Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368316
Status:
COMPLETED
Last Update Posted:
2012-06-22
First Post:
2006-08-22
Brief Title:
Safety Immunogenicity and Efficacy of Shigella Conjugate Vaccines in 1-4 Year Olds in Israel
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:
Phase 3 Study Safety Immunogenicity and Efficacy of Improved Shigella Conjugate Vaccines in 1-4 Year Olds in Israel
Status:
COMPLETED
Status Verified Date:
2012-06
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:
Shigellosis remains a serious and frequent disease throughout the world Development of vaccines has been difficult because shigellae are habitants of and pathogens for humans only and there is no consensus about the mechanisms of immunity to this pathogen
Incomplete but compelling evidence indicates that a critical level of serum IgG anti-LPS confers immunity to shigellosis Important data come from our clinical trial in the Israel Defense Forces IDF recruits A randomized double-blind vaccine-controlled study showed that the S sonnei-rEPA elicited 74 protection against shigellosis occurring about 3 months after vaccination p0001 This vaccine conferred 43 p004 protection in one company during an outbreak up to 14 days following vaccination suggesting that our Shigella conjugates might be of value in epidemics The efficacy of S sonnei-rEPA was correlated with the level of vaccine-induced IgG antibodies
The highest incidence morbidity and mortality of shigellosis is in young children But serum antibody responsiveness to polysaccharide-based vaccines is age-dependent and infants and young children respond poorly or not at all to both disease and vaccination The safety and immunogenicity of these Shigella conjugates in 4 to 6 years-old children in Israel was demonstrated But although the fold rise in anti-LPS was similar in the children the level of anti-LPS elicited by the conjugates was lower than in adults We improved the immunogenicity of Shigella conjugates as shown in mice and then in adult humans Now we apply to evaluate the safety immunogenicity and efficacy of these improved conjugates in 1 to 4 years-old children in Israel
In Israel shigellosis is common especially in children S sonnei Group D comprise about 60 of the isolates followed by S flexneri Group B Shigella dysenteriae type 1 Group A is not found We propose to administer 2 injections of either S sonnei-CRM9 or S flexneri type 2a-rEPAsucc 6 weeks apart in a random double-blind fashion to about 6000 1 to 4 year-olds Active surveillance of the vaccinees for enteric infections will be maintained for at least 2 years to evaluate the effect of vaccination
Incomplete but compelling evidence indicates that a critical level of serum IgG anti-LPS confers immunity to shigellosis Important data come from our clinical trial in the Israel Defense Forces IDF recruits A randomized double-blind vaccine-controlled study showed that the S sonnei-rEPA elicited 74 protection against shigellosis occurring about 3 months after vaccination p0001 This vaccine conferred 43 p004 protection in one company during an outbreak up to 14 days following vaccination suggesting that our Shigella conjugates might be of value in epidemics The efficacy of S sonnei-rEPA was correlated with the level of vaccine-induced IgG antibodies
The highest incidence morbidity and mortality of shigellosis is in young children But serum antibody responsiveness to polysaccharide-based vaccines is age-dependent and infants and young children respond poorly or not at all to both disease and vaccination The safety and immunogenicity of these Shigella conjugates in 4 to 6 years-old children in Israel was demonstrated But although the fold rise in anti-LPS was similar in the children the level of anti-LPS elicited by the conjugates was lower than in adults We improved the immunogenicity of Shigella conjugates as shown in mice and then in adult humans Now we apply to evaluate the safety immunogenicity and efficacy of these improved conjugates in 1 to 4 years-old children in Israel
In Israel shigellosis is common especially in children S sonnei Group D comprise about 60 of the isolates followed by S flexneri Group B Shigella dysenteriae type 1 Group A is not found We propose to administer 2 injections of either S sonnei-CRM9 or S flexneri type 2a-rEPAsucc 6 weeks apart in a random double-blind fashion to about 6000 1 to 4 year-olds Active surveillance of the vaccinees for enteric infections will be maintained for at least 2 years to evaluate the effect of vaccination
Detailed Description:
Shigellosis remains a serious and frequent disease throughout the world Development of vaccines has been difficult because shigellae are habitants of and pathogens for humans only and there is no consensus about the mechanisms of immunity to this pathogen
Incomplete but compelling evidence indicates that a critical level of serum IgG anti-LPS confers immunity to shigellosis A randomized double-blind vaccine-controlled study in Israel Defense Force IDF recruits showed that the S sonnei-rEPA elicited 74 protection against shigellosis occurring about 3 months after vaccination p0001 This vaccine also conferred 43 p004 protection in one company during an outbreak up to 17 days following vaccination suggesting that our Shigella conjugates might be of value in epidemics The efficacy of S sonnei-rEPA was correlated with the level of vaccine-induced IgG antibodies
The highest incidence morbidity and mortality of shigellosis is in young children But serum antibody responsiveness to it is age dependent and infants and young children respond poorly or not at all to polysaccharide antigens following disease administration of attenuated strains of Shigella or vaccination with whole cell vaccines The safety and immunogenicity of similar Shigella conjugates in 4 to 7 years-old children in Israel was demonstrated But although the fold rise in anti-LPS was similar in the children the level of anti-LPS elicited by the conjugates was lower than in adults We improved the immunogenicity of Shigella conjugates as shown in mice and then in adult humans Now we apply to evaluate the safety immunogenicity and efficacy of these improved conjugates in 1 to 4 years-old children in Israel In addition to monitoring the safety and immunogenicity of the two investigational Shigella vaccines active surveillance of the vaccines for enteric infections wil be maintained for at lest 2 years to evaluate the effect of vaccination
Incomplete but compelling evidence indicates that a critical level of serum IgG anti-LPS confers immunity to shigellosis A randomized double-blind vaccine-controlled study in Israel Defense Force IDF recruits showed that the S sonnei-rEPA elicited 74 protection against shigellosis occurring about 3 months after vaccination p0001 This vaccine also conferred 43 p004 protection in one company during an outbreak up to 17 days following vaccination suggesting that our Shigella conjugates might be of value in epidemics The efficacy of S sonnei-rEPA was correlated with the level of vaccine-induced IgG antibodies
The highest incidence morbidity and mortality of shigellosis is in young children But serum antibody responsiveness to it is age dependent and infants and young children respond poorly or not at all to polysaccharide antigens following disease administration of attenuated strains of Shigella or vaccination with whole cell vaccines The safety and immunogenicity of similar Shigella conjugates in 4 to 7 years-old children in Israel was demonstrated But although the fold rise in anti-LPS was similar in the children the level of anti-LPS elicited by the conjugates was lower than in adults We improved the immunogenicity of Shigella conjugates as shown in mice and then in adult humans Now we apply to evaluate the safety immunogenicity and efficacy of these improved conjugates in 1 to 4 years-old children in Israel In addition to monitoring the safety and immunogenicity of the two investigational Shigella vaccines active surveillance of the vaccines for enteric infections wil be maintained for at lest 2 years to evaluate the effect of 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 |
|---|---|---|---|
| OH00-CH-N003 | REGISTRY | NICHD IRB | None |