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

NCT03682939 | Unknown Phase 4

• 1 other identifier: 17.0177
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv; Meningitis, Meningococcal; HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Day 0 (baseline) and Day 60

• 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.

  Day 60

• 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.

  Day 60

Secondary Outcomes (4)

• 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

  Day 7 after vaccines 1 and 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

  Day 60

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

  Day 0 and Day 60

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

  Day 60

Study Arms (1)

Single arm

EXPERIMENTAL

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

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

Interventions

Bexsero® (meningitis B vaccine) BIOLOGICAL

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

Single arm

Menveo® (meningitis ACWY vaccine) BIOLOGICAL

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

Single arm

Eligibility Criteria

• Age: 10 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

St Georges University Hospital

London, SW17 0RE, United Kingdom

RECRUITING

Related Publications (10)

• Simmons RD, Kirwan P, Beebeejaun K, Riordan A, Borrow R, Ramsay ME, Delpech V, Lattimore S, Ladhani S. Risk of invasive meningococcal disease in children and adults with HIV in England: a population-based cohort study. BMC Med. 2015 Dec 9;13:297. doi: 10.1186/s12916-015-0538-6.

  PMID: 26654248 BACKGROUND

• 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.

  PMID: 25637287 BACKGROUND

• 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.

  PMID: 24166695 BACKGROUND

• Cohen C, Singh E, Wu HM, Martin S, de Gouveia L, Klugman KP, Meiring S, Govender N, von Gottberg A; Group for Enteric, Respiratory and Meningeal disease Surveillance in South Africa (GERMS-SA). Increased incidence of meningococcal disease in HIV-infected individuals associated with higher case-fatality ratios in South Africa. AIDS. 2010 Jun 1;24(9):1351-60. doi: 10.1097/QAD.0b013e32833a2520.

  PMID: 20559040 BACKGROUND

• 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.

  PMID: 23515099 BACKGROUND

• Frota AC, Milagres LG, Harrison LH, Ferreira B, Menna Barreto D, Pereira GS, Cruz AC, Pereira-Manfro W, de Oliveira RH, Abreu TF, Hofer CB. Immunogenicity and safety of meningococcal C conjugate vaccine in children and adolescents infected and uninfected with HIV in Rio de Janeiro, Brazil. Pediatr Infect Dis J. 2015 May;34(5):e113-8. doi: 10.1097/INF.0000000000000630.

  PMID: 25876102 BACKGROUND

• Lujan-Zilbermann J, Warshaw MG, Williams PL, Spector SA, Decker MD, Abzug MJ, Heckman B, Manzella A, Kabat B, Jean-Philippe P, Nachman S, Siberry GK; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1065 Protocol Team. Immunogenicity and safety of 1 vs 2 doses of quadrivalent meningococcal conjugate vaccine in youth infected with human immunodeficiency virus. J Pediatr. 2012 Oct;161(4):676-81.e2. doi: 10.1016/j.jpeds.2012.04.005. Epub 2012 May 22.

  PMID: 22622049 BACKGROUND

• Findlow J, Bai X, Findlow H, Newton E, Kaczmarski E, Miller E, Borrow R. Safety and immunogenicity of a four-component meningococcal group B vaccine (4CMenB) and a quadrivalent meningococcal group ACWY conjugate vaccine administered concomitantly in healthy laboratory workers. Vaccine. 2015 Jun 26;33(29):3322-30. doi: 10.1016/j.vaccine.2015.05.027. Epub 2015 May 27.

  PMID: 26025807 BACKGROUND

• Santolaya ME, O'Ryan ML, Valenzuela MT, Prado V, Vergara R, Munoz A, Toneatto D, Grana G, Wang H, Clemens R, Dull PM; V72P10 Meningococcal B Adolescent Vaccine Study group. Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study. Lancet. 2012 Feb 18;379(9816):617-24. doi: 10.1016/S0140-6736(11)61713-3. Epub 2012 Jan 18.

  PMID: 22260988 BACKGROUND

• Isitt C, Bartolf A, Andrews N, Athaide S, Pryce-Williams R, Townsend-Payne K, Borrow R, Ladhani S, Heath PT, Cosgrove CA. The propositive study: Immunogenicity and safety of a four-component recombinant protein-based vaccine against MenB and a quadrivalent conjugate MenACWY vaccine in people living with HIV. HIV Med. 2023 Sep;24(9):979-989. doi: 10.1111/hiv.13495. Epub 2023 Apr 23.

  PMID: 37088964 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Meningitis, Meningococcal; HIV Infections; Meningitis

Interventions

4CMenB vaccine; Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Catherine Cosgrove, MBBS PhD

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Cosgrove, MBBS PhD MRCP

CONTACT

+44(0)2087252316; ccosgrov@sgul.ac.uk

Catherine Isitt, MBChB MRCP

CONTACT

+44(0)2087252316; cisitt@sgul.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 25, 2018
• Study Start: February 21, 2019
• Primary Completion: June 1, 2020
• Study Completion: March 1, 2021
• Last Updated: April 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)