Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342628
Status:
COMPLETED
Last Update Posted:
2012-06-27
First Post:
2006-06-19
Brief Title:
Safety Immunogenicity and Compatibility With DTP of a Typhoid Fever Vaccine in Infants
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of the Safety Immunogenicity and Compatibility With DTP of an Investigational Vi-rEPA Conjugate Vaccine for Typhoid Fever When Administered to Infants in Vietnam Concurrently With DTP
Status:
COMPLETED
Status Verified Date:
2012-05
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 evaluate the safety immunogenicity and compatibility of our Vi-rEPA conjugate administered to infants with their routine vaccinations
We propose to recruit 300 full term healthy newborns in Vietnam and randomly divide them to receive Vi-rEPA plus DTP Hib-TT not yet used in Vietnam plus DTP or DTP alone Consent is obtained following interviews of mothers during prenatal visits or after delivery All vaccines will be administered at 2 4 and 6 months A booster of Vi-rEPA or Hib-TT conjugate will be administered at 12 months of age and reactions monitored at 6 24 and 48 hours after each injection Maternal and cord blood samples are collected during labor and at delivery Blood will be taken at 7 and 12 months of age from all study infants and at 13 months from infants injected with Vi-rEPA or with Hib-TT at 12 months The blood samples will be assayed for Vi Hib diphtheria tetanus and pertussis antibodies
The levels of serum IgG anti-Vi elicited by Vi-rEPA administered to infants by the above schedule will be compared to those elicited by this vaccine in 2 to 5 year-olds in the efficacy trial conducted in Dong Thap Province Vietnam
We propose to recruit 300 full term healthy newborns in Vietnam and randomly divide them to receive Vi-rEPA plus DTP Hib-TT not yet used in Vietnam plus DTP or DTP alone Consent is obtained following interviews of mothers during prenatal visits or after delivery All vaccines will be administered at 2 4 and 6 months A booster of Vi-rEPA or Hib-TT conjugate will be administered at 12 months of age and reactions monitored at 6 24 and 48 hours after each injection Maternal and cord blood samples are collected during labor and at delivery Blood will be taken at 7 and 12 months of age from all study infants and at 13 months from infants injected with Vi-rEPA or with Hib-TT at 12 months The blood samples will be assayed for Vi Hib diphtheria tetanus and pertussis antibodies
The levels of serum IgG anti-Vi elicited by Vi-rEPA administered to infants by the above schedule will be compared to those elicited by this vaccine in 2 to 5 year-olds in the efficacy trial conducted in Dong Thap Province Vietnam
Detailed Description:
Typhoid fever remains common serious and difficult-to-treat throughout the world including Vietnam Limitations of the three licensed typhoid vaccines have prevented their use for routine vaccination of infants The most recent Vi polysaccharide typhoid vaccine is useful only in individuals greater than or equal to 5 years of age because of its age-related and T-cell independent properties The immunogenicity of Vi in individuals less than 5 years-old has been improved by binding it to a protein In 2 to 4-year-olds 2 injections of the Vi conjugate induced higher levels of serum IgG anti-Vi than Vi in 5 to 14-year-olds
A double-blind placebo controlled and randomized efficacy study in 2 -to-5 years old children in Vietnam showed an over-all efficacy after 27 months of active surveillance followed by 19 months of passive surveillance of 89 Subsequently a dosage study in the same age group showed the highest antibody levels were induced by the 25 mcg dose
Now we wish to evaluate the safety immunogenicity and compatibility of our Vi-rEPA conjugate administered to infants with their routine vaccinations
We propose to recruit 300 full term healthy newborns in Vietnam and randomly divide them to receive Vi-rEPA plus DTP Group A Hib-TT not yet used in Vietnam plus DTP Group B or DTP alone Group C Maternal and cord blood are taken routinely on all deliveries in Vietnam these sera will be retrieved for storage when consent is obtained following interviews of mothers during prenatal visits or after delivery All vaccines will be administered at 2 4 and 6 months A booster of Vi-rEPA or Hib-TT conjugate will be administered at 12 months of age and reactions monitored at 6 24 and 48 hours after each injection Blood will be taken at 7 and 12 months of age from all study infants and at 13 months from infants injected with Vi-rEPA or with Hib-TT at 12 months The blood samples will be assayed for Vi Hib diphtheria tetanus and pertussis antibodies
The levels of serum IgG anti-Vi elicited by Vi-rEPA administered to infants by the above schedule will be compared to those elicited by this vaccine in 2 to 5 year-olds in the efficacy trial conducted in Dong Thap
A double-blind placebo controlled and randomized efficacy study in 2 -to-5 years old children in Vietnam showed an over-all efficacy after 27 months of active surveillance followed by 19 months of passive surveillance of 89 Subsequently a dosage study in the same age group showed the highest antibody levels were induced by the 25 mcg dose
Now we wish to evaluate the safety immunogenicity and compatibility of our Vi-rEPA conjugate administered to infants with their routine vaccinations
We propose to recruit 300 full term healthy newborns in Vietnam and randomly divide them to receive Vi-rEPA plus DTP Group A Hib-TT not yet used in Vietnam plus DTP Group B or DTP alone Group C Maternal and cord blood are taken routinely on all deliveries in Vietnam these sera will be retrieved for storage when consent is obtained following interviews of mothers during prenatal visits or after delivery All vaccines will be administered at 2 4 and 6 months A booster of Vi-rEPA or Hib-TT conjugate will be administered at 12 months of age and reactions monitored at 6 24 and 48 hours after each injection Blood will be taken at 7 and 12 months of age from all study infants and at 13 months from infants injected with Vi-rEPA or with Hib-TT at 12 months The blood samples will be assayed for Vi Hib diphtheria tetanus and pertussis antibodies
The levels of serum IgG anti-Vi elicited by Vi-rEPA administered to infants by the above schedule will be compared to those elicited by this vaccine in 2 to 5 year-olds in the efficacy trial conducted in Dong Thap
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 |
|---|---|---|---|
| OH99-CH-N050 | REGISTRY | NICHD IRB | None |