indicate if there is any persistence of immunity in the children who have previously had a MenB vaccine.