Clinical trial: PsA-TT-002
Town crier gathers the community to launch PsA-TT-002 clinical trial in Basse, the Gambia. |
This Phase 2 clinical trial was held in Mali and the Gambia to evaluate the immunogenicity and safety of a single injection of the meningococcal A conjugate (PsA-TT) vaccine in toddlers 12 to 23 months of age as compared to a licensed meningococcal ACWY polysaccharide vaccine and a licensed Haemophilus influenzae (Hib) conjugate vaccine. Immunological memory and persistence of antibodies were also evaluated. A total of 601 subjects were enrolled.
Study title: A Phase II, observer-blind, randomized, active controlled study to compare the safety, immunogenicity, and induction of immunological memory of a meningococcal A conjugate vaccine, a meningococcal ACWY polysaccharide vaccine and a Hib conjugate vaccine, administered in healthy toddlers 12–23 months of age.
Primary end point: Immunogenicity
Secondary end point: Safety
Study results: Results show that the vaccine is safe and produces antibody levels almost 20 times higher than those obtained with the polysaccharide (unconjugated) vaccine. See Sow S, Okoko B, Diallo A, et al. Immunogenicity and safety of a meningococcal A conjugate vaccine in Africans. New England Journal of Medicine. 2011; 364:2293–2304.
Vaccine manufacturer: Serum Institute of India, Ltd.
Development stage: Phase 2
Countries: Mali and the Gambia
Clinical sites: (1) Center for Vaccine Development-Mali (CVD-Mali), Bamako, Mali; (2) Medical Research Council (MRC) Laboratories, Basse, the Gambia
Principal investigators: (1) Samba Sow, MD; (2) Brown Okoko, MD, and Adebayo Akinsola, MD
Number of subjects: 601 subjects, aged between 12 and 23 months
Start date: 11 September 2006
Date of last subject last visit: 6 April 2009
Status: Completed
International Standard Randomized Controlled Trial Number: ISRTCN78147026
Selected poster(s) and abstract(s)
Bash M, Sow S, Okoko B, et al. A Phase 2 safety and immunogenicity study of a new meningococcal group A conjugate vaccine in healthy African toddlers residing in the meningitis belt (pdf 580 kb). Presented at: 45th Infectious Diseases Society of America meeting, 4–7 October 2007; San Diego, United States.
Bash M, Sow S, Okoko B, et al. Human complement serum bactericidal activity following vaccination in a Phase 2 safety and immunogenicity study of a new meningococcal group A conjugate vaccine in healthy African toddlers residing in the meningitis belt (pdf 192 kb). Presented at: 16th International Pathogenic Neisseria Conference, 7–12 September 2008; Rotterdam, the Netherlands. P223 (pdf 4.21 mb).
Idoko O, Okoko B, Sow S, et al. Safety and immunogenicity of a new meningococcal A conjugate vaccine in a healthy African population aged 2–29 years. Presented at: 13th International Society for Infectious Diseases meeting, 19–22 June 2008; Kuala Lumpur, Malaysia.
Mattick C, Martino A, Tiengwe C, et al. Quality and immunogenicity of MenAfriVac, a conjugate vaccine against meningococcal group A disease (pdf 1.96 mb). Presented at: Royal Society of Hygiene and Tropical Medicine Centenary meeting, 13–15 September 2007; London, United Kingdom.
Okoko B, Sow S, Préziosi M-P, et al. A Phase II randomized study to evaluate the safety and immunogenicity of a new meningococcal group A conjugate vaccine in healthy African toddlers residing in the meningitis belt: a preliminary report (pdf 306 kb). Presented at: Royal Society of Hygiene and Tropical Medicine Centenary meeting, 13–15 September 2007; London, United Kingdom.
Okoko B, Sow S, Tapia M, et al. A phase II clinical study to evaluate the safety, immunogenicity and immunological memory of a new group A meningococcal conjugate vaccine in healthy African children (pdf 3.65 mb). Presented at: 16th International Pathogenic Neisseria Conference, 7–12 September 2008; Rotterdam, the Netherlands. P211 (pdf 4.21 mb).
Sow S, Okoko B, Préziosi M-P, et al. Une étude de phase 2, randomisée, en double aveugle pour évaluer la tolérance et l'immunogénicité d'un nouveau vaccin conjugué antiméningococcique A chez de jeunes enfants africains sains résidant au sein de la ceinture africaine de la méningite (pdf 219 kb). Presented at: XIIIe Actualités du Pharo, 6–8 September 2007; Marseille, France.
Sow S, Okoko B, Diallo A, et al. Immunogenicity and safety of a meningococcal A conjugate vaccine in Africans. New England Journal of Medicine. 2011; 364:2293–2304.
Press release
View press release (pdf 68 kb).
Photo: Julie Chaumont.
