Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00271479
Status:
COMPLETED
Last Update Posted:
2006-12-22
First Post:
2005-12-29
Brief Title:
Fractional Dose Tetravalent A C Y W135 Meningococcal Polysaccharide Vaccine
Sponsor:
Epicentre
Organization:
Epicentre
Study Overview
Official Title:
Assay of the Immunogenicity of Fractional Dose Tetravalent A C Y W135 Meningococcal Polysaccharide Vaccine in Africa
Status:
COMPLETED
Status Verified Date:
2006-12
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:
Hypothesis
Lower doses of each ACYW135 component of the meningococcal polysaccharide vaccine could confer a similar functional immunogenic response as the dose of 50 μg currently being used and subsequently be equally protective
The purpose of this study is to evaluate the use of fractional dose tetravalent meningococcal polysaccharide vaccine to control outbreak especially caused by N meningitidis serogroup W135
Primary Objectives
To measure the immunogenicity of a dose corresponding to one fifth of the amount of the licensed meningococcal ACYW135 polysaccharide vaccine ie 10 μg for each component and
To measure the immunogenicity of a dose corresponding to one tenth of the licensed meningococcal ACYW135 polysaccharide vaccine ie 5 μg for each component
Lower doses of each ACYW135 component of the meningococcal polysaccharide vaccine could confer a similar functional immunogenic response as the dose of 50 μg currently being used and subsequently be equally protective
The purpose of this study is to evaluate the use of fractional dose tetravalent meningococcal polysaccharide vaccine to control outbreak especially caused by N meningitidis serogroup W135
Primary Objectives
To measure the immunogenicity of a dose corresponding to one fifth of the amount of the licensed meningococcal ACYW135 polysaccharide vaccine ie 10 μg for each component and
To measure the immunogenicity of a dose corresponding to one tenth of the licensed meningococcal ACYW135 polysaccharide vaccine ie 5 μg for each component
Detailed Description:
In 2002 an epidemic of meningococcal disease started in Burkina Faso and Neisseria meningitidis serogroup W135 was identified as the causative organism This event followed the outbreaks of 2000 and 2001 in Mecca Saudi Arabia and was the first large epidemic caused by serogroup W135 Mass vaccination of the population with the only vaccine protecting against W135 ie the tetravalent ACYW135 polysaccharide vaccine TPSV was not possible because of the global shortage in supply in addition to its cost In 2003 GlaxoSmithKline GSK produced a trivalent polysaccharide vaccine ACW135 for US 15 This vaccine was used in Burkina Faso in the new epidemic faced by this country in 2003 However availability and affordability of the tetravalent ACYW135 polysaccharide vaccine and of the trivalent ACW135 polysaccharide vaccine are still under discussion between the WHO and the producers The risk of further epidemics due to the W135 strain in other African countries is of high concern for the scientific community
The current dose of the licensed tetravalent ACYW135 polysaccharide vaccine contains 50 μg of each polysaccharide component During the 1980s researchers from the Walter Reed Army Institute of Research WRAIR did extensive works on the immunogenicity of meningococcal polysaccharide vaccines in adults A first study performed by Griffiss et al demonstrated that doses of 5 μg of group Y and group W135 polysaccharides were as effective as doses of 50 μg in inducing production of bactericidal antibody amounts correlating with functional immunity Griffiss et al Mil Med 1985 150 529-33 A second study concluded that doses of 75 μg Y and W and 15 μg A and C were sufficient to induce equivalent binding and bactericidal antibody responses as 50 μg Griffiss et al Infect Immun 1982 37 205-8 In a more recent study from Granoff et al 150 1 mcg of the ordinary dose of tetravalent ACYW135 vaccine was given Granoff et al J Infect Dis 1998 178 870-4 The antibody responses to A and C have been measured and this low dose was sufficient to mount a C response in most of the subjects but the dose was less effective in eliciting a response to A The antibody responses to W135 and Y were not reported
Hypothesis
Lower doses of each ACYW135 component of the meningococcal polysaccharide vaccine could confer a similar functional immunogenic response as the dose of 50 μg currently being used and subsequently be equally protective
It would potentially bring two major benefits Firstly it would increase the number of tetravalent vaccine doses available on the market Secondly it would decrease the cost of the individual vaccine dose As a result more people could be vaccinated and thereby protected against the disease and to a lower price
Results obtained with the study on the tetravalent ACYW135 polysaccharide vaccine would be valid for the trivalent ACW135 polysaccharide vaccine
The current dose of the licensed tetravalent ACYW135 polysaccharide vaccine contains 50 μg of each polysaccharide component During the 1980s researchers from the Walter Reed Army Institute of Research WRAIR did extensive works on the immunogenicity of meningococcal polysaccharide vaccines in adults A first study performed by Griffiss et al demonstrated that doses of 5 μg of group Y and group W135 polysaccharides were as effective as doses of 50 μg in inducing production of bactericidal antibody amounts correlating with functional immunity Griffiss et al Mil Med 1985 150 529-33 A second study concluded that doses of 75 μg Y and W and 15 μg A and C were sufficient to induce equivalent binding and bactericidal antibody responses as 50 μg Griffiss et al Infect Immun 1982 37 205-8 In a more recent study from Granoff et al 150 1 mcg of the ordinary dose of tetravalent ACYW135 vaccine was given Granoff et al J Infect Dis 1998 178 870-4 The antibody responses to A and C have been measured and this low dose was sufficient to mount a C response in most of the subjects but the dose was less effective in eliciting a response to A The antibody responses to W135 and Y were not reported
Hypothesis
Lower doses of each ACYW135 component of the meningococcal polysaccharide vaccine could confer a similar functional immunogenic response as the dose of 50 μg currently being used and subsequently be equally protective
It would potentially bring two major benefits Firstly it would increase the number of tetravalent vaccine doses available on the market Secondly it would decrease the cost of the individual vaccine dose As a result more people could be vaccinated and thereby protected against the disease and to a lower price
Results obtained with the study on the tetravalent ACYW135 polysaccharide vaccine would be valid for the trivalent ACW135 polysaccharide vaccine
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