Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04875819
Status:
RECRUITING
Last Update Posted:
2021-05-06
First Post:
2021-04-12
Brief Title:
Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV
Sponsor:
Thomas Benfield
Organization:
Hvidovre University Hospital
Study Overview
Official Title:
Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV A Single Center Non-blinded Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MENPI
Brief Summary:
MENPI is an investigator-initiated single-centre randomized controlled trial which aims to assess the efficacy and safety of meningococcal and pneumococcal vaccination in adults living with HIV receiving antiretroviral treatment
Participants are randomized 11 to either a two-dose Menveo and Bexsero regimen or a Prevenar13Pneumovax23 prime-boost regimen at day 0 and day 60 and cross over on day 90 All participants will follow an identical follow up program including plasma collection pharyngeal swab and adverse event registration
Immunogenicity will be determined on venous blood sampled at 30 days post-vaccination and yearly for five years
Participants are randomized 11 to either a two-dose Menveo and Bexsero regimen or a Prevenar13Pneumovax23 prime-boost regimen at day 0 and day 60 and cross over on day 90 All participants will follow an identical follow up program including plasma collection pharyngeal swab and adverse event registration
Immunogenicity will be determined on venous blood sampled at 30 days post-vaccination and yearly for five years
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-000863-22 | EUDRACT_NUMBER | None | None |