Long-term follow-up of children who participated at 9-12 months of age in clinical trial PsA-TT-007 in Mali
| ISRCTN | ISRCTN37623829 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37623829 |
| Secondary identifying numbers | Pers-007 |
- Submission date
- 09/12/2016
- Registration date
- 19/12/2016
- Last edited
- 29/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
MenAfriVac is a vaccine used for preventing disease caused by meningococcus A germs. This germ can cause meningitis, an infection in the brain and in blood. Meningitis can cause brain damage, deafness, loss of limbs and even death. In Mali, meningitis occurs in a large number of people during the dry season every year. There are many groups of meningococcus germs. These groups are identified by different letters (including A, B, C, W-135, X and Y). Group A causes the majority of meningitis in Mali. MenAfriVac has been given to millions of people in many African countries including Mali. MenAfriVac (10µg) was the vaccine used in Mali’s 2010 national campaign for 1-29 year olds. It will be used again in 2017 for the catch-up campaign for 1-5 year olds (born after the first campaign). There is also a half-dose (5µg) of this vaccine called MenAfriVac5. MenAfriVac5 will now be offered to all infants at 9 months of age in Mali. A previous study called Study PSA-TT-007 looked at the 5µg and 10µg doses of MenAfriVac between March 2012 and September 2013 in Mali. The aim of the current study is to collect information on the antibodies (protective substances against meningococcus A and other diseases) in former PsA-TT-007 participants’ blood, as well unvaccinated children of the same age.
Who can participate?
Children under 6 years of age who took part in Study PsA-TT-007 and unvaccinated children of the same age.
What does the study involve?
All participants have a blood sample taken piror to the national catch-up campaign. The blood will be tested in a lab to check for antibodies against meningococcus A. In a random sample of participants, two further samples will be taken 28 days and 6 months following the catch-up campaign.
What are the possible benefits and risks of participating?
There are no direct benefits from taking part in the study. There are no notable risks to participating other than possible discomfort during blood collection.
Where is the study run from?
Center for Vaccine Development Mali (Mali)
When is the study starting and how long is it expected to run for?
May 2014 to December 2017
Who is funding the study?
Bill and Melinda Gates Foundation (USA)
Who is the main contact?
Ms Corey Kelly
Contact information
Public
Center for Vaccine Innovation and Access
PATH
2201 Westlake Avenue
Suite 200
Seattle
98121
United States of America
| Phone | +1 206 225 8386 |
|---|---|
| nbhat@path.org |
Study information
| Study design | Longitudinal observational epidemiological study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Epidemiological study |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | A Phase IV, open-label, controlled study to evaluate the up-to-four-year antibody persistence among Malian children who previously received different doses and schedules of meningococcal conjugate group A vaccine (PsA-TT 5μg or 10μg) between 9 and 18 months of age and to assess the boosting effect following a catch-up campaign dose of MenAfriVac® (PsA-TT 10μg) |
| Study objectives | Group A meningococcal serum antibodies will persist in children approximately four years after receipt of one or two doses of PsA-TT (5μg or 10μg polysaccharide concentration) initiated at 9-12 months of age. |
| Ethics approval(s) | University of Maryland, Baltimore, Institutional Review Board, 30/11/2016, ref: HP-00072598 |
| Health condition(s) or problem(s) studied | Meningococcal serogroup A |
| Intervention | Serum anti-MenA antibody levels will be measured in study participants at one or three time points, for controls as well as former PsA-TT-007 participants. The first blood draw will be performed on the day of enrollment, prior to the Mali national catch-up campaign for MenAfriVac. In a random subset of 280 participants, a second follow-up visit will be scheduled approximately 28 days after receiving a dose of MenAfriVac through the national catch-up campaign, and a third visit will be scheduled approximately 6 months after receiving the campaign dose. |
| Intervention type | Other |
| Primary outcome measure | Geometric mean titer (GMT) for MenA-specific serum antibody as measured by serum bactericidal antibody assay using rabbit complement (rSBA) approximately four years following primary immunization. |
| Secondary outcome measures | With respect to the immune persistence time point, which will occur approximately four years following primary immunization: 1. The percentage of participants with a MenA antibody titer ≥ 1:8, and ≥ 1:128, as measured by rSBA assay 2. The geometric mean concentrations (GMC) for serogroup A-specific IgG concentrations, as measured by ELISA 3. The percentage of participants with serogroup A-specific IgG concentration ≥ 2 μg/ml, and ≥ 1 μg/ml, as measured by ELISA Meningitis A Vaccine Sustainability Project 4. The reverse cumulative distribution curves for MenA antibody titers as measured by rSBA assay, and for MenA-specific IgG concentrations as measured by ELISA With respect to the time points of approximately 28 days and 180 days following receipt of a single dose of MenAfriVac through a national catch-up campaign: 1. The geometric mean titer (GMT) for MenA-specific serum antibody, as measured by rSBA assay 2. The percentage of participants demonstrating a ≥ 4-fold rise (i.e. seroconversion) in MenA antibody titers, when compared to the pre-campaign (persistence) timepoint titer, as measured by rSBA assay 3. The geometric mean concentrations (GMC) for MenA-specific IgG concentrations, as measured by ELISA 4. The ratio of GMC for MenA-specific IgG concentration in relation to the pre-campaign (persistence) time point, as measured by ELISA 5. The percentage of participants who demonstrate a ≥ 2-fold rise and a ≥ 4-fold rise in MenA-specific IgG concentration (i.e. seroconversion) with respect to pre-campaign (persistence) MenA-specific IgG concentration, as measure by ELISA 6. The percentage of participants with a MenA antibody titer ≥ 1:8, and ≥ 1:128, as measured by rSBA assay 7. The percentage of participants with MenA-specific IgG concentration ≥ 2 μg/ml, and ≥ 1 μg/ml, as measured by ELISA 8. The reverse cumulative distribution curves for MenA antibody titers as measured by rSBA assay and for MenA-specific lgG concentrations as measured by ELISA |
| Overall study start date | 01/05/2014 |
| Completion date | 01/12/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Upper age limit | 6 Years |
| Sex | Both |
| Target number of participants | 825 |
| Key inclusion criteria | Former Study PsA-TT-007 participants: 1. Received study vaccine (PsA-TT 5μg or 10μg) 2. Final evaluable blood collection must have been completed within 3 months after the second vaccination 3. Younger than 6 years of age as of March 1st, 2017 4. Written informed consent obtained from the participants’ parent(s) or guardian following international ethical guidelines for epidemiological studies and applicable local ethical guidance and requirements (added 27/02/2017) Control participants: 1. Born between March 2011 and March 2012 2. No evidence of chronic disease 3. Younger than 6 years of age as of March 1st, 2017 4. Written informed consent obtained from the participants’ parent(s) or guardian following international ethical guidelines for epidemiological studies and applicable local ethical guidance and requirements (added 27/02/2017) |
| Key exclusion criteria | Exclusion criteria as of 27/02/2017: 1. Received meningococcal vaccination outside the PsA-TT-007 study (all participants, conjugate or polysaccharide) 2. Any chronic condition or medical/hereditary history suggesting participant would be immunocompromised (i.e. primary immunodeficiency, HIV, autoimmune disease) 3. Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying agents within the past three months (including systemic or inhaled corticosteroids, this means prednisone or equivalent, ≥0.5 mg/kg/day; topical steroids are allowed) 4. Administration of immunoglobulins and/or any blood products within the last 90 days. 5. Residence outside the study area for any prolonged period since birth (at the discretion of the PI) such that the potential for exposure to circulating N. meningitidis serogroup A may differ from the rest of the population (control participants only) 6. Intent to move out of the study population within the period of study conduct 7. Any condition or criteria that in the opinion of the investigator might compromise the well-being of the participant or compliance with study procedures or interfere with the outcome of the study Original exclusion criteria: Former Study PsA-TT-007 participants: 1. Received meningococcal vaccination outside the PsA-TT-007 study (all participants, conjugate or polysaccharide) 2. Any chronic condition or medical/hereditary history suggesting participant would be immunocompromised (i.e. primary immunodeficiency, HIV, autoimmune disease) 3. Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying agents within the past three months (including systemic or inhaled corticosteroids, this means prednisone or equivalent, ≥0.5 mg/kg/day; topical steroids are allowed) 4. Administration of immunoglobulins and/or any blood products within the last 90 days. Control participants: 1. Residence outside the study area for any prolonged period since birth (at the discretion of the PI) such that the potential for exposure to circulating N. meningitidis serogroup A may differ from the rest of the population 2. Intent to move out of the study population within the period of study conduct 3. Any condition or criteria that in the opinion of the investigator might compromise the well-being of the participant or compliance with study procedures or interfere with the outcome of the study |
| Date of first enrolment | 06/12/2016 |
| Date of final enrolment | 06/03/2017 |
Locations
Countries of recruitment
- Mali
Study participating centre
CVD-MALI Ex Institut Marchoux
Djicoroni Para Avenue Mohamed VI
Bamako
BP251
Mali
Sponsor information
Other
2201 Westlake Avenue
Suite 200
Seattle
98121
United States of America
| Phone | +1 206 285 3500 |
|---|---|
| media@path.org | |
| Website | www.path.org |
"ROR" |
https://ror.org/02ycvrx49 |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 16/10/2020 | 23/10/2020 | No | No |
Additional files
- ISRCTN37623829_BasicResults_16Oct2020.pdf
- uploaded 23/10/2020
Editorial Notes
29/10/2020: The study contact was changed.
23/10/2020: The basic results of this trial have been uploaded as an additional file.
27/02/2017: The following changes have been made to the record:
1. The overall trial end date has been updated from 31/12/2017 to 01/12/2017
2. The recruitment dates have been updated from 07/12/2016 - 27/02/2017 to 06/12/2016 - 06/03/2017
3. The inclusion and exclusion criteria have been updated
4. The plain English summary has been edited to reflect the above changes
