Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2–17 years: a randomised, placebo-controlled, phase 2 trial

Tricou, Vianney; Sáez-Llorens, Xavier; Yu, Delia; Rivera, Luis; Jimeno, J.; Ballesteros, Ana Cecilia Villarreal; Dato, Epiphany; Suman, Onix Saldaña de; Montenegro, Nathali; DeAntonio, Rodrigo; Mazara, Sonia; Vargas, María José; Mendoza, Debbie; Rauscher, Martina; Brose, Manja; Lefevre, Inge; Tuboi, Suely; Borkowski, Astrid; Wallace, Derek

doi:10.1016/s0140-6736(20)30556-0

Cited by 73 publications

(78 citation statements)

References 20 publications

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“…The silent majority carriers in the incubation period were found to be major sources of dengue virus transmission (Ferguson et al, 2018). What's more, live attenuated vaccine (CYD-TDV) has been used and candidate dengue vaccinations are currently proven to be effective in endemic populations (Biswal et al, 2019;Biswal et al, 2020;Deng et al, 2020;Tricou et al, 2020).…”

Section: Discussionmentioning

confidence: 99%

Emergence and Autochthonous Transmission of Dengue Virus Type I in a Low-Epidemic Region in Southeast China

Zhang

Chen

Wang³

et al. 2021

Front. Cell. Infect. Microbiol.

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BackgroundDengue fever is a mosquito-borne febrile illness. Southeast Asia experienced severe dengue outbreaks in 2019, and over 1000 cases had been reported in Jiangxi, a previously known low-epidemic region in China. However, the emergence of a dengue virus epidemic in a non-epidemic region remains unclear.MethodsWe enrolled 154 dengue fever patients from four hospitals in Jiangxi, from April 2019 to September 2019. Real-time PCR, NS1 antigen rapid test, and IgM, IgG tests were performed, and 14 samples were outsourced to be sequenced metagenomically.ResultsAmong the 154 cases, 42 were identified as imported and most of them returned from Cambodia. A total of 113 blood samples were obtained and 106 were identified as DENV-1, two as DENV-2, and five were negative through RT-PCR. All DENV-1 strains sequenced in this study were all classified to one cluster and owned a high similarity with a Cambodia strain isolated in 2019. The evolutionary relationships of amino acid were consistent with that of nucleotide genome result. The sequence-based findings of Jiangxi strains were consistent with epidemiological investigation.ConclusionEpidemiological analysis demonstrated that the emergence of dengue cases led to autochthonous transmission in several cities in Jiangxi, a low-epidemic region before. This study emphasized future prevention and control of dengue fever in both epidemic and non-epidemic regions.

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Section: Discussionmentioning

confidence: 99%

Emergence and Autochthonous Transmission of Dengue Virus Type I in a Low-Epidemic Region in Southeast China

Zhang

Chen

Wang³

et al. 2021

Front. Cell. Infect. Microbiol.

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“…Several unique factors, associated with the biology, and pathogenesis of dengue, taken together with lessons of the Dengvaxia experience, necessitates exploring alternate dengue vaccine development options. There are additional whole virus-based dengue vaccines in advance stages of clinical trials (Clinicaltrials.gov, 2020;Tricou et al, 2020). Moreover, a few recombinant dengue vaccine candidates are also at various stages of development (Vannice et al, 2015;Swaminathan and Khanna, 2019;Deng et al, 2020).…”

Section: Introductionmentioning

confidence: 99%

Antibody-Dependent Enhancement: A Challenge for Developing a Safe Dengue Vaccine

Shukla

Ramasamy

Shanmugam

et al. 2020

Front. Cell. Infect. Microbiol.

139

113

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“…In particular, the live attenuated yellow fever vaccine that has been in use since 1938 is considered a gold standard as a safe and effective antiviral vaccine 12 . Live attenuated vaccines against DENV have also demonstrated good attenuation during clinical trials [13][14][15] . Live attenuated vaccines are highly immunogenic compared to inactivated vaccines 12 .…”

Section: Introductionmentioning

confidence: 99%

“…However, one major concern is that live vaccines that look promising during initial preclinical studies may show inadequate attenuation once they reach human clinical trials 16 . One way of addressing this risk is to repurpose a clinically validated vaccine strain to serve as a viral backbone for a chimeric virus [9][10][11][13][14][15]17,18 . Such a chimera would express the attenuated replication machinery of the vaccine strain, whilst also expressing the major structural antigens of the target virus.…”

Section: Introductionmentioning

confidence: 99%

“…Such a chimera would express the attenuated replication machinery of the vaccine strain, whilst also expressing the major structural antigens of the target virus. This strategy has been used in the development of several live attenuated tetravalent dengue vaccines, with the Sanofi-Pasteur, Takeda, and NIH dengue vaccines all containing at least one chimeric virus [13][14][15]17,18 . In particular, the Takeda TAK-003 (or DENVax) dengue vaccine that has recently completed phase II and III clinical trials contains four component viruses, one of which is the DENV2-PDK-53 vaccine strain that was developed by Mahidol University, Thailand 9,10,13,14,18,19 .…”

Section: Introductionmentioning

confidence: 99%

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A single-dose live attenuated chimeric vaccine candidate against Zika virus

et al. 2021

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The mosquito-borne Zika virus is an emerging pathogen from the Flavivirus genus for which there are no approved antivirals or vaccines. Using the clinically validated PDK-53 dengue virus vaccine strain as a backbone, we created a chimeric dengue/Zika virus, VacDZ, as a live attenuated vaccine candidate against Zika virus. VacDZ demonstrates key markers of attenuation: small plaque phenotype, temperature sensitivity, attenuation of neurovirulence in suckling mice, and attenuation of pathogenicity in interferon deficient adult AG129 mice. VacDZ may be administered as a traditional live virus vaccine, or as a DNA-launched vaccine that produces live VacDZ in vivo after delivery. Both vaccine formulations induce a protective immune response against Zika virus in AG129 mice, which includes neutralising antibodies and a strong Th1 response. This study demonstrates that VacDZ is a safe and effective vaccine candidate against Zika virus.

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Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2–17 years: a randomised, placebo-controlled, phase 2 trial

Cited by 73 publications

References 20 publications

Emergence and Autochthonous Transmission of Dengue Virus Type I in a Low-Epidemic Region in Southeast China

Emergence and Autochthonous Transmission of Dengue Virus Type I in a Low-Epidemic Region in Southeast China

Antibody-Dependent Enhancement: A Challenge for Developing a Safe Dengue Vaccine

A single-dose live attenuated chimeric vaccine candidate against Zika virus

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