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Evaluation of Safety and Immunogenicity of Meningococcal B and Meningococcal ACWY Vaccine in at Risk Population (ProPositive)

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ClinicalTrials.gov Identifier: NCT03682939
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
St George's, University of London

Brief Summary:
This study aims to evaluate the immunogenicity, safety and tolerability of co-administration of vaccinations for meningitis B (Bexsero®) and meningitis ACWY (Menveo®) in adults and children aged 10-45 years living with HIV. All participants will be vaccinated with both Menveo® and Bexsero® on days 0 and 30. Immunogenicity will be determined on venous blood sampled at days 0 and 60. Adverse effects will be recorded to evaluate safety.

Condition or disease Intervention/treatment Phase
Hiv Meningitis, Meningococcal HIV Infections Biological: Bexsero® (meningitis B vaccine) Biological: Menveo® (meningitis ACWY vaccine) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Safety and Immunogenicity of Meningococcal B and Meningococcal ACWY Vaccine in at Risk Population (ProPositive Study)
Actual Study Start Date : February 21, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Experimental: Single arm
Single arm, open-label, all participants will receive both Bexsero® (meningitis B vaccine) and Menveo® (meningitis ACWY vaccine) vaccines.
Biological: Bexsero® (meningitis B vaccine)
Bexsero® 0.5ml IM vaccine administered into non-dominant arm of participant

Biological: Menveo® (meningitis ACWY vaccine)
Menveo® 0.5ml IM vaccine administered into dominant arm of participant




Primary Outcome Measures :
  1. Change in hSBA geometric mean titres to relevant strains of meningococcal B following two doses of the 4CmenB vaccine (Bexsero®) in people living with HIV [ Time Frame: Day 0 (baseline) and Day 60 ]
    The human complement serum bactericidal assay (hSBA) mean titres against relevant strains of meningococcal B at baseline and one month after completion of vaccination.

  2. The proportion of participants who achieve at least a four fold increase in hSBA titres. [ Time Frame: Day 60 ]
    Blood will be taken one month after the second vaccine and serum tested for hSBA titres. The proportion of participants who achieve at least a four fold increase in hSBA titres will be calculated.

  3. The proportion of participants who achieve a 'protective' hSBA titre of >1:4 after two doses of Bexsero [ Time Frame: Day 60 ]
    Blood will be taken one month after the second vaccine and serum tested for hSBA titres. The proportion of participants who are deemed to have protective titres >1:4 will be calculated.


Secondary Outcome Measures :
  1. The incidence of solicited and unsolicited adverse and serious adverse events after two doses of MenACWY (Menveo®) and 4CMenB (Bexsero®) vaccines when co-administered in people living with HIV [ Time Frame: Day 7 after vaccines 1 and 2 ]

    We will assess the following:

    1. The incidence of subjects with solicited local and systemic AEs up to 7 days (including the day of vaccination) after Visits 1 and 2.
    2. The incidence of subjects with any other (unsolicited) AEs, including any SAEs, AEs leading to withdrawal and medically attended AEs up to 7 days (including the day of vaccination) after Visits 1 and 2.
    3. The incidence of subjects with SAEs and AEs leading to withdrawal throughout the study period.

  2. The geometric mean titres to Meningococcal ACWY antigens after two doses of the MenACWY (Menveo®) vaccine in people with HIV at one month after the second vaccination [ Time Frame: Day 60 ]
    We will measure rSBA GMTs for MenACWY antigens at baseline and Visit3.

  3. The proportion of subjects with at least a four fold change in rSBA from baseline to 30 days after the second vaccine [ Time Frame: Day 0 and Day 60 ]
    The proportion of subjects with at least 4 fold increase in rSBA against relevant MenACWY serogroups from baseline to Visit3.

  4. The proportion of subjects with "protective" rSBA titres >1:8 against relevant MenACWY serogroups after two doses of Menveo [ Time Frame: Day 60 ]
    The proportion of subjects with "protective" rSBA titres >1:8 against relevant MenACWY serogroups at Visit3.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any 10-45-year old male or female patients with confirmed HIV infection where they (or someone with parental responsibility) can sign fully informed consent and are able to comply with study requirements.

Exclusion Criteria:

  • Pregnancy or breast feeding,
  • History of MenACWY (Menveo® or Nimenrix®) and 4CMenB (Bexsero®) vaccination in the previous 2 years,
  • Receipt of other non-live vaccines within 2 weeks and live vaccines within 4 weeks of first dose, planned receipt of vaccine within 2 weeks of study visits,
  • Current active malignancy,
  • Known latex allergy
  • Known or suspected hypersensitivity to any components of the vaccines or history of severe allergic reaction after previous vaccination
  • Bleeding disorder preventing IM vaccination,
  • Any acute or chronic illness which according to the investigators judgement would prevent patients to receive the vaccines or participate in the study
  • Participation in clinical trials concerning investigational medical product within 0 days or before completion of the study
  • Children in care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682939


Contacts
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Contact: Catherine Cosgrove, MBBS PhD MRCP +44(0)2087252316 ccosgrov@sgul.ac.uk
Contact: Catherine Isitt, MBChB MRCP +44(0)2087252316 cisitt@sgul.ac.uk

Locations
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United Kingdom
St Georges University Hospital Recruiting
London, United Kingdom, SW17 0RE
Contact: Catheirne E Isitt, MBChB    02087252316    vaccine@sgul.ac.uk   
Sponsors and Collaborators
St George's, University of London
Investigators
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Principal Investigator: Catherine Cosgrove, MBBS PhD St George's, University of London

Publications:

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Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT03682939     History of Changes
Other Study ID Numbers: 17.0177
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by St George's, University of London:
vaccination
HIV
meningitis
Vaccine
Immunogenicity
Safety
Bexsero
Menveo
co-administration
Additional relevant MeSH terms:
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Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs