Meningococcal DiseaseVESNCT01303211
A Case-control Study of the Efficacy of a New Serogroup A Meningococcal Conjugate Vaccine (MenAfriVac) in Mali and Niger
An observational study of Meningococcal Disease, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
Trial summary
Major epidemics of meningococcal meningitis occur in countries of the African Sahel and sub-Sahel every few years. Most of these epidemics are caused by meningococci belonging to serogroup A. Read more about this study
- Who is it for?
- Ages 1 year to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2012to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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.
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Major epidemics of meningococcal meningitis occur in countries of the African Sahel and sub-Sahel every few years. Most of these epidemics are caused by meningococci belonging to serogroup A. Until recently there has been no serogroup A conjugate vaccine available to prevent epidemics in Africa because none of the major pharmaceutical companies wanted to develop such a vaccine for commercial reasons. For this reason a public private partnership was established in 2001, the Meningitis Vaccine Project (MVP), with support from the Bill and Melinda Gates Foundation, to develop an affordable new serogroup A meningococcal conjugate vaccine for Africa. The new vaccine, MenAfriVac™, received WHO pre-qualification in 2010 and mass campaigns started in Burkina Faso, Mali and Niger in 2010. It is expected that full coverage through mass vaccination campaigns will be achieved by the end of 2011 in these three countries. A case-control study will be conducted in Mali and Niger during the epidemic seasons of 2012 and 2013 to assess the efficacy of MenAfriVac™.
Read the 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.
- Conditions
- Meningococcal Disease
- Keywords
- Meningococcal serogroup A conjugate vaccine, Vaccine efficacy, Serogroup A meningococcal diseases
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
serogroup A meningococci disease
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startFeb 2012
- Primary completionMay 2013 (estimated)
- Study completionNov 2013 (estimated)
Why it stopped: No cases on NmA meningitis were recorded following vaccination with MenAfriVac
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Brian Greenwood, MD, Principal investigator, London School of Hygiene and Tropical MedicineJames Stuart, MD, Study director, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303211
- Sponsor's protocol ID
- VES_5840
- Acronym
- VES
- Status last verified
- Feb 2013
- First submitted
- 8 Feb 2011
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-control Study of the Efficacy of a New Serogroup A Meningococcal Conjugate Vaccine (MenAfriVac) in Mali and Niger
- ClinicalTrials.gov ID
- NCT01303211
- Acronym / sponsor ID
- VES / VES_5840
- Conditions
- Meningococcal Disease
- Keywords
- Meningococcal serogroup A conjugate vaccine, Vaccine efficacy, Serogroup A meningococcal diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No cases on NmA meningitis were recorded following vaccination with MenAfriVac
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Feb 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Major epidemics of meningococcal meningitis occur in countries of the African Sahel and sub-Sahel every few years. Most of these epidemics are caused by meningococci belonging to serogroup A. Until recently there has been no serogroup A conjugate vaccine available to prevent epidemics in Africa because none of the major pharmaceutical companies wanted to develop such a vaccine for commercial reasons. For this reason a public private partnership was established in 2001, the Meningitis Vaccine Project (MVP), with support from the Bill and Melinda Gates Foundation, to develop an affordable new serogroup A meningococcal conjugate vaccine for Africa. The new vaccine, MenAfriVac™, received WHO pre-qualification in 2010 and mass campaigns started in Burkina Faso, Mali and Niger in 2010. It is expected that full coverage through mass vaccination campaigns will be achieved by the end of 2011 in these three countries. A case-control study will be conducted in Mali and Niger during the epidemic seasons of 2012 and 2013 to assess the efficacy of MenAfriVac™.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 year to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (4 listed)
- 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.
- 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
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serogroup A meningococci disease
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
Related trials for Meningococcal Disease
Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Greenwood, MD principal investigator
London School of Hygiene and Tropical Medicine
James Stuart, MD study director
London School of Hygiene and Tropical Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningococcal Disease, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mali, Niger. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serogroup A meningococci disease (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.