Safety, Tolerability and Immunogenicity of 4CMenB Vaccine(2 Doses) in Adults With an Immunodeficiency (4CMenB)

January 18, 2024 updated by: Laura Sticchi, Ospedale Policlinico San Martino

Evaluation of Safety, Tolerability and Immunogenicity of Two Doses of the 4CMenB Vaccine in Adults With an Immunodeficiency

The meningococcal quadrivalent conjugate vaccine (MenACWY) and the licenced multicomponent MenB vaccine (Bexsero®) have already been included in the Italian childhood immunization programme and recommendations for high risk categories have been also implemented.

As by NIP, vaccination against MenB with either 4CMenB or fHbp-MenB is offered for free for several conditions including subjects with severe primary or secondary immunodeficiency.

In Liguria Region meningococcal vaccination is actively offered to several chronic conditions including asplenia, patients with lymphoproliferative disease (also HSCT), subject treated with anti-CD20 mAb and HIV-positive.

In Liguria Region there is a large diverse population with risk condition that, as by national and regional recommendation, receive meningococcal vaccination. For some of them, i.e. asplenic and complement deficiencies groups, evidence have been generated through an ad hoc clinical trial, while for other important groups there is clear need of immunogenicity data.

In the proposed study, the Investigators plan to administer two doses of MenB vaccine (Bexsero®), 1-2 months apart, to adult patients living in Genoa area and belonging to following categories:

  • Bone marrow transplant (HSCT patient)
  • HIV positive
  • Alfa-CD20 subjects (i.e. Patients candidates for / in treatment with biologic drugs such as Rituximab).

Immunogenicity data will be then obtained from sera collected at the day of the first Bexsero dose and one month after the immunization course by Serum Bactericidal Activity (SBA) assay.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genoa, Italy, 16132
        • U.O.Igiene Ospedale Policlinico San Martino - IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects aged 18 to 65 years with an acquired immune deficiency, including three study groups:

  • Cohort l-Hematopoietic Stem Celi Transplant (HSCT) patients
  • Cohort 2-HIV infected subjects
  • Cohort 3-patients candidates for / in treatment with biological drugs such as monoclonal antibodies anti CD-20 (rituximab or ocrelizumab)

Description

Inclusion Criteria:

  • Males and females 18 through 65 years of age at the time of enrollment who are high risk for IMD, including subjects with documented medical history of any of the following criteria:

    1. Hematopoietic Stem Celi Transplantation (allogenic or autologous stem celi transplant)
    2. HIV infection
    3. candidate for / in treatment (ongoing) with biological drugs such as monoclonal antibodies anti CD- 20 (rituximab or ocrelizumab)
  • Written informed consent obtained from the subject (or legal representative).
  • Subjects (or legal representative) who are able to comprehend all procedures and to comply with the study requirements

Exclusion Criteria:

  • Subjects not able to understand and to adhere to ali study procedures
  • Subjects aged <18 or >65 years
  • Known or suspected allergy/hypersensitivity to any vaccine component
  • History of serious adverse reaction to any vaccine
  • Administration of immunoglobulins and/or any blood products within 3 months prior to enrollment or planned administration during the entire study period
  • History of any meningococcal group B vaccination or having been diagnosed with meningococcal disease ever before
  • Stem celi transplantation within 6 months before the enrollment to the study
  • HIV-infected patients with detectable viral load (>50 copies/mL) and/or CD4 celi count < 200 cells/mm3 in the last 6 months
  • Receipt of any vaccine within 28 (for live vaccines) or 14 (for no-live vaccines) days prior to study vaccination
  • Planned vaccination (other than the study vaccination) during the entire study period
  • Fever or any acute disease or infection within 3 days prior to vaccination
  • Receipt of any antibiotics within 3 days before enrollment
  • Coagulation disorder contraindicating intramuscular vaccination Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with the study procedures
  • Current participation to another investigational study or planned enrollment to an investigational during the entire study period
  • Planned surgery or hospitalization during the entire study period
  • Subjects who participated in Cohort 1, 2 or 3, cannot be included in other different cohorts
  • Pregnancy or breastfeeding (asking the woman to sign a declaration that she is not pregnant or breastfeeding).
  • Any contraindication to the study vaccine (Bexsero®) as specified in the Summary of Product Characteristics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Hematopoietic Stem Celi Transplant (HSCT) patients
Biological: 4CMenB (Bexsero®) vaccine
Participants will receive 2 doses of 4CMenB (Bexsero®) vaccine administered intramuscularly 1-2 months apart
Cohort 2
HIV infected subjects
Biological: 4CMenB (Bexsero®) vaccine
Participants will receive 2 doses of 4CMenB (Bexsero®) vaccine administered intramuscularly 1-2 months apart
Cohort 3
Patients candidates for / in treatment with biological drugs such as monoclonal antibodies anti CD-20 (rituximab or ocrelizumab)
Biological: 4CMenB (Bexsero®) vaccine
Participants will receive 2 doses of 4CMenB (Bexsero®) vaccine administered intramuscularly 1-2 months apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hSBA geometries mean titres (GMTs) against relevant MenB strains
Time Frame: baseline (Visit 1) and one month after the second vaccination (Visit3).
hSBA geometries mean titres (GMTs) against relevant MenB strains
baseline (Visit 1) and one month after the second vaccination (Visit3).
4 fold increase in hSBA against relevant MenB
Time Frame: Baseline to one month after the second vaccination (Visit3)
The proportion of subjects with at least 4 fold increase in hSBA against relevant MenB strains from baseline to one month after the second vaccination (Visit3)
Baseline to one month after the second vaccination (Visit3)
hSBA titres >1:4 against relevant MenB strains at Visit3 (one month after the second vaccination)
Time Frame: One month after the second vaccination (Visit3)
The proportion of subjects with "protective" hSBA titres >1:4 against relevant MenB strains at Visit3 (one month after the second vaccination).
One month after the second vaccination (Visit3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local and systemic AEs
Time Frame: 7 days (including the day of vaccination) after Visits 1 and 2.
The incidence of subjects with solicited local and systemic AEs (Pain, Erythema, Swelling, Induration, Fever -body temperature ~38.0°C-, Nausea, Myalgia, Arthralgia, Headache, Fatigue) up to 7 days (including the day of vaccination) after Visits 1 and 2.
7 days (including the day of vaccination) after Visits 1 and 2.
Unsolicited AEs
Time Frame: 7 days (including the day of vaccination) after Visits 1 and 2.
The incidence of subjects with any other unsolicited AEs up to 7 days (including the day of vaccination) after Visits 1 and 2.
7 days (including the day of vaccination) after Visits 1 and 2.
SAEs and AEs leading to withdrawal and medically attended visits throughout the study period
Time Frame: An average of 15 months (from the day of first vaccination to the end of the study)
The incidence of subjects with SAEs and AEs leading to withdrawal and medically attended visits throughout the study period
An average of 15 months (from the day of first vaccination to the end of the study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Policlinico San Martino

Collaborators

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2020

Primary Completion (Actual)

January 11, 2024

Study Completion (Actual)

January 11, 2024

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (Actual)

March 4, 2020

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4CMenB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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