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.
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
Publication(s)
Marchetti E, Mazarin-Diop V, Chaumont J, et al. Conducting vaccine clinical trials in sub-Saharan Africa: operational challenges and lessons learned from the Meningitis Vaccine Project. Vaccine. 2012;30(48):6859–6863.
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.
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.
Press release
View press release (pdf 68 kb).
Photo: Julie Chaumont.
