Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257127
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2005-11-18
Brief Title:
Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of Immunologic Memory Following Pneumococcal Hepatitis B and Measles Vaccination in HIV Infected Children Treated With Highly Active Antiretroviral Therapy HAART
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:
The purpose of this study is to determine immune system function following vaccination in HIV-infected children currently taking anti-HIV drugs To test the effectiveness of prior vaccination patients in this study will receive booster shots of one of two pneumococcal vaccines a hepatitis B vaccine and a measles vaccine
Detailed Description:
With their immunocompromised status HIV-infected children are at especially high risk for opportunistic infections including infection by Streptococcus pneumoniae hepatitis B and measles In PACTG P1024 HIV-infected children taking highly active antiretroviral therapy HAART received 2 doses of the pneumococcal conjugate vaccine PCV 1 dose of the pneumococcal polysaccharide vaccine PPV and booster shots of the hepatitis B vaccine HBV and measles mumps and rubella vaccine MMR Early responses to these vaccinations were favorable but with declining antibody responses within the 18 months after vaccination It is unknown if additional booster vaccinations in these children will result in a protective immunologic memory upon re-exposure to these pathogens This study will determine whether HIV-infected children on HAART have evidence of specific immunologic memory 3 to 4 years after vaccination in PACTG P1024
Patients will be randomly assigned to receive PCV or PPV at study entry All eligible patients will also receive HBV and MMR at study entry Patients will be monitored in the clinic for 1 hour after vaccination for any adverse effects Study staff will contact patients by phone around Day 3 after study entry to ask patients if they have experienced any adverse effects to the vaccinations patients who received MMR at study entry will be contacted again around Day 21 Some patients may be asked to return to the clinic for further evaluation if they experience side effects
There will be study visits at study entry and Days 7 and 28 Medical history a physical exam blood collection and an assessment of HIV-related symptoms will occur at all visits HAART will not be provided by this study
Patients will be randomly assigned to receive PCV or PPV at study entry All eligible patients will also receive HBV and MMR at study entry Patients will be monitored in the clinic for 1 hour after vaccination for any adverse effects Study staff will contact patients by phone around Day 3 after study entry to ask patients if they have experienced any adverse effects to the vaccinations patients who received MMR at study entry will be contacted again around Day 21 Some patients may be asked to return to the clinic for further evaluation if they experience side effects
There will be study visits at study entry and Days 7 and 28 Medical history a physical exam blood collection and an assessment of HIV-related symptoms will occur at all visits HAART will not be provided by 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 |
|---|---|---|---|
| 10132 | REGISTRY | None | None |
| PACTG P1061s | Registry Identifier | DAIDS ES Registry Number | None |