Meningococcal A disease Nervous System Diseases
Conditions
Interventions
Former PsA-TT-004 participants previously received either a two dose regimen of PsA-TT (2.5, 5, or 10 µg dosage) at 14 to 18 weeks and 9 to 12 months of age or a single dose of 10 µg PsA-TT at 9 to 12
Sponsors
Program for Appropriate Technology in Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Enrolled in the initial study intervention group and completed the final blood draw at 36 weeks OR 2. Received at age 12-18 months (inclusive) a single dose of MenAfriVac® during the national campaign in 2012 (new control group)
Exclusion criteria
Exclusion criteria: 1. Any chronic condition or medical/hereditary history suggesting subject would be immuno-compromised (i.e. HIV, autoimmune disease) 2. Non-residence in the study area or intent to move out within one year (new control group only) 3. Any condition or criteria that in the opinion of the investigator might compromise the well-being of the subject or the compliance with study procedures or interfere with the outcome of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Meningococcal A antibody persistence will be assessed one year after recruitment and then again a year later, in terms of geometric mean titer (GMT) of meningococcal A antibody titers as measured by rSBA assay for each study group (groups 1A, 1B, 1C, 2, and 3 from the original PsA-TT-004 study and a new control group). | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of subjects who have a 4-fold or higher response in MenA antibody titer with respect to pre-immunization MenA antibody titer (from initial study), as measure by rSBA assay will be determined one year after recruitment and then again a year later. | — |
Countries
Ghana
Outcome results
None listed