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

St George's, University of London

Status and phase: Unknown; Phase 4

Conditions: HIV Infections; Hiv; Meningitis, Meningococcal

Treatments: Biological: Bexsero® (meningitis B vaccine); Biological: Menveo® (meningitis ACWY vaccine)

Study type: Interventional

Funder types: Other

Identifiers

NCT03682939

17.0177

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 10 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Single arm

Experimental group

Description:

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

Treatment:

Biological: Menveo® (meningitis ACWY vaccine)

Biological: Bexsero® (meningitis B vaccine)