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| Name | Class |
|---|---|
| Public Health England | OTHER_GOV |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum Bactericidal Assays | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum bacteridical Assay responses against relevant MenB strains at 18 and 30 months post two doses Bexsero (administered concomitantly with Menveo) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
• Unwilling or unable to comply with study requirements
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The study population is the same as for the original Propositive study. This study will follow up the same cohort of participants.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St George's University of London | Recruiting | London | United Kingdom |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 5, 2023 | |
| Reset | May 31, 2024 | |
| Release | Jul 10, 2024 | |
| Reset | Oct 11, 2024 | |
| Release | Jun 11, 2025 | |
| Reset | Jun 30, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 5, 2023 | May 31, 2024 | |||
| Jul 10, 2024 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D058248 | Serum Bactericidal Antibody Assay |
| ID | Term |
|---|---|
| D012698 | Serologic Tests |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 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 |
| Oct 11, 2024 |
| Jun 11, 2025 | Jun 30, 2025 |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |