Lot-to-lot consistency of a tetravalent dengue vaccine in healthy adults in Australia: A randomised study

Torresi, Joseph; Heron, Leon; Qiao, Ming; Marjason, Joanne; Chambonneau, Laurent; Bouckenooghe, Alain; Boaz, Mark; Vliet, Diane van der; Wallace, Derek; Hutagalung, Yanee; Nissen, Michael D.; Richmond, Peter

doi:10.1016/j.vaccine.2015.08.008

Cited by 22 publications

(14 citation statements)

References 23 publications

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“…Although there were differences in vaccine lots used across the studies, a formal analysis of lot-to-lot consistency was performed in the CYD17 study, which established biological and clinical equivalence between phase II and phase III vaccine lots (based on post-dose 3 GMTs). 10 …”

Section: Methodsmentioning

confidence: 99%

Integrated immunogenicity analysis of a tetravalent dengue vaccine up to 4 y after vaccination

Vigne

Dupuy

Richetin

et al. 2017

Human Vaccines & Immunotherapeutics

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Two large pivotal phase III studies demonstrated the efficacy of the tetravalent dengue vaccine (CYD-TDV; Dengvaxia®, Sanofi Pasteur) against all dengue serotypes. Here we present an unprecedented integrated summary of the immunogenicity of CYD-TDV to identify the parameters driving the neutralizing humoral immune response and evolution over time. We summarized the immunogenicity profiles of a 3-dose schedule of CYD-TDV administered 6 months apart across 10 phase II and 6 phase III trials undertaken in dengue endemic and non-endemic countries. Dengue neutralizing antibody titers in sera were determined at centralized laboratories using the 50% plaque reduction neutralization test (PRNT50) at baseline, 28 d after the third dose, and annually thereafter for up to 4 y after the third dose in some studies. CYD-TDV elicits neutralizing antibody responses against all 4 dengue serotypes; geometric mean titers (GMTs) increased from baseline to post-dose 3. GMTs were influenced by several parameters including age, baseline dengue seropositivity and region. In the 2 pivotal studies, GMTs decreased initially during the first 2 y post-dose 3 but appear to stabilize or slightly increase again in the third year. GMTs persisted 1.2–3.2-fold higher than baseline levels for up to 4 y post-dose 3 in other studies undertaken in dengue endemic countries. Our integrated analysis captures the fullness of the CYD-TDV immunogenicity profile across studies, age groups and regions; by presenting the available data in this way general trends and substantial outliers within each grouping can be easily identified. CYD-TDV elicits neutralizing antibody responses against all dengue serotypes, with differences by age and endemicity, which persist above baseline levels in endemic countries.

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Section: Methodsmentioning

confidence: 99%

Integrated immunogenicity analysis of a tetravalent dengue vaccine up to 4 y after vaccination

Vigne

Dupuy

Richetin

et al. 2017

Human Vaccines & Immunotherapeutics

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“…(DENV4) immunodominant vaccine [35]. This is further corroborated by studies on viremia levels where mainly viremia was only or mainly detected for serotype 4 [36,37]. The PRNT is an admixture of homotypic and heterotopic antibodies.…”

Section: Potential Explanations For the Excess Risk In Seronegative Vmentioning

confidence: 67%

The first licensed dengue vaccine: can it be used in travelers?

Wilder‐Smith

2019

Current Opinion in Infectious Diseases

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Purpose of review: The first dengue vaccine (Dengvaxia®) was endorsed by the European Medicine Agency and the US Food and Drug Administration. Given the excess risk of severe dengue in seronegative vaccinees, use is restricted to seropositive individuals. Dengvaxia confers high protection against severe dengue in seropositive vaccinees. Recent findings: With increasing global travel, the probability of travelers being seropositive increases. Such seropositive travelers may be at increased risk of severe dengue as a result of a second dengue infection during repeat travel. Nevertheless, the use of Dengvaxia in travelers requires a careful analysis of all the factors. Seropositive travelers only present a minority of all travelers. A validated rapid diagnostic test to screen for dengue serostatus is not yet available. Such a test should be highly specific to avoid inadvertent vaccination of seronegative individuals. The 3-dose regimen precludes the use in most travelers who tend to present at travel clinics less than 6 weeks prior to departure. Furthermore, questions about potential sub-optimal immunogenicity in seropositives in non-endemic settings, and the need and timing of boosters remain unanswered. Conclusions: Although there could potentially be substantial protection against severe dengue in seropositive travelers, Dengvaxia is far from an ideal travel vaccine.

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“…Sera samples from clinical trial subjects naive at baseline taken 28 days (postvaccine dose 3 [PD3]) after vaccination with CYD-TDV in a 0/6/12-month vaccination schedule were used from a study conducted in a nonendemic area for dengue ( , NCT01134263) [ 32 ]. To address responses against DENV2, these samples were selected with a broad range of PD3 DEN2 Vero PRNT titers.…”

Section: Methodsmentioning

confidence: 99%

Influence of FcγRIIa-Expressing Cells on the Assessment of Neutralizing and Enhancing Serum Antibodies Elicited by a Live-Attenuated Tetravalent Dengue Vaccine

Byers

Broder

Haupfear

et al. 2015

Open Forum Infectious Diseases

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Lot-to-lot consistency of a tetravalent dengue vaccine in healthy adults in Australia: A randomised study

Cited by 22 publications

References 23 publications

Integrated immunogenicity analysis of a tetravalent dengue vaccine up to 4 y after vaccination

Integrated immunogenicity analysis of a tetravalent dengue vaccine up to 4 y after vaccination

The first licensed dengue vaccine: can it be used in travelers?

Influence of FcγRIIa-Expressing Cells on the Assessment of Neutralizing and Enhancing Serum Antibodies Elicited by a Live-Attenuated Tetravalent Dengue Vaccine

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