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A JAPANESE ENCEPHALITIS VACCINE FROM INDIA INDUCES DURABLE AND CROSS-PROTECTIVE IMMUNITY AGAINST TEMPORALLY AND SPATIALLY WIDE-RANGING GLOBAL FIELD STRAINS

Friday, 23rd of January 2015

A JAPANESE ENCEPHALITIS VACCINE FROM INDIA INDUCES DURABLE AND CROSS-PROTECTIVE IMMUNITY AGAINST TEMPORALLY AND SPATIALLY WIDE-RANGING GLOBAL FIELD STRAINS

1. Anit Singh1,
2. Monjori Mitra2,
3. G. Sampath3,
4. P. Venugopal4,
5. J. Venkateswara Rao5,
6. B. Krishnamurthy6,
7. Mukesh Kumar Gupta7,
8. S. Sri Krishna8,
9. B. Sudhakar9,
10. N. Bhuvaneswara Rao10,
11. Yashpal Kaushik1,
12. K. Gopinathan1,
13. Nagendra R. Hegde11,
14. Milind M. Gore12,
15. V. Krishna Mohan1 and
16. Krishna M. Ella1

+ Author Affiliations

1. ¹Bharat Biotech International Limited, Genome Valley, Turkapally, Shameerpet Mandal, Hyderabad - 500078, India
2. ²Institute of Child Health, Park Circus, Ballygunge, Kolkata - 700017, India
3. ³Institute of Preventive Medicine, Narayanaguda, Hyderabad - 500029, India
4. ⁴King George Hospital, Maharani Peta, Visakhapatnam - 530002, India
5. ⁵Gandhi Medical College, Padmarao Nagar, Secunderabad - 500020, India
6. ⁶Mysore Medical College, Sayyaji Rao Road, Yadavagiri, Mysore - 570001, India
7. ⁷Mahatma Gandhi Medical College, Sitapur Industrial Area, Sitapur, Jaipur - 302022, India
8. ⁸Mahavir Hospital and Research Centre, African Cavalry Guards, Masab Tank, Hyderabad - 500004, India
9. ⁹Priya Childrens Hospital, New P&T Colony, Patamata, Vijayavada - 520010, India
10. ¹⁰Sri Sreenivasa Childrens Hospital, Suryaraopet, Vijayavada - 520002, India
11. ¹¹Ella Foundation, Genome Valley, Turkapally, Shameerpet Mandal, Hyderabad - 500078, India
12. ¹²National Institute of Virology, Gorakhpur Unit, Baba Raghav Das Medical College Campus, Gorakhpur - 273013, India

1. Corresponding author: Nagendra R. Hegde, Ella Foundation, Genome Valley, Turkapally, Shameerpet Mandal, Hyderabad – 500078, India, Tel: +91-40-2348-0570, Email: hegden@ellafoundation.org

Abstract below; full text is available to JID subscribers.

Background. Japanese encephalitis (JE) is a vaccine-preventable acute disease. We report the results of a Phase II/III trial for JENVAC, a Vero cell-derived vaccine developed using an Indian strain of JE virus (JEV).

Methods. JENVAC was administered in two doses 28 days apart, and immunogenicity was compared to a single dose of SA-14-14-2, the only approved vaccine and regimen at the time in India (Clinical Trial Registry - India; CTRI/2011/07/001855; http://www.ctri.nic.in).

Results. After both the doses, seroconversion (SRC) and seroprotection (SRP) were >90% for JENVAC. For SA-14-14-2, SRC and SRP were 57.69% and 77.56% at d28, and 39.74% and 60.26% at d56, respectively. The GMTs at d28 and d56 were 145.04 and 460.53 for JENVAC, and 38.56 and 25.29 for SA-14-14-2, respectively. With a single dose of JENVAC, SRP titers lasted at least 12 months in >80% of the subjects. Following two doses, 61.17% retained SRP titers at 24 months, and immunogenicity criteria were higher than that for SA-14-14-2 at each of 12, 18 and 24 months. Sera from JENVAC subjects neutralized equally well JEV strains of genotypes I, II, III and IV. Adverse events were not significantly different between the two vaccines.

Conclusions. JENVAC elicits long-lasting, broadly protective immunity.

• Received September 30, 2014.
• Revision received December 29, 2014.
• Accepted January 6, 2015.

• © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.