Clinical trial: PsA-TT-001

Dr Préziosi receives a sign of blessing for the success of PsA-TT-001 as Dr Viviani, already blessed, looks on.

This was a Phase 1 clinical trial conducted at three sites in India. A total of 74 healthy adult volunteers aged 18 to 35 years were recruited to evaluate the safety profile of a single injection of meningococcal A conjugate (PsA-TT) vaccine during the four weeks postvaccination by comparison both to the meningitis A component of an existing meningococcal polysaccharide vaccine A/C, and to a tetanus toxoid vaccine. The immune response of a single dose of PsA-TT at 4 weeks and at 48 weeks after vaccination was also assessed.

Study title: A Phase I, double-blind, randomized study to evaluate the safety and immunogenicity of a new meningococcal A conjugate vaccine versus a meningococcal polysaccharide A+C reference vaccine and a tetanus toxoid control vaccine, given as single intramuscular injections in healthy adults from 18 to 35 years of age.

Primary end point: Safety

Secondary end point: Immunogenicity

Study results: The study showed that the PsA-TT vaccine was safe, well tolerated, and as immunogenic as the polysaccharide (unconjugated) vaccine.

Vaccine manufacturer: Serum Institute of India, Ltd.

Development stage: Phase 1

Country: India

Clinical sites: (1) King Edward Memorial (KEM) Hospital, Mumbai, India; (2) Nizam’s Institute of Medical Sciences, Hyderabad, India; (3) BYL Nair Charitable Hospital, Mumbai, India

Principal investigators: (1) Nilima Kshirsagar, MD, Mumbai, India; (2) Naidu Mur, MD, Hyderabad, India; (3) Urmila Thatte, MD, Mumbai, India

Number of subjects: 74 healthy adults

Start date: 18 August 2005

End date: 3 October 2006

Status: Completed

International Standard Randomized Controlled Trial Number: ISRCTN17662153

Selected publication(s)

Kshirsagar N, Mur N, Thatte U, et al. Safety, immunogenicity, and antibody persistence of a new meningococcal group A conjugate vaccine in healthy Indian adults. Vaccine. 2007;3(25) Suppl 1: A101–107.

Borrow R, Carlone G, Kshirsagar N, et al. A phase one, double-blind, randomized study to evaluate a new meningococcal group A conjugate vaccine in healthy Indian adults. Presented at: 15th International Pathogenic Neisseria Conference, 10–15 September 2006; Cairns, Queensland, Australia. Abstract # P8.1.06 (pdf 4.43 mb).

Bash M, Lynn F, Hammack C, et al. Neisseria meningitidis group A bactericidal activity assays using pooled human complement (pdf 63 kb). Presented at: 45th Infectious Diseases Society of America meeting, 4–7 October 2007; San Diego, United States.

Findlow H, Plikaytis B, Aase A, et al. Comparison and correlation of Neisseria meningitidis serogroup A immunologic assay results following one dose of meningococcal serogroup A conjugate vaccine in healthy Indian adults (pdf 425 kb). Presented at: 16th International Pathogenic Neisseria Conference, 7–12 September 2008; Rotterdam, the Netherlands. P216 (pdf 4.21 mb).

Ravenscroft N, Hearshaw M, Mensah P, et al. The application of physicochemical methods of analysis to the development of conjugate vaccines against meningococcal group A bacteria. Presented at: 15th International Pathogenic Neisseria Conference, 10–15 September 2006; Cairns, Queensland, Australia Abstract # P8.3.09 (pdf 4.43 mb).

Press release

View press release (pdf 74 kb).

Photo: Monique Berlier.