%0 Journal Article %1 kshirsagar_safety_2007 %A Kshirsagar, Nilima %A Mur, Naidu %A Thatte, Urmila %A Gogtay, Nithya %A Viviani, Simonetta %A Préziosi, Marie-Pierre %A Elie, Cheryl %A Findlow, Helen %A Carlone, George %A Borrow, Ray %A Parulekar, Varsha %A Plikaytis, Brian %A Kulkarni, Prasad %A Imbault, Nathalie %A LaForce, F Marc %D 2007 %J Vaccine %K A, Adolescent, Adult, Antibodies, Bacterial, Conjugate Humans, India, Male, Meningococcal Method, Neisseria Serogroup Vaccines, meningitidis, {Double-Blind} %P A101--7 %R S0264-410X(07)00475-6 %T Safety, immunogenicity, and antibody persistence of a new meningococcal group A conjugate vaccine in healthy Indian adults %V 25 Suppl 1 %X 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\textgreater0.05). SBA GMTs in Groups 2 and 3 were higher than in Group 3 (p\textless0.05). Serogroup A-specific IgG GMCs were significantly higher in Group 1 than in Groups 2 (p\textless0.05) and 3 (p\textless0.05). After 1 year SBA titers were significantly higher in Group 1 than in Group 2 (p\textless0.05). 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.

@article{kshirsagar_safety_2007, 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{\textgreater}0.05). {SBA} {GMTs} in Groups 2 and 3 were higher than in Group 3 (p{\textless}0.05). Serogroup A-specific {IgG} {GMCs} were significantly higher in Group 1 than in Groups 2 (p{\textless}0.05) and 3 (p{\textless}0.05). After 1 year {SBA} titers were significantly higher in Group 1 than in Group 2 (p{\textless}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.}, added-at = {2011-03-11T10:05:34.000+0100}, author = {Kshirsagar, Nilima and Mur, Naidu and Thatte, Urmila and Gogtay, Nithya and Viviani, Simonetta and Préziosi, {Marie-Pierre} and Elie, Cheryl and Findlow, Helen and Carlone, George and Borrow, Ray and Parulekar, Varsha and Plikaytis, Brian and Kulkarni, Prasad and Imbault, Nathalie and {LaForce}, F Marc}, biburl = {https://www.bibsonomy.org/bibtex/248fec48e9716eed3a11ca17af7201cf3/jelias}, doi = {S0264-410X(07)00475-6}, interhash = {c11b8402889e825b8fd71a53d9f7d078}, intrahash = {48fec48e9716eed3a11ca17af7201cf3}, issn = {{0264-410X}}, journal = {Vaccine}, keywords = {A, Adolescent, Adult, Antibodies, Bacterial, Conjugate Humans, India, Male, Meningococcal Method, Neisseria Serogroup Vaccines, meningitidis, {Double-Blind}}, month = sep, note = {{PMID:} 17532101}, pages = {A101--7}, timestamp = {2011-03-11T10:06:15.000+0100}, title = {Safety, immunogenicity, and antibody persistence of a new meningococcal group A conjugate vaccine in healthy Indian adults}, volume = {25 Suppl 1}, year = 2007 }