Clinical trial NCT03682939: Evaluation of Safety and Immunogenicity of Meningococcal B and Meningococcal ACWY Vaccine in at Risk Population
Official title: Evaluation of Safety and Immunogenicity of Meningococcal B and Meningococcal ACWY Vaccine in at Risk Population (ProPositive Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hiv
Meningitis, Meningococcal
HIV Infections
Keywords: vaccination
HIV
meningitis
Vaccine
Immunogenicity
Safety
Bexsero
Menveo
co-administration
Lead sponsor: St George's, University of London
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 55
Sex: ALL
Minimum age (years): 10
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: 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
timeFrame: Day 0 (baseline) and Day 60
measure: The proportion of participants who achieve at least a four fold increase in hSBA titres.
timeFrame: Day 60
measure: The proportion of participants who achieve a 'protective' hSBA titre of >1:4 after two doses of Bexsero
timeFrame: Day 60
Secondary outcomes:
measure: 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
timeFrame: Day 7 after vaccines 1 and 2
measure: 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
timeFrame: Day 60
measure: The proportion of subjects with at least a four fold change in rSBA from baseline to 30 days after the second vaccine
timeFrame: Day 0 and Day 60
measure: The proportion of subjects with "protective" rSBA titres >1:8 against relevant MenACWY serogroups after two doses of Menveo
timeFrame: Day 60
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Georges University Hospital
Study officials:
affiliation: St George's, University of London
name: Catherine Cosgrove, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.