Safety and Immunogenicity of Different Formulations of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico: Final Results after 3 Years of Follow-Up from a Randomized, Placebo-Controlled Phase I Study

Díaz, Clemente; Koren, Michael; Lin, Leyi; Martínez, Luis; Eckels, Kenneth H.; Campos, Maribel; Jarman, Richard G.; Barrera, Rafael De La; Lepine, Edith; Febo, Irma; Vaughn, David W.; Wilson, Todd M.; Paris, Robert; Schmidt, Alexander; Thomas, Stephen J.

doi:10.4269/ajtmh.19-0461

Cited by 9 publications

(3 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Three clinical studies comparing various dose levels, adjuvants, and schedules have been completed. These included Phase 1 (172) and Phase 1/2 (173) studies in denguenaïve adults, and a Phase 1 study in Puerto Rican adults (174,175), most of whom were previously exposed to dengue. In the dengue-naïve populations, two doses of DPIV adjuvanted with GSK's proprietary AS03B adjuvant given intramuscularly one month apart induced a tetravalent neutralizing antibody response in 100 percent of subjects at one month after the second dose.…”

Section: Dengue Vaccine Developmentmentioning

confidence: 99%

Controlled Human Infection Models To Accelerate Vaccine Development

et al. 2022

View full text Add to dashboard Cite

The timelines for developing vaccines against infectious diseases are lengthy, and often vaccines that reach the stage of large phase 3 field trials fail to provide the desired level of protective efficacy. The application of controlled human challenge models of infection and disease at the appropriate stages of development could accelerate development of candidate vaccines and, in fact, has done so successfully in some limited cases.

show abstract

Section: Dengue Vaccine Developmentmentioning

confidence: 99%

Controlled Human Infection Models To Accelerate Vaccine Development

et al. 2022

View full text Add to dashboard Cite

show abstract

“…The tetravalent purified formalin-inactivated virus (TPIV), which contains four nonactive dengue serotypes, is an example of an inactivated vaccine now in clinical trials [42]. TDENV PIV/AS03B is now being investigated in a clinical study with various dosing regimens [24,25]. In both flavivirus-naive and experienced groups of infected individuals, TDEV PIV was well tolerated and immunogenic.…”

Section: Inactivated Vaccinesmentioning

confidence: 99%

Updates on Dengue Vaccine and Antiviral: Where Are We Heading?

2021

View full text Add to dashboard Cite

Approximately 100–400 million people from more than 100 countries in the tropical and subtropical world are affected by dengue infections. Recent scientific breakthroughs have brought new insights into novel strategies for the production of dengue antivirals and vaccines. The search for specific dengue inhibitors is expanding, and the mechanisms for evaluating the efficacy of novel drugs are currently established, allowing for expedited translation into human trials. Furthermore, in the aftermath of the only FDA-approved vaccine, Dengvaxia, a safer and more effective dengue vaccine candidate is making its way through the clinical trials. Until an effective antiviral therapy and licensed vaccine are available, disease monitoring and vector population control will be the mainstays of dengue prevention. In this article, we highlighted recent advances made in the perspectives of efforts made recently, in dengue vaccine development and dengue antiviral drug.

show abstract

“…A placebo group received saline as a control. Safety data and immune responses to DENV-1-4 as evaluated by microneutralization assay were also reported in a long-term follow-up study 14 . Here, we report results of the exploratory objectives from these studies, which were to evaluate cell-mediated immunity (CMI) elicited by each of the four DPIV formulations in terms of antigen-specific memory B-cell and T-cell responses.…”

Section: Introductionmentioning

confidence: 99%

Characterization of B-cell and T-cell responses to a tetravalent dengue purified inactivated vaccine in healthy adults

et al. 2022

Self Cite

View full text Add to dashboard Cite

The increasing global impact of dengue underscores the need for a dengue virus (DENV) vaccine. We assessed B-cell and T-cell responses following vaccination with four formulations of a tetravalent dengue purified inactivated vaccine (DPIV) in dengue-primed and dengue-naive adults from two studies (NCT01666652, NCT01702857). Frequencies of DPIV-induced memory B cells specific to each DENV serotype remained high up to 12 months post-vaccination, and were higher in the dengue-primed than dengue-naive adults. A subsequent DPIV booster dose induced strong anamnestic B-cell responses. Multifunctional CD4+ T cells (predominantly expressing IL-2) were induced by DPIV, with higher frequencies in dengue-primed adults. DPIV-induced CD4+ T cells also demonstrated in vitro proliferative capacity and antigen-specific production of GM-CSF, IFN-γ, and IL-13. CD8+ T-cell responses were undetectable in dengue-naive adults and low in dengue-primed individuals. B- and T-cell responses persisted up to 12 months post-vaccination in both dengue-primed and dengue-naive adults.

show abstract

Safety and Immunogenicity of Different Formulations of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico: Final Results after 3 Years of Follow-Up from a Randomized, Placebo-Controlled Phase I Study

Cited by 9 publications

References 14 publications

Controlled Human Infection Models To Accelerate Vaccine Development

Controlled Human Infection Models To Accelerate Vaccine Development

Updates on Dengue Vaccine and Antiviral: Where Are We Heading?

Characterization of B-cell and T-cell responses to a tetravalent dengue purified inactivated vaccine in healthy adults

Contact Info

Product

Resources

About