Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013871
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2001-03-31
Brief Title:
Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving 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 the Immunogenicity of Pneumococcal Conjugate Vaccine and Routine Pediatric Immunizations 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 if 2 doses of Pneumococcal Conjugate Vaccine PCV followed by 1 dose of Pneumococcal Polysaccharide Vaccine PPV in HIV-infected children on anti-HIV therapy is helpful and safe in fighting pneumococcal infections in this group of children This study will also look at the protection provided by childhood vaccination against measles pertussis and hepatitis B virus
Pneumococcal infections are the most common AIDS-related infection in HIV-infected children PCV may help reduce the chances of HIV-infected children getting pneumococcal infections This study will look at whether pneumococcal vaccines are safe and effective in HIV-infected children receiving HAART It will look at whether HIV-infected children are protected by childhood vaccines received previously and if more doses are safe and improve protection
Pneumococcal infections are the most common AIDS-related infection in HIV-infected children PCV may help reduce the chances of HIV-infected children getting pneumococcal infections This study will look at whether pneumococcal vaccines are safe and effective in HIV-infected children receiving HAART It will look at whether HIV-infected children are protected by childhood vaccines received previously and if more doses are safe and improve protection
Detailed Description:
Infection by Streptococcus pneumoniae is the most frequent opportunistic infection observed in HIV-infected children PCVs are immunogenic and efficacious in normal children and offer hope of reducing pneumococcal infections in HIV-infected children The degree to which children on HAART are protected by prior immunizations and are responsive to new immunizations is still largely undefined This study is designed to answer whether PCV immunizations are safe and effective The immune responses to prior immunizations and responsiveness to booster doses of vaccines against measles pertussis and hepatitis B virus of children on HAART will also be examined Answers to these questions will determine whether these children are likely to be protected against these clinically relevant pathogens and whether they should routinely receive booster doses of these vaccines after a period of HAART
Patients are stratified on the basis of CD4 percentage and age Patients that previously received a primary hepatitis B vaccine HBV series receive an HBV immunization at entry Other vaccinations may be given based on age andor CD4 cell measurement and immunization status for PCV at entry and 2 months and measles-mumps-rubella MMR vaccine and PPV at 4 months Some patients may be administered DTaP at a 6-month visit on the basis of age previous immunization history and negative tetanus antibody status Follow-up visits are done at 8 12 and 24 months Blood samples are collected at all clinic visits for assessment of HIV RNA immune responses against pneumococcus measles pertussis and hepatitis B virus as well as for laboratory evaluations
Patients are stratified on the basis of CD4 percentage and age Patients that previously received a primary hepatitis B vaccine HBV series receive an HBV immunization at entry Other vaccinations may be given based on age andor CD4 cell measurement and immunization status for PCV at entry and 2 months and measles-mumps-rubella MMR vaccine and PPV at 4 months Some patients may be administered DTaP at a 6-month visit on the basis of age previous immunization history and negative tetanus antibody status Follow-up visits are done at 8 12 and 24 months Blood samples are collected at all clinic visits for assessment of HIV RNA immune responses against pneumococcus measles pertussis and hepatitis B virus as well as for laboratory evaluations
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 |
|---|---|---|---|
| ACTG P1024 | Registry Identifier | DAIDS ES Registry Number | None |
| PACTG 1024 | None | None | None |
| 10609 | REGISTRY | None | None |