Effect of Dengue Serostatus on Dengue Vaccine Safety and Efficacy

Sridhar, Saranya; Luedtke, Alexander R.; Langevin, Edith; Zhu, Ming; Bonaparte, Matthew; Machabert, Tifany; Savarino, Stephen J.; Zambrano, Betzana; Moureau, Annick; Khromava, Alena; Moodie, Zoe; Westling, Ted; Mascareñas, César; Frago, Carina; Cortés, Margarita; Chansinghakul, Danaya; Noriega, Fernando; Bouckenooghe, Alain; Chen, Josh; Ng, Su-Peing; Gilbert, Peter B.; Gurunathan, Sanjay; DiazGranados, Carlos A.

doi:10.1056/nejmoa1800820

Cited by 620 publications

(568 citation statements)

References 21 publications

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“…Since the isolation of DENV in 1943, the development of an effective vaccine that provides balanced, long‐lasting immunity has been challenging. This is partly due to the complexity of dengue epidemiology, population immunity, and the interplay between viral pathogenesis and host immunological mechanisms . Like other successful flavivirus vaccines against yellow fever and Japanese encephalitis, the majority of dengue vaccine candidates either approved for limited license or in Phase III trials are LAVs .…”

Section: Introductionmentioning

confidence: 99%

Microneedle‐based intradermal delivery of stabilized dengue virus

Turvey

Uppu

Sharif

et al. 2019

Bioengineering & Transla Med

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Current live‐attenuated dengue vaccines require strict cold chain storage. Methods to preserve dengue virus (DENV) viability, which enable vaccines to be transported and administered at ambient temperatures, will be decisive towards the implementation of affordable global vaccination schemes with broad immunization coverage in resource‐limited areas. We have developed a microneedle (MN)‐based vaccine platform for the stabilization and intradermal delivery of live DENV from minimally invasive skin patches. Dengue virus‐stabilized microneedle arrays (VSMN) were fabricated using saccharide‐based formulation of virus and could be stored dry at ambient temperature up to 3 weeks with maintained virus viability. Following intradermal vaccination, VSMN‐delivered DENV was shown to elicit strong neutralizing antibody responses and protection from viral challenge, comparable to that of the conventional liquid vaccine administered subcutaneously. This work supports the potential for MN‐based dengue vaccine technology and the progression towards cold chain‐independence. Dengue virus can be stabilized using saccharide‐based formulations and coated on microneedle array vaccine patches for storage in dry state with preserved viability at ambient temperature (VSMN; virus‐stabilized microneedle arrays).

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Section: Introductionmentioning

confidence: 99%

Microneedle‐based intradermal delivery of stabilized dengue virus

Turvey

Uppu

Sharif

et al. 2019

Bioengineering & Transla Med

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“…These studies revealed that vaccine performance was indeed affected by serostatus, with vaccine efficacy being significantly higher in seropositives than seronegatives. Furthermore, an increased risk of hospitalized, severe dengue was observed among seronegative vaccine recipients as compared to seronegative controls (Sridhar et al 2018). In light of this new evidence regarding vaccine-related ADE, WHO-SAGE issued updated recommendations on the use of CYD-TDV vaccine in April 2018 (Wilder-Smith et al 2019).…”

Section: Implications For Dengue Vaccinesmentioning

confidence: 99%

Antibody-Dependent Enhancement of Viral Infections

Kulkarni

2020

Dynamics of Immune Activation in Viral Diseases

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Antiviral antibodies constitute an important component of the host immune response against viral infections and serve to neutralize and reduce infectivity of the virus. However, these antibodies, intended to protect the host, may sometimes prove beneficial to the virus, by facilitating viral entry and replication in the target cell. This phenomenon, known as antibody-dependent enhancement (ADE) of infection, is a result of interaction of virus-antibody immune complexes with Fcγ and/or complement receptors on certain types of host cells and promotes viral entry into the host cells. The internalized immune complexes then modulate host immune response so as to enhance viral replication and aggravate disease severity. The possibility of induction of ADE remains a concern in the development and implementation of viral vaccines and immunotherapeutics.

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“…A recent study added to the growing safety concerns by demonstrating that in seronegative vaccine recipients the risk of hospitalisation and severe dengue was higher than in individuals who were seropositive at baseline regardless of age . In this study, all cases of virologically confirmed dengue were reassessed for hospitalisation and severe dengue by serostatus and age groups.…”

mentioning

confidence: 97%

“…The increased risk of more severe infection in seronegative vaccine recipients was observed up to 30 months after vaccination. In contrast, vaccine efficacy in all age groups was significantly higher in seropositive individuals (76%) compared with seronegative individuals (39%) . Based on these findings, the World Health Organization reconvened SAGE and in 2018 revised the recommendations for the use of CYD‐TDV (Box 1).…”

mentioning

confidence: 99%