Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139113
Status:
COMPLETED
Last Update Posted:
2012-08-30
First Post:
2005-08-29
Brief Title:
Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children
Status:
COMPLETED
Status Verified Date:
2024-08
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:
Infants born to immune mothers and therefore having passively-transferred maternal antibody PMA to hepatitis A virus HAV have a blunted immune response to hepatitis A vaccine We compared the immunogenicity of hepatitis A vaccine among infants with and without PMA vaccinated on different schedules We found that when vaccination is begun at or after 12 months of age there was no difference in the immune response to the vaccine between infants born to immune vs susceptible mothers
Detailed Description:
Background Infants with passively-transferred maternal antibody PMA to hepatitis A virus HAV have a blunted immune response to hepatitis A vaccine We compared the immunogenicity of hepatitis A vaccine among infants with and without PMA vaccinated on different schedules
Methods Infants were randomized to one of three groups each receiving two doses of 720 ELU of hepatitis A vaccine HAVRIX Glaxo SmithKline according to the following schedules Group 1 at ages 6 and 12 months Group 2 at ages 12 and 18 months Group 3 at ages 15 and 21 months We determined antibody to HAV anti-HAV status of mothers at the time of delivery and measured infants anti-HAV concentrations at the time of the first vaccine dose baseline and at 1 7 and 12 months thereafter Anti-HAV concentrations 33 milli-International Unitsmilliliter mIUmL were considered protective We monitored adverse reactions using diary cards and chart reviews
Results A total of 239 infants were enrolled including 134 born to anti-HAV negative mothers Groups 1N 2N 3N and 105 born to anti-HAV positive mothers Groups 1P 2P 3P
At month 12 6 months after the second vaccine dose the difference in GMC between Groups 1P and 1N was the only statistically significant difference within groups p005 There were no statistically significant differences in GMC among groups of infants born to anti-HAV negative mothers N groups but the difference between Group 1P and Group 3P infants was significant p 005 No serious adverse reactions related to vaccination were detected
Conclusions Hepatitis A vaccine is immunogenic among infants born to anti-HAV negative mothers and among those born to anti-HAV positive mothers and vaccinated beginning as young as 12 months old The persistence of PMA for at least six months among the majority of infants born to anti-HAV positive mothers results in lower seroconversion rates and GMCs
Methods Infants were randomized to one of three groups each receiving two doses of 720 ELU of hepatitis A vaccine HAVRIX Glaxo SmithKline according to the following schedules Group 1 at ages 6 and 12 months Group 2 at ages 12 and 18 months Group 3 at ages 15 and 21 months We determined antibody to HAV anti-HAV status of mothers at the time of delivery and measured infants anti-HAV concentrations at the time of the first vaccine dose baseline and at 1 7 and 12 months thereafter Anti-HAV concentrations 33 milli-International Unitsmilliliter mIUmL were considered protective We monitored adverse reactions using diary cards and chart reviews
Results A total of 239 infants were enrolled including 134 born to anti-HAV negative mothers Groups 1N 2N 3N and 105 born to anti-HAV positive mothers Groups 1P 2P 3P
At month 12 6 months after the second vaccine dose the difference in GMC between Groups 1P and 1N was the only statistically significant difference within groups p005 There were no statistically significant differences in GMC among groups of infants born to anti-HAV negative mothers N groups but the difference between Group 1P and Group 3P infants was significant p 005 No serious adverse reactions related to vaccination were detected
Conclusions Hepatitis A vaccine is immunogenic among infants born to anti-HAV negative mothers and among those born to anti-HAV positive mothers and vaccinated beginning as young as 12 months old The persistence of PMA for at least six months among the majority of infants born to anti-HAV positive mothers results in lower seroconversion rates and GMCs
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 |