- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01303211
A Case-control Study of the Efficacy of a New Serogroup A Meningococcal Conjugate Vaccine (MenAfriVac) in Mali and Niger (VES)
Study Overview
Status
Conditions
Detailed Description
Massive epidemics of meningococcal disease continue to occur every few years in countries of the African Sahel and sub-Sahel - the African meningitis belt. In 2009 there were more than 50,000 reported cases in Nigeria alone. Most of these epidemics are caused by meningococci belonging to capsular polysaccharide serogroup A. African epidemics can be contained by existing meningococcal polysaccharide vaccines, saving many lives, but epidemics are not prevented by use of these vaccines. Recently, a new serogroup A meningococcal polysaccharide/protein conjugate vaccine (MenAfriVac), which may be able to prevent epidemics, was prequalified by the World Health Organization. This vaccine was developed by the Meningitis Vaccine Project (MVP) and is being produced at a cost ($0.40 per dose) that is affordable by countries of the African meningitis belt. Mass vaccination campaigns started in Burkina Faso, Mali and Niger at the end of 2010. Full coverage will be achieved in 2011 with progressive deployment to other countries in the meningitis belt.
The safety and immunogenicity of MenAfriVac have been established through phase 1 and phase 2 trials conducted in India and Africa but no efficacy trials have been undertaken. Prequalification was granted on the assumption that the high level of immunogenicity demonstrated in African populations would be reflected by a similar degree of efficacy. This is likely, but it is important that the efficacy of this vaccine is established definitively before large sums are spent on deploying the vaccine across the African meningitis belt. Therefore, a case control study to determine the efficacy of MenAfriVac in preventing serogroup A meningococcal meningitis in Mali and Niger is proposed.
A case-control study will be conducted in Mali and in Niger during the 2011, 2012 and 2013 meningitis seasons. Cases of meningitis will be detected through existing routine surveillance systems and their etiology established using standard microbiology or rapid diagnostic tests. Cases of proven serogroup A meningococcal meningitis (culture, antigen or PCR positive) will be matched with two hospital and two community controls who will, in turn, be matched with the cases for age and place of residence. A questionnaire will be administered to cases and controls which asks about previous meningococcal vaccination and other risk factors for meningococcal disease which might confound or modify assessment of the impact of vaccination with MenAfriVac. A blood sample will be collected for measurement of serogroup A meningococcal bactericidal and tetanus antibodies, as well as total immunoglobulin levels. Determination of vaccination status will be facilitated by the fact that vaccination cards will be issued to all recipients at the time of vaccination by the mass vaccination teams. Vaccine efficacy will be determined by comparing the odds of exposure to MenAfriVac in cases and controls.
Study Type
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Cases: Patients with serogroup A meningococcal meningitis
Hospital controls: Patients admitted to the same hospital/health facility as the case with an acute illness other than meningitis or septicemia.
Community controls:Healthy individuals recruited from the same community as the case
Description
Inclusion Criteria:
- Cases: i)consent to participate; ii) Laboratory confirmed serogroup A meningococcal disease established by examination of the CSF (turbid CSF or a white cell > 10 per ul) and evidence of a serogroup A meningococcal infection established by (a) culture of serogroup A meningococci from the cerebrospinal fluid, blood or other normally sterile fluid, (b) a positive CSF latex test for serogroup A meningococcal antigen, (c) a positive serogroup A dipstick assay or (d) a positive CSF PCR for serogroup A meningococcal infection; iii) 1 to 29 years old.
iii) In target 1-29 year age group at the time of vaccination with MenAfriVac.
- Hospital controls: i)consent to participate; ii)patients admitted to the hospital with an acute illness other than meningitis, matched to cases for age and sex
-Community controls: i)consent to participate; ii)Healthy members of the community, matched to cases for age and sex
Exclusion Criteria:
Case:
i)Refusal to participate in the study; ii) infants<1 year old and adults>29 years old
Hospital controls:
i)Refusal to participate in the study; ii)Previous history of meningitis; iii) Presence of symptoms that could indicate meningitis
Community controls:
i)Refusal to participate in the study; ii)Previous history of meningitis; iii) Presence of symptoms that could indicate meningitis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
serogroup A meningococcal disease
Cases of serogroup A meningococcal disease
|
Community controls
Healthy members of the community controls matched with cases for age, sex and place of residence
|
Hospital controls
Patients admitted to the hospital with an acute illness other than meningitis or septicemia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serogroup A meningococci disease
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: James Stuart, MD, London School of Hygiene and Tropical Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VES_5840
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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