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

Primary Purpose

Hiv, Meningitis, Meningococcal, HIV Infections

Status

Unknown status

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Bexsero® (meningitis B vaccine)

Menveo® (meningitis ACWY vaccine)

About this trial

This is an interventional other trial for Hiv focused on measuring vaccination, HIV, meningitis, Vaccine, Immunogenicity, Safety, Bexsero, Menveo, co-administration

Eligibility Criteria

10 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St Georges University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Single arm, open-label, all participants will receive both Bexsero® (meningitis B vaccine) and Menveo® (meningitis ACWY vaccine) vaccines.

Outcomes

Primary Outcome Measures

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

The human complement serum bactericidal assay (hSBA) mean titres against relevant strains of meningococcal B at baseline and one month after completion of vaccination.

The proportion of participants who achieve at least a four fold increase in hSBA titres.

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.

The proportion of participants who achieve a 'protective' hSBA titre of >1:4 after two doses of Bexsero

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

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

We will assess the following: The incidence of subjects with solicited local and systemic AEs up to 7 days (including the day of vaccination) after Visits 1 and 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. The incidence of subjects with SAEs and AEs leading to withdrawal throughout the study period.

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

We will measure rSBA GMTs for MenACWY antigens at baseline and Visit3.

The proportion of subjects with at least a four fold change in rSBA from baseline to 30 days after the second vaccine

The proportion of subjects with at least 4 fold increase in rSBA against relevant MenACWY serogroups from baseline to Visit3.

The proportion of subjects with "protective" rSBA titres >1:8 against relevant MenACWY serogroups after two doses of Menveo

The proportion of subjects with "protective" rSBA titres >1:8 against relevant MenACWY serogroups at Visit3.

Full Information

NCT ID

NCT03682939

First Posted

September 13, 2018

Last Updated

April 8, 2019

Sponsor

St George's, University of London

1. Study Identification

Unique Protocol Identification Number

NCT03682939

Brief Title

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

Acronym

ProPositive

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 21, 2019 (Actual)

Primary Completion Date

June 2020 (Anticipated)

Study Completion Date

March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St George's, University of London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hiv, Meningitis, Meningococcal, HIV Infections

Keywords

vaccination, HIV, meningitis, Vaccine, Immunogenicity, Safety, Bexsero, Menveo, co-administration

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single arm

Arm Type

Experimental

Arm Description

Single arm, open-label, all participants will receive both Bexsero® (meningitis B vaccine) and Menveo® (meningitis ACWY vaccine) vaccines.

Intervention Type

Biological

Intervention Name(s)

Bexsero® (meningitis B vaccine)

Intervention Description

Bexsero® 0.5ml IM vaccine administered into non-dominant arm of participant

Intervention Type

Biological

Intervention Name(s)

Menveo® (meningitis ACWY vaccine)

Intervention Description

Menveo® 0.5ml IM vaccine administered into dominant arm of participant

Primary Outcome Measure Information:

Title

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

Description

The human complement serum bactericidal assay (hSBA) mean titres against relevant strains of meningococcal B at baseline and one month after completion of vaccination.

Time Frame

Day 0 (baseline) and Day 60

Title

The proportion of participants who achieve at least a four fold increase in hSBA titres.

Description

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.

Time Frame

Day 60

Title

The proportion of participants who achieve a 'protective' hSBA titre of >1:4 after two doses of Bexsero

Description

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.

Time Frame

Day 60

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Day 7 after vaccines 1 and 2

Title

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

Description

We will measure rSBA GMTs for MenACWY antigens at baseline and Visit3.

Time Frame

Day 60

Title

The proportion of subjects with at least a four fold change in rSBA from baseline to 30 days after the second vaccine

Description

The proportion of subjects with at least 4 fold increase in rSBA against relevant MenACWY serogroups from baseline to Visit3.

Time Frame

Day 0 and Day 60

Title

The proportion of subjects with "protective" rSBA titres >1:8 against relevant MenACWY serogroups after two doses of Menveo

Description

The proportion of subjects with "protective" rSBA titres >1:8 against relevant MenACWY serogroups at Visit3.

Time Frame

Day 60

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Catherine Cosgrove, MBBS PhD MRCP

Phone

+44(0)2087252316

ccosgrov@sgul.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Catherine Isitt, MBChB MRCP

Phone

+44(0)2087252316

cisitt@sgul.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Catherine Cosgrove, MBBS PhD

Organizational Affiliation

St George's, University of London

Official's Role

Principal Investigator

Facility Information:

Facility Name

St Georges University Hospital

City

London

ZIP/Postal Code

SW17 0RE

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Catheirne E Isitt, MBChB

Phone

02087252316

vaccine@sgul.ac.uk

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26654248

Citation

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Results Reference

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25637287

Citation

Dwilow R, Fanella S. Invasive meningococcal disease in the 21st century-an update for the clinician. Curr Neurol Neurosci Rep. 2015 Mar;15(3):2. doi: 10.1007/s11910-015-0524-6.

Results Reference

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PubMed Identifier

24166695

Citation

Miller L, Arakaki L, Ramautar A, Bodach S, Braunstein SL, Kennedy J, Steiner-Sichel L, Ngai S, Shepard C, Weiss D. Elevated risk for invasive meningococcal disease among persons with HIV. Ann Intern Med. 2014 Jan 7;160(1):30-7. doi: 10.7326/0003-4819-160-1-201401070-00731.

Results Reference

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PubMed Identifier

20559040

Citation

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PubMed Identifier

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Citation

Cohn AC, MacNeil JR, Clark TA, Ortega-Sanchez IR, Briere EZ, Meissner HC, Baker CJ, Messonnier NE; Centers for Disease Control and Prevention (CDC). Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2013 Mar 22;62(RR-2):1-28.

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PubMed Identifier

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Citation

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Citation

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

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