Immunogenicity and safety of a new meningococcal A conjugate vaccine in Indian children aged 2-10 years: A Phase II/III double-blind randomized controlled trial

Siddhivinayak Hirve; Ashish Bavdekar; Anand Pandit; Sanjay Juvekar; Malini Patil; Marie Pierre Preziosi; Yuxiao Tang; Elisa Marchetti; Lionel Martellet; Helen Findlow; Cheryl Elie; Varsha Parulekar; Brian Plikaytis; Ray Borrow; George Carlone; Prasad S. Kulkarni; Akshay Goel; Karupothula Suresh; Suresh Beri; Subhash Kapre; Suresh Jadhav; Jean Marie Preaud; Simonetta Viviani; Marc F. LaForcec

doi:10.1016/j.vaccine.2012.08.004

Immunogenicity and safety of a new meningococcal A conjugate vaccine in Indian children aged 2-10 years: A Phase II/III double-blind randomized controlled trial

Siddhivinayak Hirve, Ashish Bavdekar, Anand Pandit, Sanjay Juvekar, Malini Patil, Marie Pierre Preziosi, Yuxiao Tang, Elisa Marchetti, Lionel Martellet, Helen Findlow, Cheryl Elie, Varsha Parulekar, Brian Plikaytis, Ray Borrow, George Carlone, Prasad S. Kulkarni, Akshay Goel, Karupothula Suresh, Suresh Beri, Subhash KapreSuresh Jadhav, Jean Marie Preaud, Simonetta Viviani, Marc F. LaForcec^*

^*Corresponding author for this work

Manchester Lab Vaccine Evaluation

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

27 Citations (Scopus)

Abstract

This study compares the immunogenicity and safety of a single dose of a new meningococcal A conjugate vaccine (PsA-TT, MenAfriVac™, Serum Institute of India Ltd., Pune) against the meningococcal group A component of a licensed quadrivalent meningococcal polysaccharide vaccine (PsACWY, Mencevax ACWY^®, GSK, Belgium) 28 days after vaccination in Indian children. This double-blind, randomized, controlled study included 340 Indian children aged 2-10 years enrolled from August to October 2007; 169 children received a dose of PsA-TT while 171 children received a dose of PsACWY. Intention-to-treat analysis showed that 95.2% of children in PsA-TT group had a ≥4-fold response in serum bactericidal titers (rSBA) 28 days post vaccination as compared to 78.2% in the PsACWY group. A significantly higher rSBA GMT (11,209, 95%CI 9708-12,942) was noted in the PsA-TT group when compared to PsACWY group (2838, 95%CI 2368-3401). Almost all children in both vaccine groups had a ≥4-fold response in group A-specific IgG concentration but the IgG GMC was significantly greater in the PsA-TT group (89.1μg/ml, 95%CI 75.5-105.0) when compared to the PsACWY group (15.3μg/ml, 95%CI 12.3-19.2). Local and systemic reactions during the 4 days after immunization were similar for both vaccine groups except for tenderness (30.2% in PsA-TT group vs 12.3% in PsACWY group). None of the adverse events or serious adverse events was related to the study vaccines. We conclude that MenAfriVac™ is well tolerated and significantly more immunogenic when compared to a licensed polysaccharide vaccine, in 2-to-10-year-old Indian children.

Original language	English
Pages (from-to)	6456-6460
Number of pages	5
Journal	Vaccine
Volume	30
Issue number	45
DOIs	https://doi.org/10.1016/j.vaccine.2012.08.004
Publication status	Published - 5 Oct 2012

Bibliographical note

Funding Information:
The authors gratefully acknowledge financial support from the Meningitis Vaccine Project ; the Serum Institute of India, Ltd. for vaccines, and technical support; DiagnoSearch for their help with pharmacovigilance, data management, and logistics; and the laboratories at CDC, Atlanta, GA, USA (Julie Chatt-Soroka and Jeffrey Martin), and the Health Protection Agency, Manchester, UK for ELISA and rSBA testing, respectively. The authors gratefully acknowledge the assistance of Nicole Basta who helped draft the initial manuscript. The study received support from the Health and Demographic Surveillance System, Vadu which is a member of the INDEPTH Network. Lastly, the authors express their gratitude to the children and their parents and the Vadu community as a whole for their support and participation in the study.

Keywords

Conjugate vaccine
Immunogenicity
Meningococcus
Safety
Serogroup A

UN SDGs

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

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10.1016/j.vaccine.2012.08.004

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Hirve, S., Bavdekar, A., Pandit, A., Juvekar, S., Patil, M., Preziosi, M. P., Tang, Y., Marchetti, E., Martellet, L., Findlow, H., Elie, C., Parulekar, V., Plikaytis, B., Borrow, R., Carlone, G., Kulkarni, P. S., Goel, A., Suresh, K., Beri, S., ... LaForcec, M. F. (2012). Immunogenicity and safety of a new meningococcal A conjugate vaccine in Indian children aged 2-10 years: A Phase II/III double-blind randomized controlled trial. Vaccine, 30(45), 6456-6460. https://doi.org/10.1016/j.vaccine.2012.08.004

@article{428cf9a00d944ddfa99a38f3c86dce3b,

title = "Immunogenicity and safety of a new meningococcal A conjugate vaccine in Indian children aged 2-10 years: A Phase II/III double-blind randomized controlled trial",

abstract = "This study compares the immunogenicity and safety of a single dose of a new meningococcal A conjugate vaccine (PsA-TT, MenAfriVac{\texttrademark}, Serum Institute of India Ltd., Pune) against the meningococcal group A component of a licensed quadrivalent meningococcal polysaccharide vaccine (PsACWY, Mencevax ACWY{\textregistered}, GSK, Belgium) 28 days after vaccination in Indian children. This double-blind, randomized, controlled study included 340 Indian children aged 2-10 years enrolled from August to October 2007; 169 children received a dose of PsA-TT while 171 children received a dose of PsACWY. Intention-to-treat analysis showed that 95.2\% of children in PsA-TT group had a ≥4-fold response in serum bactericidal titers (rSBA) 28 days post vaccination as compared to 78.2\% in the PsACWY group. A significantly higher rSBA GMT (11,209, 95\%CI 9708-12,942) was noted in the PsA-TT group when compared to PsACWY group (2838, 95\%CI 2368-3401). Almost all children in both vaccine groups had a ≥4-fold response in group A-specific IgG concentration but the IgG GMC was significantly greater in the PsA-TT group (89.1μg/ml, 95\%CI 75.5-105.0) when compared to the PsACWY group (15.3μg/ml, 95\%CI 12.3-19.2). Local and systemic reactions during the 4 days after immunization were similar for both vaccine groups except for tenderness (30.2\% in PsA-TT group vs 12.3\% in PsACWY group). None of the adverse events or serious adverse events was related to the study vaccines. We conclude that MenAfriVac{\texttrademark} is well tolerated and significantly more immunogenic when compared to a licensed polysaccharide vaccine, in 2-to-10-year-old Indian children.",

keywords = "Conjugate vaccine, Immunogenicity, Meningococcus, Safety, Serogroup A",

author = "Siddhivinayak Hirve and Ashish Bavdekar and Anand Pandit and Sanjay Juvekar and Malini Patil and Preziosi, \{Marie Pierre\} and Yuxiao Tang and Elisa Marchetti and Lionel Martellet and Helen Findlow and Cheryl Elie and Varsha Parulekar and Brian Plikaytis and Ray Borrow and George Carlone and Kulkarni, \{Prasad S.\} and Akshay Goel and Karupothula Suresh and Suresh Beri and Subhash Kapre and Suresh Jadhav and Preaud, \{Jean Marie\} and Simonetta Viviani and LaForcec, \{Marc F.\}",

note = "Funding Information: The authors gratefully acknowledge financial support from the Meningitis Vaccine Project ; the Serum Institute of India, Ltd. for vaccines, and technical support; DiagnoSearch for their help with pharmacovigilance, data management, and logistics; and the laboratories at CDC, Atlanta, GA, USA (Julie Chatt-Soroka and Jeffrey Martin), and the Health Protection Agency, Manchester, UK for ELISA and rSBA testing, respectively. The authors gratefully acknowledge the assistance of Nicole Basta who helped draft the initial manuscript. The study received support from the Health and Demographic Surveillance System, Vadu which is a member of the INDEPTH Network. Lastly, the authors express their gratitude to the children and their parents and the Vadu community as a whole for their support and participation in the study. ",

year = "2012",

month = oct,

day = "5",

doi = "10.1016/j.vaccine.2012.08.004",

language = "English",

volume = "30",

pages = "6456--6460",

journal = "Vaccine",

issn = "0264-410X",

publisher = "Elsevier Ltd.",

number = "45",

}

Hirve, S, Bavdekar, A, Pandit, A, Juvekar, S, Patil, M, Preziosi, MP, Tang, Y, Marchetti, E, Martellet, L, Findlow, H, Elie, C, Parulekar, V, Plikaytis, B, Borrow, R, Carlone, G, Kulkarni, PS, Goel, A, Suresh, K, Beri, S, Kapre, S, Jadhav, S, Preaud, JM, Viviani, S & LaForcec, MF 2012, 'Immunogenicity and safety of a new meningococcal A conjugate vaccine in Indian children aged 2-10 years: A Phase II/III double-blind randomized controlled trial', Vaccine, vol. 30, no. 45, pp. 6456-6460. https://doi.org/10.1016/j.vaccine.2012.08.004

TY - JOUR

T1 - Immunogenicity and safety of a new meningococcal A conjugate vaccine in Indian children aged 2-10 years

T2 - A Phase II/III double-blind randomized controlled trial

AU - Hirve, Siddhivinayak

AU - Bavdekar, Ashish

AU - Pandit, Anand

AU - Juvekar, Sanjay

AU - Patil, Malini

AU - Preziosi, Marie Pierre

AU - Tang, Yuxiao

AU - Marchetti, Elisa

AU - Martellet, Lionel

AU - Findlow, Helen

AU - Elie, Cheryl

AU - Parulekar, Varsha

AU - Plikaytis, Brian

AU - Borrow, Ray

AU - Carlone, George

AU - Kulkarni, Prasad S.

AU - Goel, Akshay

AU - Suresh, Karupothula

AU - Beri, Suresh

AU - Kapre, Subhash

AU - Jadhav, Suresh

AU - Preaud, Jean Marie

AU - Viviani, Simonetta

AU - LaForcec, Marc F.

N1 - Funding Information: The authors gratefully acknowledge financial support from the Meningitis Vaccine Project ; the Serum Institute of India, Ltd. for vaccines, and technical support; DiagnoSearch for their help with pharmacovigilance, data management, and logistics; and the laboratories at CDC, Atlanta, GA, USA (Julie Chatt-Soroka and Jeffrey Martin), and the Health Protection Agency, Manchester, UK for ELISA and rSBA testing, respectively. The authors gratefully acknowledge the assistance of Nicole Basta who helped draft the initial manuscript. The study received support from the Health and Demographic Surveillance System, Vadu which is a member of the INDEPTH Network. Lastly, the authors express their gratitude to the children and their parents and the Vadu community as a whole for their support and participation in the study.

PY - 2012/10/5

Y1 - 2012/10/5

N2 - This study compares the immunogenicity and safety of a single dose of a new meningococcal A conjugate vaccine (PsA-TT, MenAfriVac™, Serum Institute of India Ltd., Pune) against the meningococcal group A component of a licensed quadrivalent meningococcal polysaccharide vaccine (PsACWY, Mencevax ACWY®, GSK, Belgium) 28 days after vaccination in Indian children. This double-blind, randomized, controlled study included 340 Indian children aged 2-10 years enrolled from August to October 2007; 169 children received a dose of PsA-TT while 171 children received a dose of PsACWY. Intention-to-treat analysis showed that 95.2% of children in PsA-TT group had a ≥4-fold response in serum bactericidal titers (rSBA) 28 days post vaccination as compared to 78.2% in the PsACWY group. A significantly higher rSBA GMT (11,209, 95%CI 9708-12,942) was noted in the PsA-TT group when compared to PsACWY group (2838, 95%CI 2368-3401). Almost all children in both vaccine groups had a ≥4-fold response in group A-specific IgG concentration but the IgG GMC was significantly greater in the PsA-TT group (89.1μg/ml, 95%CI 75.5-105.0) when compared to the PsACWY group (15.3μg/ml, 95%CI 12.3-19.2). Local and systemic reactions during the 4 days after immunization were similar for both vaccine groups except for tenderness (30.2% in PsA-TT group vs 12.3% in PsACWY group). None of the adverse events or serious adverse events was related to the study vaccines. We conclude that MenAfriVac™ is well tolerated and significantly more immunogenic when compared to a licensed polysaccharide vaccine, in 2-to-10-year-old Indian children.

AB - This study compares the immunogenicity and safety of a single dose of a new meningococcal A conjugate vaccine (PsA-TT, MenAfriVac™, Serum Institute of India Ltd., Pune) against the meningococcal group A component of a licensed quadrivalent meningococcal polysaccharide vaccine (PsACWY, Mencevax ACWY®, GSK, Belgium) 28 days after vaccination in Indian children. This double-blind, randomized, controlled study included 340 Indian children aged 2-10 years enrolled from August to October 2007; 169 children received a dose of PsA-TT while 171 children received a dose of PsACWY. Intention-to-treat analysis showed that 95.2% of children in PsA-TT group had a ≥4-fold response in serum bactericidal titers (rSBA) 28 days post vaccination as compared to 78.2% in the PsACWY group. A significantly higher rSBA GMT (11,209, 95%CI 9708-12,942) was noted in the PsA-TT group when compared to PsACWY group (2838, 95%CI 2368-3401). Almost all children in both vaccine groups had a ≥4-fold response in group A-specific IgG concentration but the IgG GMC was significantly greater in the PsA-TT group (89.1μg/ml, 95%CI 75.5-105.0) when compared to the PsACWY group (15.3μg/ml, 95%CI 12.3-19.2). Local and systemic reactions during the 4 days after immunization were similar for both vaccine groups except for tenderness (30.2% in PsA-TT group vs 12.3% in PsACWY group). None of the adverse events or serious adverse events was related to the study vaccines. We conclude that MenAfriVac™ is well tolerated and significantly more immunogenic when compared to a licensed polysaccharide vaccine, in 2-to-10-year-old Indian children.

KW - Conjugate vaccine

KW - Immunogenicity

KW - Meningococcus

KW - Safety

KW - Serogroup A

UR - https://www.scopus.com/pages/publications/84866487460

U2 - 10.1016/j.vaccine.2012.08.004

DO - 10.1016/j.vaccine.2012.08.004

M3 - Article

C2 - 22898557

AN - SCOPUS:84866487460

SN - 0264-410X

VL - 30

SP - 6456

EP - 6460

JO - Vaccine

JF - Vaccine

IS - 45

ER -

Immunogenicity and safety of a new meningococcal A conjugate vaccine in Indian children aged 2-10 years: A Phase II/III double-blind randomized controlled trial

Abstract

Bibliographical note

Keywords

UN SDGs

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