Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459316
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
2007-04-10
Brief Title:
Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase III Study of Safety and Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine MCV4 in HIV-Infected Children and Youth And Open Label Immunogenicity Study of a Booster Dose of MCV4 in Previously Immunized HIV-Infected Children and Youth
Status:
COMPLETED
Status Verified Date:
2021-10
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:
None
Brief Summary:
Bacterial meningitis infection is common in youth 2 to 24 years of age in the United States This disease can be treated by antibiotics but mortality rates associated with meningitis of up to 53 have been estimated Vaccination against meningitis may be effective in preventing this disease especially for HIV-infected youth who have weakened immune systems The purpose of this study was to determine the safety of and immune response to a preventive meningitis vaccine in HIV-infected youth
Detailed Description:
In the United States youth 2 to 24 years of age are at high risk for bacterial meningitis infection Despite antibiotic treatment the mortality rate for meningitis and sepsis can reach as high as 53 caused by Neisseria meningitidis This rate could be higher in immunocompromised individuals such as those infected with HIV To prevent infection vaccination against meningitis is recommended by the CDC at ages 11 15 and 18 The quadrivalent meningococcal conjugate vaccine MCV4 is a vaccine that has been observed to elicit an appropriate immune response to N meningitidis and was approved by the FDA in January 2005 However to date no studies have been done to determine the safety and immunogenicity of this vaccine in HIV-infected individuals The purpose of this study was to determine the safety and immunogenicity of MCV4 in HIV-infected youth 2 to 24 years of age
The study was originally designed for participants to be followed for 72 weeks Participants were enrolled in three groups by age and CD4 as follows
Group 1 Age 11 to 24 years CD4 of 15 or higher Enrollment was further stratified by CD4 15 to 25 and 25
Group 2 Age 11 to 24 years CD4 15
Group 3 Age 2 to 10 years CD4 of 25 or higher
At study entry all study participants received one injection of MCV4 Step 1 Participants were observed for 30 minutes post-injection to monitor for adverse events A clinic visit was required 24 hours post-injection if the participant reported adverse events At Week 24 participants in Group 1 who did not experience any disqualifying adverse events after the first injection were randomly assigned to receive a second injection of MCV4 or no further injections Group 2 and Group 3 participants who had no disqualifying adverse events after the first injection received a second injection of MCV4 at Week 24 Step 2
There were five study visits in Steps 1 and 2 they occurred at study entry and at Weeks 4 24 28 and 72 At these visits a physical exam assessment of HIV-related symptoms and blood collection occurred In addition study participants were contacted by telephone at Days 3 and 7 and Weeks 1 6 and 25 after the first vaccination Participants in Groups 1B and 2 who received a second injection were contacted by telephone at Weeks 30 and 48
As of November 2010 due to data from this study P1065 and recommendations from the Advisory Committee for Immunization Practices ACIP of the Center for Disease Control CDC eligible participants in Groups 1 1A and 1B and 3 of P1065 received a booster dose of MCV4 at approximately 35 years - 6 months after the initial MCV4 vaccination Participants were then observed for 30 minutes post-injection to monitor for adverse events Participants were also observed at Week 1 for vaccine adverse reactions
This portion of the study Step 3 lasted an additional 24 weeks There were 4 study visits they occurred at entry at Days 7-8 and at Weeks 4 and 24 At these visits a physical exam assessment of HIV-related symptoms and blood collection occurred The purpose of this follow-up study was to determine the safety and immunogenicity of a MCV4 booster dose in HIV-infected participants who have previously received one or two MCV4 vaccinations on this study
The study was originally designed for participants to be followed for 72 weeks Participants were enrolled in three groups by age and CD4 as follows
Group 1 Age 11 to 24 years CD4 of 15 or higher Enrollment was further stratified by CD4 15 to 25 and 25
Group 2 Age 11 to 24 years CD4 15
Group 3 Age 2 to 10 years CD4 of 25 or higher
At study entry all study participants received one injection of MCV4 Step 1 Participants were observed for 30 minutes post-injection to monitor for adverse events A clinic visit was required 24 hours post-injection if the participant reported adverse events At Week 24 participants in Group 1 who did not experience any disqualifying adverse events after the first injection were randomly assigned to receive a second injection of MCV4 or no further injections Group 2 and Group 3 participants who had no disqualifying adverse events after the first injection received a second injection of MCV4 at Week 24 Step 2
There were five study visits in Steps 1 and 2 they occurred at study entry and at Weeks 4 24 28 and 72 At these visits a physical exam assessment of HIV-related symptoms and blood collection occurred In addition study participants were contacted by telephone at Days 3 and 7 and Weeks 1 6 and 25 after the first vaccination Participants in Groups 1B and 2 who received a second injection were contacted by telephone at Weeks 30 and 48
As of November 2010 due to data from this study P1065 and recommendations from the Advisory Committee for Immunization Practices ACIP of the Center for Disease Control CDC eligible participants in Groups 1 1A and 1B and 3 of P1065 received a booster dose of MCV4 at approximately 35 years - 6 months after the initial MCV4 vaccination Participants were then observed for 30 minutes post-injection to monitor for adverse events Participants were also observed at Week 1 for vaccine adverse reactions
This portion of the study Step 3 lasted an additional 24 weeks There were 4 study visits they occurred at entry at Days 7-8 and at Weeks 4 and 24 At these visits a physical exam assessment of HIV-related symptoms and blood collection occurred The purpose of this follow-up study was to determine the safety and immunogenicity of a MCV4 booster dose in HIV-infected participants who have previously received one or two MCV4 vaccinations on this study
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 |
|---|---|---|---|
| PACTG P1065 | Registry Identifier | DAIDS ES Registry Number | None |
| 10396 | REGISTRY | None | None |
| IMPAACT P1065 | None | None | None |