Safety of dengue vaccine (CYD-TDV) in Asia: a systematic review

Cover Page


Cite item

Full Text

Abstract

The use of the vaccine in Asia is still very much limited and remained controversial due to its safety, which has yet been properly assessed and evaluated. Hence, the objective of this review is to assess the safety of the CYD-TDV dengue vaccine of the efficacy trials conducted in Asia. A total of 309 related articles were generated from the electronic database search using relevant keywords and only four of the articles were selected for the final review process. The seroprevalence at baseline of the participants involved in the studies was between 50 percent and 80 percent. In terms of the safety of the CYD-TDV vaccine, injection site reaction (pain, swelling, erythema) recorded a relative risk (RR) at 95% CI of (0.46—1.76) and systemic reactions (fever, headache, myalgia) also with RR at 95% CI of (0.89—1.81) were detected among the participants. Among the four studies reviewed, three studies reported some severe adverse effect experienced by the participants with RR at 95% CI of (0.92—2.11). In terms of the immunogenicity, high GMT values were reported for DENV-2 at 67.8 (95%CI of 64.8-70.8), DENV-3 at 73.1 (95% CI of 69.9-76.3) and DENV-4 at 65 (95%CI of 62-67.9) where even though lower values were reported it is consistent with other published studies on the immunogenicity of the CYD-TDV against the DENV serotypes. This review showed that the CYD-TDV can be considered for use in Asia, but with several conditions and following current safety recommendations.

About the authors

W. R. Wan Ismail

National University of Malaysia

Email: drwanros@yahoo.com

Doctor of Public Health, Department of Community Health, National University of Malaysia.

Kuala Lumpur.

Malaysia

M. Sh. Abdul Majid

National University of Malaysia

Email: uranium1987@gmail.com

Doctor of Public Health, Department of Community Health, National University of Malaysia.

Kuala Lumpur.

Malaysia

H. Y. Li

National University of Malaysia

Email: amanda.hua53@gmail.com

Master of Community Health Science, Department of Community Health, National University of Malaysia.

Kuala Lumpur.

Malaysia

M. F. Madrim

Universiti Malaysia Sabah

Email: faizalmadrim@gmail.com

Doctor of Public Health, Lecturer, Department of Community and Family Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah.

Kota Kinabalu.

Malaysia

S.Sh. S. Abdul Rahim

Universiti Malaysia Sabah

Email: syedsharizman@ums.edu.my

Doctor of Public Health, Head of the Department of Community and Family Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah.

Kota Kinabalu.

Malaysia

M. S. Jeffree

Universiti Malaysia Sabah

Email: saffree@ums.edu.my

Master of Community Medicine, Professor, Department of Community and Family Medicine, Dean of the Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah.

Kota Kinabalu.

Malaysia

Z. I. Azhar

Universiti Teknologi MARA

Email: drzahir@uitm.edu.my

Doctor of Public Health, Lecturer, Department of Public Health Medicine, Faculty of Medicine, Universiti Teknologi MARA.

Shah Alam.

Malaysia

H. F. Ghazi

College of Nursing, Al-Bayan University

Email: dr.hasanainhabasha@gmail.com

Associate Professor, College of Nursing, Al-Bayan University.

Baghdad.

Iraq

M. R. Hassan

National University of Malaysia

Author for correspondence.
Email: rohaizat@ppukm.ukm.edu.my

Mohd Rohaizat Hassan - PhD, Head of the Department of Community Health, National University of Malaysia.

Jalan Yaacob Latiff, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur.

Malaysia

References

  1. Aguiar M., Stollenwerk N., Halstead S.B. The Impact of the newly licensed dengue vaccine in endemic countries. PLoS Negl. Trop. Dis., 2016, vol. 10, no. 12: e0005179. doi: 10.1371/journal.pntd.0005179
  2. Bhatt S., Gething P.W., Brady O.J., Messina J.P., Farlow A.W., Moyes C.L., Drake J.M., Brownstein J.S., Hoen A.G., Sankoh O., Myers M.F., George D.B., Jaenisch T., Wint G.R., Simmons C.P., Scott T.W., Farrar J.J., Hay S.I. The global distribution and burden of dengue. Nature, 2013, vol. 496, no. 7446, pp. 504—507. doi: 10.1038/nature12060
  3. Capeding M.R., Laot T.M., Boaz M., Wartel T.A., Crevat D. Immunogenicity and safety of a tetravalent dengue vaccine during a five-year follow-up period. Trials Vaccinol., 2015, vol. 4, pp. 19—23. doi: 10.1016/j.trivac.2015.03.002
  4. Capeding M.R., Tran N.H., Hadinegoro S.R., Ismail H.I., Chotpitayasunondh T., Chua M.N., Luong C.Q., Rusmil K., Wirawan D.N., Nallusamy R., Pitisuttithum P., Thisyakorn U., Yoon I.K., van der Vliet D., Langevin E., Laot T., Hutagalung Y., Frago C., Boaz M., Wartel T.A., Tornieporth N.G., Saville M., Bouckenooghe A.; CYD14 Study Group. Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial. Lancet, 2014, vol. 384, no. 9951,pp. 1358-1365. doi: 10.1016/S0140--6736(14)61060--6
  5. Coudeville L., Baurin N., Vergu E. Estimation of parameters related to vaccine efficacy and dengue transmission from two large phase III studies. Vaccine, 2016, vol. 34, no. 50, pp. 6417-6425. doi: 10.1016/j.vaccine.2015.11.023
  6. Crevat D., Brion J.D., Gailhardou S., Laot T.M., Capeding M.R. First experience of concomitant vaccination against dengue and MMR in toddlers. Pediatr. Infect. Dis. J., 2015, vol. 34, no. 8, pp. 884-892. doi: 10.1097/INF.0000000000000752
  7. Da Costa V.G., Marques-Silva A.C., Floriano V.G., Moreli M.L. Safety, immunogenicity and efficacy of a recombinant tetravalent dengue vaccine: a meta-analysis of randomized trials. Vaccine, 2014, vol. 32, no. 39, pp. 4885-4892. doi: 10.1016/j.vaccine.2014.07.008
  8. Guy B., Jackson N. Dengue vaccine: hypotheses to understand CYD-TDV-induced protection. Nat. Rev. Microbiol., 2015, vol. 14, pp. 45-54. doi: 10.1038/nrmicro.2015.2
  9. Hss A.S., Koh M.T., Tan K.K., Chan L.G., Zhou L., Bouckenooghe A., Crevat D., Hutagalung Y. Safety and immunogenicity of a tetravalent dengue vaccine in healthy children aged 2—11 years in Malaysia: a randomized, placebo-controlled, Phase III study. Vaccine, 2013, vol. 31, no. 49, pp. 5814-5821. doi: 10.1016/j.vaccine.2013.10.013
  10. Leo Y.S., Wilder-Smith A., Archuleta S., Shek L.P., Chong C-Y, Leong H.N., Low C.Y., Oh M.-L.H., Bouckenooghe A., Wartel T.A., Crevat D. Immunogenicity and safety of recombinant tetravalent dengue vaccine (CYD-TDV) in individuals aged 2—45 y: Phase II randomized controlled trial in Singapore. Hum. Vaccin. Immunother., 2012, vol. 8, no. 9, pp. 1259-1271. doi: 10.4161/hv.21224
  11. Malisheni M., Khaiboullina S.F., Rizvanov A.A., Takah N., Murewanhema G., Bates M. Clinical efficacy, safety, and immunogenicity of a live attenuated tetravalent dengue vaccine (CYD-TDV) in children: a systematic review with meta-analysis. Front. Immunol., 2017, vol. 8: 863. doi: 10.3389/fimmu.2017.00863
  12. Mustafa M.S., Rasotgi V., Jain S., Gupta V. Discovery of fifth serotype of dengue virus (DENV-5): a new public health dilemma in dengue control. Med. J. Armed Forces India, 2015, vol. 71, no. 1, pp. 67—70. doi: 10.1016/j.mjafi.2014.09.011
  13. Rainwater-Lovett K., Rodriguez-Barraquer I., Cummings D.A.T., Lessler J. Variation in dengue virus plaque reduction neutralization testing: systematic review and pooled analysis. BMC Infect. Dis., 2012, vol. 12, no. 1: 233. doi: 10.1186/1471-2334-12-233
  14. ReviewManager (RevMan). Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014. URL: https://training.cochrane.org/online-learning/core-software-cochrane-reviews/revman
  15. Tang K.F., Ooi E.E. Diagnosis of dengue: an update. Expert Rev. Anti Infect. Ther, 2012, vol. 10, no. 8, pp. 895—907. doi: 10.1586/eri.12.76
  16. Thomas S.J., Nisalak A., Anderson K.B., Libraty D.H., Kalayanarooj S., Vaughn D.W., Putnak R., Gibbons R.V., Jarman R., Endy T.P. Dengue plaque reduction neutralization test (PRNT) in primary and secondary dengue virus infections: how alterations in assay conditions impact performance. Am. J. Trop. Med. Hyg, 2009, vol. 81, no. 5, pp. 825—833. doi: 10.4269/ajt-mh.2009.08-0625
  17. Tran N.H., Luong C.Q., Vu T.Q.H., Forrat R., Lang J., Vu Q.D., Bouckenooghe A., Wartel T.A. Safety and immunogenicity of recombinant, live attenuated tetravalent dengue vaccine (CYD-TDV) in healthy vietnamese adults and children. J. Vaccines Vaccin., 2012, vol. 3, iss. 7: 1000162. doi: 10.4172/2157-7560.1000162
  18. WHO. Dengue: guidelines for diagnosis, treatment, prevention and control: new edition. Geneva: WHO, 2009. 147p.
  19. WHO. Revised SAGE recommendation on use of dengue vaccine. Geneva: WHO, 2018. URL: http://www.who.int/immunization/diseases/dengue/revised_SAGE_recommendations_dengue_vaccines_apr2018/en

Supplementary files

Supplementary Files
Action
1. JATS XML
Download

Copyright (c) 2020 Wan Ismail W.R., Abdul Majid M.S., Li H.Y., Madrim M.F., Abdul Rahim S.S., Jeffree M.S., Azhar Z.I., Ghazi H.F., Hassan M.R.

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
СМИ зарегистрировано Федеральной службой по надзору в сфере связи, информационных технологий и массовых коммуникаций (Роскомнадзор).
Регистрационный номер и дата принятия решения о регистрации СМИ: серия ПИ № ФС 77 - 64788 от 02.02.2016.


This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies