HIV/AIDSNCT04239430
Propositive (Protecting Positive People From Meningococcal Infection) Follow-up Study
An observational study of HIV/AIDS and Meningococcal Disease, run by St George's, University of London at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 47 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Meningococcal Disease
- What is being tested?
- Serum Bactericidal Assays
- Type of treatment
- Vaccines
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Nov 2020to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 47 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population is the same as for the original Propositive study. This study will follow up the same cohort of participants.
Who may be able to join
- Received vaccination with Bexsero and Menveo during Propositive study
- Able to sign fully informed consent
- Able to comply with study requirements
Who cannot join
- Unwilling or unable to comply with study requirements
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St George's University of London
London
Catherine Cosgrove, PhD, 02087253887, ccosgrov@sgul.ac.uk
Alberto San Francisco Ramos, LMS
About this study
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
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.
- Conditions
- HIV/AIDS, Meningococcal Disease
- Being tested
- Serum Bactericidal Assays
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Bactericidal AssaysDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (1)
Serum bactericidal Assay responses against relevant MenACWY strains at 18 and 30 months post two doses Menveo (administered concomitantly with Bexsero)
- rSBA GMTs for MenACWY antigens at 18 and 30 months.
- 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.
- The proportion of subjects with "protective" rSBA titres >8 against relevant MenACWY serogroups at 18 and 30 months.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start26 Nov 2020
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health England
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239430
- Sponsor's protocol ID
- 2019.0374
- Status last verified
- Jul 2021
- First submitted
- 20 Jan 2020
- Last updated
- 2 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04239430
- Acronym / sponsor ID
- 2019.0374
- Conditions
- HIV/AIDS, Meningococcal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- Public Health England
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 47 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population is the same as for the original Propositive study. This study will follow up the same cohort of participants.
Key inclusion criteria (3 listed)
- Received vaccination with Bexsero and Menveo during Propositive study
- Able to sign fully informed consent
- Able to comply with study requirements
Key exclusion criteria (1 listed)
- Unwilling or unable to comply with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum Bactericidal AssaysBlood 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. | Diagnostic test | – |
Primary outcome
Serum bacteridical Assay responses against relevant MenB strains at 18 and 30 months post two doses Bexsero (administered concomitantly with Menveo)
Time frame: 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
1. Geometric Mean Titres against relevant MenB strains at 18 and 30 months post two doses of Bexsero 2. 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 3. The proportion of subjects with "protective" hSBA titres >4 against relevant MenB strains at 18 months and 30 months post two doses of Bexsero
1 secondary outcome
Serum bactericidal Assay responses against relevant MenACWY strains at 18 and 30 months post two doses Menveo (administered concomitantly with Bexsero)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS and Meningococcal Disease, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum bacteridical Assay responses against relevant MenB strains at 18 and 30 months post two doses Bexsero (administered concomitantly with Menveo) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.