title: Safety, immunogenicity, and antibody persistence of a new meningococcal group A conjugate vaccine in healthy Indian adults.
abstract: We performed a double-blind, randomized, controlled phase I study to assess safety, immunogenicity, and antibody persistence of the new meningococcal group A conjugate vaccine (PsA-TT) in healthy volunteers aged 18-35 years. Of the 74 male subjects enrolled, 24 received the PsA-TT vaccine (Group 1), 25 received the Meningococcal Polysaccharide Vaccine A+C, Pasteur, Lyon, France (Group 2), and 25 received the Tetanus Toxoid Vaccine Adsorbed, SIIL, Pune India (Group 3). No immediate reactions were observed. Local and systemic solicited reactions within 7 days post-vaccination and unsolicited adverse events (AEs) were mild and similar among the three groups and resolved without sequelae. No serious AEs were notified up to 1 year post-vaccination. Four weeks post-vaccination, a slightly higher proportion of Group 1 subjects had a four-fold increase in SBA titers compared to Group 2 subjects (83% versus 72%, p>0.05). SBA GMTs in Groups 2 and 3 were higher than in Group 3 (p<0.05). Serogroup A-specific IgG GMCs were significantly higher in Group 1 than in Groups 2 (p<0.05) and 3 (p<0.05). After 1 year SBA titers were significantly higher in Group 1 than in Group 2 (p<0.05). The new PsA-TT vaccine was shown to be safe, immunogenic, and able to elicit persistent functional antibody titers in adults. This opens the prospective for further development and licensure of this vaccine to eliminate epidemic meningitis in sub-Saharan Africa.
authors.affiliation: Seth G.S. Medical College & KEM Hospital Parel, Mumbai, India.
authors.forename: Nilima
authors.initials: N
authors.lastname: Kshirsagar
authors.forename: Naidu
authors.initials: N
authors.lastname: Mur
authors.forename: Urmila
authors.initials: U
authors.lastname: Thatte
authors.forename: Nithya
authors.initials: N
authors.lastname: Gogtay
authors.forename: Simonetta
authors.initials: S
authors.lastname: Viviani
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: Préziosi
authors.forename: Cheryl
authors.initials: C
authors.lastname: Elie
authors.forename: Helen
authors.initials: H
authors.lastname: Findlow
authors.forename: George
authors.initials: G
authors.lastname: Carlone
authors.forename: Ray
authors.initials: R
authors.lastname: Borrow
authors.forename: Varsha
authors.initials: V
authors.lastname: Parulekar
authors.forename: Brian
authors.initials: B
authors.lastname: Plikaytis
authors.forename: Prasad
authors.initials: P
authors.lastname: Kulkarni
authors.forename: Nathalie
authors.initials: N
authors.lastname: Imbault
authors.forename: F Marc
authors.initials: FM
authors.lastname: LaForce
mesh_terms: D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood / Q000276:immunology; D004311:Double-Blind Method; D006801:Humans; D007194:India; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D038381:Neisseria meningitidis, Serogroup A / Q000276:immunology*; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000737:chemistry / Q000276:immunology*
chemical_list: D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate