Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00141999
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2005-09-01
Brief Title:
Response to Booster Doses of Hepatitis B Vaccine in Children and Adolescents
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
An Evaluation of Long-Term Protection Against Hepatitis B Virus Infection Response of Alaska Native Children and Adolescents Who Received the Primary Recombinant Hepatitis B Vaccine Series Beginning at Birth to an Additional Dose of Vaccine
Status:
COMPLETED
Status Verified Date:
2012-09
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 the immune response to an additional booster dose of hepatitis B vaccine 5-14 years after a three dose series was given
Detailed Description:
Routine hepatitis B vaccination beginning at birth was provided to Alaska Natives several years before other areas of the United States began routine infant hepatitis B vaccination programs Follow up studies of hepatitis B immunity among Alaska Native children provide an early opportunity to assess long term protection against hepatitis B virus HBV infection for children vaccinated at birth with the currently used recombinant vaccine This protocol describes an evaluation of long-term protection against HBV infection among children who received the recombinant hepatitis B vaccine beginning at birth and who currently receive medical care at the Alaska Native Medical Center ANMC in Anchorage Alaska
The specific objective of this study is to evaluate the immune response to a five microgram dose of recombinant hepatitis B vaccine among 5-6 year old and 10-14 year old children who received the primary recombinant hepatitis B vaccine series beginning at birth The concentration of antibodies to hepatitis B surface antigen anti-HBs will be measured immediately before administering the vaccine and compared with levels in serum drawn 1 2 and 4 weeks afterwards A rapid antibody response anamnestic response indicates that immune memory and therefore immunity to HBV infection is preserved The frequency and magnitude of the anamnestic response for the group of older children will be compared to that of the younger group
Currently there is no recommendation for a routine booster dose of vaccine after receiving three doses at birth This study will provide valuable information regarding the need for and response to an additional dose booster dose of hepatitis B vaccine among children entering primary school or adolescence If evidence of waning immune memory as measured by a delayed or diminished response to the additional dose of vaccine is found these two age groups would be the most easily accessible for routine delivery of a booster dose
The specific objective of this study is to evaluate the immune response to a five microgram dose of recombinant hepatitis B vaccine among 5-6 year old and 10-14 year old children who received the primary recombinant hepatitis B vaccine series beginning at birth The concentration of antibodies to hepatitis B surface antigen anti-HBs will be measured immediately before administering the vaccine and compared with levels in serum drawn 1 2 and 4 weeks afterwards A rapid antibody response anamnestic response indicates that immune memory and therefore immunity to HBV infection is preserved The frequency and magnitude of the anamnestic response for the group of older children will be compared to that of the younger group
Currently there is no recommendation for a routine booster dose of vaccine after receiving three doses at birth This study will provide valuable information regarding the need for and response to an additional dose booster dose of hepatitis B vaccine among children entering primary school or adolescence If evidence of waning immune memory as measured by a delayed or diminished response to the additional dose of vaccine is found these two age groups would be the most easily accessible for routine delivery of a booster dose
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 |
|---|---|---|---|
| U50CCU022279 | None | None | None |