Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000815
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Phase II Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children A Multicenter Trial of the Pediatric AIDS Clinical Trials Group
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children A Multicenter Trial of the Pediatric AIDS Clinical Trials Group
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:
To compare measles seroconversion rates development of antibodies at 13 months of age in HIV-infected and uninfected children on one of two immunization schedules attenuated measlesmumpsrubella virus M-M-R II vaccine at 12 months versus attenuated measles vaccine Attenuvax at 6 months plus M-M-R II vaccine at 12 months
Recommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected childrens humoral immune system
Recommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected childrens humoral immune system
Detailed Description:
Recommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected childrens humoral immune system
Patients HIV infected and uninfected are randomized to one of two attenuated measles vaccine schedules at 6 and 12 months of age or at 12 months of age only Attenuvax is administered as the month 6 vaccine and M-M-R II as the month 12 vaccine Patients are followed for 24 months after the last vaccination
Patients HIV infected and uninfected are randomized to one of two attenuated measles vaccine schedules at 6 and 12 months of age or at 12 months of age only Attenuvax is administered as the month 6 vaccine and M-M-R II as the month 12 vaccine Patients are followed for 24 months after the last vaccination
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 |
|---|---|---|---|
| 11202 | REGISTRY | DAIDS ES Registry Number | None |