Safety, immunogenicity, and antibody persistence of a new meningococcal group A conjugate vaccine in healthy Indian adults

Nilima Kshirsagar; Naidu Mur; Urmila Thatte; Nithya Gogtay; Simonetta Viviani; Marie Pierre Préziosi; Cheryl Elie; Helen Findlow; George Carlone; Raymond Borrow; Varsha Parulekar; Brian Plikaytis; Prasad Kulkarni; Nathalie Imbault; F. Marc LaForce

doi:10.1016/j.vaccine.2007.04.050

Safety, immunogenicity, and antibody persistence of a new meningococcal group A conjugate vaccine in healthy Indian adults

Nilima Kshirsagar, Naidu Mur, Urmila Thatte, Nithya Gogtay, Simonetta Viviani^*, Marie Pierre Préziosi, Cheryl Elie, Helen Findlow, George Carlone, Raymond Borrow, Varsha Parulekar, Brian Plikaytis, Prasad Kulkarni, Nathalie Imbault, F. Marc LaForce

^*Corresponding author for this work

Manchester Meningococcal Reference Unit General

Research output: Contribution to journal › Article › peer-review

72 Citations (Scopus)

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 Meningoccoccal 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.

Original language	English
Pages (from-to)	A101-A107
Journal	Vaccine
Volume	25
Issue number	SUPPL. 1
DOIs	https://doi.org/10.1016/j.vaccine.2007.04.050
Publication status	Published - 3 Sept 2007

Bibliographical note

Funding Information:
This study was funded by the Meningitis Vaccine Project ( http://www.meningvax.org ).

Funding Information:
Epidemics of group A Neisseria meningitidis are a major unresolved public health problem in sub-Saharan Africa [1–4] . The Meningitis Vaccine Project, a partnership between the World Health Organization (WHO) and the Program for Appropriate Technology in Health (PATH, Seattle, WA, USA) with core funding from the Bill & Melinda Gates Foundation, was created in 2001 with the goal of eliminating meningococcal epidemics in sub-Saharan Africa through the development, testing, licensure, and widespread use of conjugate meningococcal vaccines [5,6] .

Keywords

Clinical studies
Conjugate vaccine
Meningitis epidemics
Meningococcal group A
Phase I

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.vaccine.2007.04.050

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Kshirsagar, N., Mur, N., Thatte, U., Gogtay, N., Viviani, S., Préziosi, M. P., Elie, C., Findlow, H., Carlone, G., Borrow, R., Parulekar, V., Plikaytis, B., Kulkarni, P., Imbault, N., & LaForce, F. M. (2007). Safety, immunogenicity, and antibody persistence of a new meningococcal group A conjugate vaccine in healthy Indian adults. Vaccine, 25(SUPPL. 1), A101-A107. https://doi.org/10.1016/j.vaccine.2007.04.050

@article{3830715d71a24fb2905d455214b43fca,

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 Meningoccoccal Polysaccharide Vaccine A + C{\texttrademark}, Pasteur, Lyon, France (Group 2), and 25 received the Tetanus Toxoid Vaccine Adsorbed{\texttrademark}, 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.",

keywords = "Clinical studies, Conjugate vaccine, Meningitis epidemics, Meningococcal group A, Phase I",

author = "Nilima Kshirsagar and Naidu Mur and Urmila Thatte and Nithya Gogtay and Simonetta Viviani and Pr{\'e}ziosi, {Marie Pierre} and Cheryl Elie and Helen Findlow and George Carlone and Raymond Borrow and Varsha Parulekar and Brian Plikaytis and Prasad Kulkarni and Nathalie Imbault and LaForce, {F. Marc}",

note = "Funding Information: This study was funded by the Meningitis Vaccine Project ( http://www.meningvax.org ). Funding Information: Epidemics of group A Neisseria meningitidis are a major unresolved public health problem in sub-Saharan Africa [1–4] . The Meningitis Vaccine Project, a partnership between the World Health Organization (WHO) and the Program for Appropriate Technology in Health (PATH, Seattle, WA, USA) with core funding from the Bill & Melinda Gates Foundation, was created in 2001 with the goal of eliminating meningococcal epidemics in sub-Saharan Africa through the development, testing, licensure, and widespread use of conjugate meningococcal vaccines [5,6] . ",

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doi = "10.1016/j.vaccine.2007.04.050",

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Kshirsagar, N, Mur, N, Thatte, U, Gogtay, N, Viviani, S, Préziosi, MP, Elie, C, Findlow, H, Carlone, G, Borrow, R, Parulekar, V, Plikaytis, B, Kulkarni, P, Imbault, N & LaForce, FM 2007, 'Safety, immunogenicity, and antibody persistence of a new meningococcal group A conjugate vaccine in healthy Indian adults', Vaccine, vol. 25, no. SUPPL. 1, pp. A101-A107. https://doi.org/10.1016/j.vaccine.2007.04.050

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T1 - Safety, immunogenicity, and antibody persistence of a new meningococcal group A conjugate vaccine in healthy Indian adults

AU - Kshirsagar, Nilima

AU - Mur, Naidu

AU - Thatte, Urmila

AU - Gogtay, Nithya

AU - Viviani, Simonetta

AU - Préziosi, Marie Pierre

AU - Elie, Cheryl

AU - Findlow, Helen

AU - Carlone, George

AU - Borrow, Raymond

AU - Parulekar, Varsha

AU - Plikaytis, Brian

AU - Kulkarni, Prasad

AU - Imbault, Nathalie

AU - LaForce, F. Marc

N1 - Funding Information: This study was funded by the Meningitis Vaccine Project ( http://www.meningvax.org ). Funding Information: Epidemics of group A Neisseria meningitidis are a major unresolved public health problem in sub-Saharan Africa [1–4] . The Meningitis Vaccine Project, a partnership between the World Health Organization (WHO) and the Program for Appropriate Technology in Health (PATH, Seattle, WA, USA) with core funding from the Bill & Melinda Gates Foundation, was created in 2001 with the goal of eliminating meningococcal epidemics in sub-Saharan Africa through the development, testing, licensure, and widespread use of conjugate meningococcal vaccines [5,6] .

PY - 2007/9/3

Y1 - 2007/9/3

N2 - 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 Meningoccoccal 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.

AB - 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 Meningoccoccal 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.

KW - Clinical studies

KW - Conjugate vaccine

KW - Meningitis epidemics

KW - Meningococcal group A

KW - Phase I

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U2 - 10.1016/j.vaccine.2007.04.050

DO - 10.1016/j.vaccine.2007.04.050

M3 - Article

C2 - 17532101

AN - SCOPUS:34547655976

SN - 0264-410X

VL - 25

SP - A101-A107

JO - Vaccine

JF - Vaccine

IS - SUPPL. 1

ER -

Safety, immunogenicity, and antibody persistence of a new meningococcal group A conjugate vaccine in healthy Indian adults

Abstract

Bibliographical note

Keywords

UN SDGs

Access to Document

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