Propositive (Protecting Positive People From Meningococcal Infection) Follow-up Study

HIV/AIDS Clinical Trial

Official title:

Evaluation of the Immunogenicity of Meningococcal B (4CMenB) and Meningococcal ACWY (MenACWY Conjugate) Vaccination in a Population With HIV at 18 and 30 Months After Two Doses of Vaccine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04239430
• Other study ID #: 2019.0374
• Status: Recruiting
• Start date: November 26, 2020
• Est. completion date: April 2022

Study information

• Verified date: July 2021
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The need for and timing of booster doses of meningococcal vaccines in People Living with HIV (PLWHIV) is currently unknown. As such it is impossible for clinicians to recommend booster doses or to know if and when these might be necessary.We propose to follow up a group of participants from the Propositive study who received two doses of both MenB (Bexsero) and MenACWY (Menveo). This was a group of PLWHIV between the ages 18-45 years. We propose following up these participants at 18 and 30 months post completion of two doses of vaccine and investigating their immunological response.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 47 Years

Eligibility

Inclusion Criteria:

• Received vaccination with Bexsero and Menveo during Propositive study
• Able to sign fully informed consent
• Able to comply with study requirements

Exclusion Criteria:

• Unwilling or unable to comply with study requirements

Related Conditions & MeSH terms

• HIV/AIDS
• Meningococcal Disease
• Meningococcal Infections

Intervention

Diagnostic Test:
• Serum Bactericidal Assays
Blood samples will be taken from participants at two time points in the study. Serum Bactericidal Assays from participant serum using relevant MenB and MenACWY strains will be undertaken at 18 and 30 months post two doses of 4CMenB (Bexsero, GSK) and MenACWY-conjugate (Menveo, GSK) vaccine. The Vaccines were given to participants during an earlier clinical trial (Propositive). This trisal is a follow up study.

Locations

Country	Name	City	State
United Kingdom	St George's University of London	London

Sponsors (2)

Lead Sponsor	Collaborator
St George's, University of London	Public Health England

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum bacteridical Assay responses against relevant MenB strains at 18 and 30 months post two doses Bexsero (administered concomitantly with Menveo)	Geometric Mean Titres against relevant MenB strains at 18 and 30 months post two doses of Bexsero; The proportion of subjects with at least 4 fold increase in hSBA against relevant MenB strains from baseline compared to 18 month and 30 months post two doses of Bexsero; The proportion of subjects with "protective" hSBA titres >4 against relevant MenB strains at 18 months and 30 months post two doses of Bexsero	The 18 month blood test is taken 548 days (+/-60 days) from completion of vaccination during the Propositive study and the 30 month blood test is taken 912 days (+/- 60 days) after completion of vaccination
Secondary	Serum bactericidal Assay responses against relevant MenACWY strains at 18 and 30 months post two doses Menveo (administered concomitantly with Bexsero)	4. rSBA GMTs for MenACWY antigens at 18 and 30 months.; 5. The proportion of subjects with at least 4 fold increase in rSBA against relevant MenACWY serogroups from baseline compared to at 18 and 30 months.; 6. The proportion of subjects with "protective" rSBA titres >8 against relevant MenACWY serogroups at 18 and 30 months.	The 18 month blood test is taken 548 days (+/-60 days) from completion of vaccination during the Propositive study and the 30 month blood test is taken 912 days (+/- 60 days) after completion of vaccination