Infections, Meningococcal Clinical Trial
Official title:
Assay of the Immunogenicity of Fractional Dose Tetravalent A, C, Y, W135 Meningococcal Polysaccharide Vaccine in Africa
Hypothesis:
Lower doses of each A/C/Y/W135 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 A/C/Y/W135 polysaccharide vaccine, i.e. 10 μg for each
component; and
- To measure the immunogenicity of a dose corresponding to one tenth of the licensed
meningococcal A/C/Y/W135 polysaccharide vaccine, i.e. 5 μg for each component.
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, i.e. the tetravalent A/C/Y/W135 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 A/C/W135 for US$ 1.5. This
vaccine was used in Burkina Faso in the new epidemic faced by this country in 2003. However,
availability and affordability of the tetravalent A/C/Y/W135 polysaccharide vaccine and of
the trivalent A/C/W135 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 A/C/Y/W135 polysaccharide vaccine contains 50
μg of each polysaccharide component. During the 1980’s, 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 7.5 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., 1/50 (1 mcg) of the ordinary dose of
tetravalent A/C/Y/W135 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 A/C/Y/W135 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 A/C/Y/W135 polysaccharide vaccine would
be valid for the trivalent A/C/W135 polysaccharide vaccine.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03652610 -
A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adults 18 to 40 Years of Age
|
Phase 2 | |
Completed |
NCT02223637 -
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
|
||
Completed |
NCT00974363 -
Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
|
Phase 3 | |
Completed |
NCT00196950 -
Study to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 Years
|
Phase 2 | |
Completed |
NCT00514904 -
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
|
Phase 3 | |
Completed |
NCT02173704 -
Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan.
|
Phase 3 | |
Completed |
NCT01641042 -
Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects
|
Phase 3 | |
Completed |
NCT01682876 -
Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.
|
Phase 3 | |
Completed |
NCT00758264 -
Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration
|
Phase 3 | |
Completed |
NCT01962207 -
The Long-term Antibody Persistence of MenACWY-TT Vaccine (PF-06866681) Versus Meningitec(Registered) or Mencevax(Registered) ACWY in Healthy Adolescents and Adults and a Booster Dose of MenACWY-TT Administered 10 Years Post Primary Vaccination
|
Phase 3 | |
Completed |
NCT00718666 -
The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers
|
Phase 2 | |
Completed |
NCT01939158 -
Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine
|
Phase 3 | |
Completed |
NCT01235975 -
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years
|
Phase 3 | |
Active, not recruiting |
NCT05082285 -
A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants
|
Phase 2 | |
Completed |
NCT02446743 -
Combined Study - Phase 3b MenB Long Term Persistence in Adolescents
|
Phase 3 | |
Completed |
NCT02946385 -
Study to Assess the Immunological Long-term Persistence of Antibodies (Abs) 2 Years After GlaxoSmithKline (GSK) Meningococcal ABCWY Vaccination in the V102_15 (NCT02212457) and Response to a Booster in Adolescents
|
Phase 2 | |
Completed |
NCT00674583 -
Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children
|
Phase 3 | |
Completed |
NCT01777308 -
Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine Administered 6 Years Post-MenC Primary Vaccination in Healthy Subjects Who Were 12-18 Months at Primary Vaccination
|
Phase 3 | |
Completed |
NCT00464815 -
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects
|
Phase 3 | |
Completed |
NCT00661557 -
Comparison of GSK134612 in Subjects Previously Vaccinated Against Meningococcal Disease Versus Non-vaccinated Subjects
|
Phase 2 |