Clinical trial: Persistence study

Community meetings were held at the study sites to inform and thank the people for their participation.

This is a follow-up study tracing subjects who participated in the clinical trials PsA-TT-002 and PsA-TT-003 in Mali, Senegal, and the Gambia four to five years ago in order to compare the longer-term immunogenicity of a single dose of the meningococcal A conjugate (PsA-TT) vaccine with that of the meningococcal A component of the licensed meningococcal ACWY polysaccharide vaccine. There are a total of 1,486 potential subjects.

Prior to the study start meetings were held to inform the communities of results of the clinical development so far and to thank them for their past and continued participation.

Study title: Evaluation of the antibody persistence in African subjects up to five years after immunization with MenAfriVac™, a meningococcal A conjugate vaccine

Primary end point: Meningococcal A antibody persistence

Secondary end point: Tetanus antibody persistence

Study results: Follow-up study

Vaccine manufacturer: Serum Institute of India, Ltd.

Country: Mali, Senegal, and the Gambia

Clinical site: (1) Center for Vaccine Development-Mali (CVD-Mali), Bamako, Mali; (2) Toucar Health Center/Institut de Recherche pour le Développement (IRD) Field Station of Niakhar, Senegal; (3) Medical Research Council (MRC) Laboratories, Basse, the Gambia

Principal investigators: (1) Samba Sow, MD; (2) Aldiouma Diallo, MD; (3) Beate Kampmann, MD

Number of subjects: 1,496 potential subjects

Start date: November 2011

Date of last subject last visit: Closeout visit scheduled summer 2012

Status: ongoing

Selected poster(s) and abstract(s)

 

Photo: Rodrigue Barry/WHO