Evaluation of Safety and Immunogenicity of Meningococcal B and Meningococcal ACWY Vaccine in at Risk Population (ProPositive)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03682939|
Recruitment Status : Unknown
Verified April 2019 by St George's, University of London.
Recruitment status was: Recruiting
First Posted : September 25, 2018
Last Update Posted : April 10, 2019
- Study Details
- Tabular View
- Results Submitted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Hiv Meningitis, Meningococcal HIV Infections||Biological: Bexsero® (meningitis B vaccine) Biological: Menveo® (meningitis ACWY vaccine)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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:
- 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 [ Time Frame: Day 60 ]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 [ 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||10 Years to 45 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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
|Contact: Catherine Cosgrove, MBBS PhD MRCP||+44(0)firstname.lastname@example.org|
|Contact: Catherine Isitt, MBChB MRCP||+44(0)email@example.com|
|St Georges University Hospital||Recruiting|
|London, United Kingdom, SW17 0RE|
|Contact: Catheirne E Isitt, MBChB 02087252316 firstname.lastname@example.org|
|Principal Investigator:||Catherine Cosgrove, MBBS PhD||St George's, University of London|
|Responsible Party:||St George's, University of London|
|Other Study ID Numbers:||
|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|
|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|
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections and Mycoses
Gram-Negative Bacterial Infections
Central Nervous System Infections
Physiological Effects of Drugs