Ignite Creation Date:
2024-05-06 @ 3:23 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02274415
Status:
COMPLETED
Last Update Posted:
2022-09-09
First Post:
2014-09-22
Brief Title:
Immunogenicity Study of an Anti-pneumococcal Vaccination Strategy in Patients With Sickle Cells Disease
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Study of the Immunogenicity of a Prime Boost Vaccination Strategy Combining Conjugated Anti-pneumococcal and Polysaccharide Anti-pneumococcal Vaccine Compared to Polysaccharide Anti -Pneumococcal Vaccine Alone in Patients With Sickle Cells Disease
Status:
COMPLETED
Status Verified Date:
2017-10
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:
DREVAC
Brief Summary:
Streptococcus pneumoniae is the major cause of bacterial infection in patients with sickle cells disease
The 23-valent pneumococcal polysaccharide vaccine PSV is supposed to be poorly immunogenic in these patients We want to evaluate whether a prime with a 13-valent pneumococcal conjugate vaccine PCV able to induce immunologic memory would improve the immune response against SP polysaccharides SPP
Primary objective To evaluate and compare the specific antibody response to a prime-boost vaccine strategy combining PCV prime at W0 followed by the administration of PSV boost at W4 to the administration of PSV alone at W4 in patients with sickle cells disease
Secondary objectives Evaluation and comparison of the specific antibody response to the thirteen pneumococcal serotypes shared by the PCV and PSV vaccines 4 weeks after the single PSV vaccination for patients from Group 1 or 4 weeks after the boost PSV vaccination for patients from group 2 Evaluation of the duration of the specific antibody response at W24 and 96 Evaluation of the T CD4 lymphocyte response to the CRM 197 protein Safety of the vaccines
Study Design Randomised monocentric controlled phase II study of the immunological efficacy of a prime boost strategy combining the sequential administration of the PCV and PSV compared to the administration of the PSV alone 180 adults patients with sickle cells disease will be included The primary endpoint proportion of responders at W8 to at least 10 of thirteen serotypes Secondary endpoints Proportion of responders at W8 according to 4 categories of responders 5-7 3-4 2-1 and 0 Evaluation of the pneumococcal opsonophagocytic activity OPA at baseline and W8 for each serotype defined as the proportion of patients with OPA 18 geometric mean of the specific antibody titers proportion of patients who experienced an increase of specific antibody levels 1 gml Evaluation of the priming effect of the PCV vaccine in the group 1 Duration of the specific antibody responses at week 24 and W96 CD4 T lymphocyte responses to the CRM 197 protein proliferative and cytokine production at weeks 0 8 and 12 Safety of the vaccines frequency of Streptococcus pneumoniae infections
Statistical Considerations With a sample size of 180 patients and a randomization ration of 11 the study will have a power of at least 90 to show a difference of 25 category between the group receiving PCV and PSV vs the group receiving PSV alone two-sided type I error 5 The primary comparison between both groups will be performed using a Chi2 test for independent groups or a Fisher exact test where appropriate
The 23-valent pneumococcal polysaccharide vaccine PSV is supposed to be poorly immunogenic in these patients We want to evaluate whether a prime with a 13-valent pneumococcal conjugate vaccine PCV able to induce immunologic memory would improve the immune response against SP polysaccharides SPP
Primary objective To evaluate and compare the specific antibody response to a prime-boost vaccine strategy combining PCV prime at W0 followed by the administration of PSV boost at W4 to the administration of PSV alone at W4 in patients with sickle cells disease
Secondary objectives Evaluation and comparison of the specific antibody response to the thirteen pneumococcal serotypes shared by the PCV and PSV vaccines 4 weeks after the single PSV vaccination for patients from Group 1 or 4 weeks after the boost PSV vaccination for patients from group 2 Evaluation of the duration of the specific antibody response at W24 and 96 Evaluation of the T CD4 lymphocyte response to the CRM 197 protein Safety of the vaccines
Study Design Randomised monocentric controlled phase II study of the immunological efficacy of a prime boost strategy combining the sequential administration of the PCV and PSV compared to the administration of the PSV alone 180 adults patients with sickle cells disease will be included The primary endpoint proportion of responders at W8 to at least 10 of thirteen serotypes Secondary endpoints Proportion of responders at W8 according to 4 categories of responders 5-7 3-4 2-1 and 0 Evaluation of the pneumococcal opsonophagocytic activity OPA at baseline and W8 for each serotype defined as the proportion of patients with OPA 18 geometric mean of the specific antibody titers proportion of patients who experienced an increase of specific antibody levels 1 gml Evaluation of the priming effect of the PCV vaccine in the group 1 Duration of the specific antibody responses at week 24 and W96 CD4 T lymphocyte responses to the CRM 197 protein proliferative and cytokine production at weeks 0 8 and 12 Safety of the vaccines frequency of Streptococcus pneumoniae infections
Statistical Considerations With a sample size of 180 patients and a randomization ration of 11 the study will have a power of at least 90 to show a difference of 25 category between the group receiving PCV and PSV vs the group receiving PSV alone two-sided type I error 5 The primary comparison between both groups will be performed using a Chi2 test for independent groups or a Fisher exact test where appropriate
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P100105 | OTHER | Assistance Publique Hôpitaux de Paris | None |