Meningococcal MeningitisPhase 2ETH-TVTNCT00994695
Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine
A Phase 2 study testing Mencevax ACW Vaccine in people with Meningococcal Meningitis, run by Armauer Hansen Research Institute, Ethiopia at 1 site in Ethiopia.
Trial summary
Primary objective: To assess the immunogenicity of the Mencevax ACW135 polysaccharide vaccine at 28 days (+6days) post vaccination in 2-4, 5-14, 15-29 year age groups and compare the immunogenicity between these age groups. Read more about this study
- Who is it for?
- Ages 2 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Meningitis
- What is being tested?
- Mencevax ACW Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 412 participants
- Where
- 1 siteEthiopia
- Study dates
- Nov 2005to Nov 2007
- Phase
- Phase 2
- 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 2 to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age between 2-29 years, both sexes, living in the selected villages of Butajira area
- A written informed consent signed by the individual (>=18y) or caretaker/guardian (2 to 17 years of age) as 18 is the legal age of maturity in Ethiopia. Assent from children/adolescents aged 12-17 years old.
- Free of obvious health problems ascertained by medical history and clinical examination on the day of enrolment
Who cannot join
- Those who are unlikely to complete the follow up at 4-weeks post-vaccination.
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of blood transfusion within 2 years prior to enrolment or planned use during the study period.
- Verbal report of previous vaccination with meningococcal serogroup A, C, Y or W135 vaccines since 1999.
- Confirmed or suspected immunosuppressive or immunodeficient condition including HIV infection.
- A family history of congenital or hereditary immunodeficiency.
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- History of allergic reaction to any component of the vaccine
- Presence of any fever (defined as axillary temperature of 37.5 degree centigrade or more) and/or severe illness on the day of enrolment/ vaccination.
- Pregnancy.
- lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Open and Parallel Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Polysaccharide Vaccine Comparing Three Groups: 2 - 4 Year, 5 - 14 Year and 15 - 29 Year Old Ethiopians
Primary objective:
To assess the immunogenicity of the Mencevax ACW135 polysaccharide vaccine at 28 days (+6days) post vaccination in 2-4, 5-14, 15-29 year age groups and compare the immunogenicity between these age groups.
Read more
Secondary Objectives:
- To estimate the incidence of common adverse events following immunization (AEFI) of GSK Nm ACW135 polysaccharide vaccine at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination
- To assess the persistence of antibody against meningitis A, C and W135 at 11 and 23 months post vaccination in 2-4, 5-14, 15-29 year age groups
Study site:Two rural communities (Kebele) in Butajira district, Ethiopia.
Methods:
- Phase II, open and parallel safety and immunogenicity trial.
- 234 younger children (2-4 years), 145 older children (5-14 years) and 33 adults (15-29 years of age) were randomly selected from the demographic surveillance database and enrolled after screening and consenting.
- Study participant received Mencevax ACW polysaccharide vaccine 50 mg in 0.5ml subcutaneously.
- Blood samples for measuring SBA titres were collected at pre vaccination and on day 28 (+6 days) post vaccination.
- Active follow up for AEFI on post vaccination day 0, 1, 2, 3, 7, \& 28.
- Primary end point was vaccine response defined as sero-conversion (in subjects initially seronegative) or a 4 fold increase (in subjects initially seropositive) in serum bactericidal antibodies (SBA) against serogroups Men A, C and W135) on post vaccination day 28. In addition seroconversion was assessed by ELISA Men A IgG on day 0 and day 28 post vaccination.
- Secondary endpoints were incidence of general and local symptoms and other adverse events following immunisation during the post vaccination period day 0 to 28 and immune persistence on post vaccination month-11 and month-23.
Results:
- No significant difference in the incidence of general or local AEFI was observed between the age groups
- The statistical analysis for the Immunogenicity data is in progress
- Conditions
- Meningococcal Meningitis
- Being tested
- Mencevax ACW Vaccine
- Keywords
- Trivalent meningococcal polysaccharide vaccine, Children, Safety, Immunogenicity, To assess Safety of trivalent meningococcal polysaccharide vaccine in children, To assess the immunogenicity of the trivalent polysaccharide vaccine in children
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mencevax ACW VaccineBiological
Also called Mencevax ACW polysaccharide vaccine
Mencevax ACW polysaccharide vaccine subcutaneously in the left arm at 50 μg in 0.5ml(reconstituted).
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate point estimates and trends in immunogenicity after not less than 28 days (+6 days) among children 2 - 4 years as compared to children 5 - 14 years and adolescents/adults 15 - 29 years (all ages inclusive)
Measured: 28 days
Secondary outcomes (2)
To assess the incidence of adverse events following vaccination at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination.
Measured: 28days
To assess the immunogenicity at 11 months and 23 months (inclusive) postvaccination.
Measured: 23 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startNov 2005
- Primary completionJan 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningococcal MeningitisStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armauer Hansen Research Institute, Ethiopia
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Addis Ababa University, London School of Hygiene and Tropical Medicine
- Investigators
- Abraham Aseffa Aseffa, M.D, PhD, Principal investigator, Senior Sientist,Deputy Director, AHRIAhmed Bedru Omer, M.D,Pediatrician, Principal investigator, Clinical Trial coordinator,AHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994695
- Sponsor's protocol ID
- AHRI/WHO/IVB-1
- Acronym
- ETH-TVT
- Status last verified
- Oct 2009
- First submitted
- 13 Oct 2009
- Last updated
- 16 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aseffa A, Bedru A, Yamuah L, Arga D, Worku A, Chandramohan D, Nelson CB, Engers HD. Safety of a trivalent meningococcal ACW135 vaccine among young children in Ethiopia. Vaccine. 2007 Sep 3;25 Suppl 1:A79-82. doi: 10.1016/j.vaccine.2007.04.046. Epub 2007 May 4.
PubMed 17548138
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open and Parallel Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Polysaccharide Vaccine Comparing Three Groups: 2 - 4 Year, 5 - 14 Year and 15 - 29 Year Old Ethiopians
- ClinicalTrials.gov ID
- NCT00994695
- Acronym / sponsor ID
- ETH-TVT / AHRI/WHO/IVB-1
- Conditions
- Meningococcal Meningitis
- Keywords
- Trivalent meningococcal polysaccharide vaccine, Children, Safety, Immunogenicity, To assess Safety of trivalent meningococcal polysaccharide vaccine in children, To assess the immunogenicity of the trivalent polysaccharide vaccine in children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Armauer Hansen Research Institute, EthiopiaUniversity, hospital or other
- Collaborators
- World Health Organization, Addis Ababa University, London School of Hygiene and Tropical Medicine
- Study start
- Nov 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 14 Oct 2009 (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.
Primary objective:
To assess the immunogenicity of the Mencevax ACW135 polysaccharide vaccine at 28 days (+6days) post vaccination in 2-4, 5-14, 15-29 year age groups and compare the immunogenicity between these age groups.
Secondary Objectives:
- To estimate the incidence of common adverse events following immunization (AEFI) of GSK Nm ACW135 polysaccharide vaccine at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination
- To assess the persistence of antibody against meningitis A, C and W135 at 11 and 23 months post vaccination in 2-4, 5-14, 15-29 year age groups
Study site:Two rural communities (Kebele) in Butajira district, Ethiopia.
Methods:
- Phase II, open and parallel safety and immunogenicity trial.
- 234 younger children (2-4 years), 145 older children (5-14 years) and 33 adults (15-29 years of age) were randomly selected from the demographic surveillance database and enrolled after screening and consenting.
- Study participant received Mencevax ACW polysaccharide vaccine 50 mg in 0.5ml subcutaneously.
- Blood samples for measuring SBA titres were collected at pre vaccination and on day 28 (+6 days) post vaccination.
- Active follow up for AEFI on post vaccination day 0, 1, 2, 3, 7, \& 28.
- Primary end point was vaccine response defined as sero-conversion (in subjects initially seronegative) or a 4 fold increase (in subjects initially seropositive) in serum bactericidal antibodies (SBA) against serogroups Men A, C and W135) on post vaccination day 28. In addition seroconversion was assessed by ELISA Men A IgG on day 0 and day 28 post vaccination.
- Secondary endpoints were incidence of general and local symptoms and other adverse events following immunisation during the post vaccination period day 0 to 28 and immune persistence on post vaccination month-11 and month-23.
Results:
- No significant difference in the incidence of general or local AEFI was observed between the age groups
- The statistical analysis for the Immunogenicity data is in progress
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age between 2-29 years, both sexes, living in the selected villages of Butajira area
- A written informed consent signed by the individual (>=18y) or caretaker/guardian (2 to 17 years of age) as 18 is the legal age of maturity in Ethiopia. Assent from children/adolescents aged 12-17 years old.
- Free of obvious health problems ascertained by medical history and clinical examination on the day of enrolment
Key exclusion criteria (10 listed)
- Those who are unlikely to complete the follow up at 4-weeks post-vaccination.
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of blood transfusion within 2 years prior to enrolment or planned use during the study period.
- Verbal report of previous vaccination with meningococcal serogroup A, C, Y or W135 vaccines since 1999.
- Confirmed or suspected immunosuppressive or immunodeficient condition including HIV infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mencevax ACW VaccineAlso: Mencevax ACW polysaccharide vaccineMencevax ACW polysaccharide vaccine subcutaneously in the left arm at 50 μg in 0.5ml(reconstituted). | Biological | – |
Primary outcome
To evaluate point estimates and trends in immunogenicity after not less than 28 days (+6 days) among children 2 - 4 years as compared to children 5 - 14 years and adolescents/adults 15 - 29 years (all ages inclusive)
Time frame: 28 days
2 secondary outcomes
To assess the incidence of adverse events following vaccination at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination.
Time frame: 28days
To assess the immunogenicity at 11 months and 23 months (inclusive) postvaccination.
Time frame: 23 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2009.
- Results publication: PubMed 17548138Aseffa A, Bedru A, Yamuah L, Arga D, Worku A, Chandramohan D, Nelson CB, Engers HD. Safety of a trivalent meningococcal ACW135 vaccine among young children in Ethiopia. Vaccine. 2007 Sep 3;25 Suppl 1:A79-82. doi: 10.1016/j.vaccine.2007.04.046. Epub 2007 May 4.
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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.
Abraham Aseffa Aseffa, M.D, PhD principal investigator
Senior Sientist,Deputy Director, AHRI
Ahmed Bedru Omer, M.D,Pediatrician principal investigator
Clinical Trial coordinator,AHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mencevax ACW Vaccine in people with Meningococcal Meningitis, run by Armauer Hansen Research Institute, Ethiopia at 1 site in Ethiopia.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 16 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate point estimates and trends in immunogenicity after not less than 28 days (+6 days) among children 2 - 4 years as compared to children 5 - 14 years and adolescents/adults 15 - 29 years (all ages inclusive) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00994695, which also lists 1 linked publication.
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 16 Oct 2009.