Preliminary aggregate safety and immunogenicity results from three trials of a purified inactivated Zika virus vaccine candidate: phase 1, randomised, double-blind, placebo-controlled clinical trials

Modjarrad, Kayvon; Lin, Leyi; George, Sarah L.; Stephenson, Kathryn E.; Eckels, Kenneth H.; Barrera, Rafael A. De La; Jarman, Richard G.; Sondergaard, Erica L; Tennant, Janice; Ansel, Jessica L.; Mills, Kristin T; Koren, Michael; Robb, Merlin L.; Barrett, Jill; Thompson, Jason; Kosel, Alison E; Dawson, Peter; Hale, Andrew J.; Tan, Chen; Walsh, Stephen R.; Meyer, Keith; Brien, James D.; Crowell, Trevor A; Blazevic, Azra; Mosby, K.; Larocca, Rafael A.; Abbink, Peter; Boyd, Michael; Bricault, Christine A.; Seaman, Michael S.; Basil, Anne; Walsh, Melissa J; Tonwe, Veronica; Hoft, Daniel F.; Thomas, Stephen J.; Barouch, Dan H.; Michael, Nelson L.

doi:10.1016/s0140-6736(17)33106-9

Cited by 176 publications

(170 citation statements)

References 27 publications

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“…The results from the first 3 trials indicate that recipients developed robust neutralizing antibody titers that on transfer into mice significantly reduced or eliminated viral titers following ZIKV challenge. 74 Adverse effects were reported by 84% of recipients but were relatively minor (eg, pain or tenderness at injection site, fatigue, headache, malaise).…”

Section: Current Status Of Vaccine Developmentmentioning

confidence: 99%

Zika Vaccine Development: Current Status

Poland

Ovsyannikova

Kennedy

2019

Mayo Clinic Proceedings

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Zika virus outbreaks have been explosive and unpredictable and have led to significant adverse health effectsdas well as considerable public anxiety. Significant scientific work has resulted in multiple candidate vaccines that are now undergoing further clinical development, with several vaccines now in phase 2 clinical trials. In this review, we survey current vaccine efforts, preclinical and clinical results, and ethical and other concerns that directly bear on vaccine development. It is clear that the world needs safe and effective vaccines to protect against Zika virus infection. Whether such vaccines can be developed through to licensure and public availability absent significant financial investment by countries, and other barriers discussed within this article, remains uncertain.

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Section: Current Status Of Vaccine Developmentmentioning

confidence: 99%

Zika Vaccine Development: Current Status

Poland

Ovsyannikova

Kennedy

2019

Mayo Clinic Proceedings

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“…In addition, an mRNA vaccine encoding the prM and E genes of a French Polynesian strain induced strong CD4+ T cell and neutralizing antibody responses in non-pregnant mice and protected mice and NHP from virus challenge (118). Importantly, it was recently reported that an inactivated virus vaccine was safe in humans and elicited neutralizing antibody responses that were higher than the protective threshold observed in animal studies (119). Several additional clinical trials testing different vaccine platforms including inactivated virus, DNA, mRNA, virus-vector and synthetic peptide vaccines are ongoing.…”

Section: Maternal Immunization To Protect Infants From Neonatal Pamentioning

confidence: 99%

The Impact of IgG Transplacental Transfer on Early Life Immunity

et al. 2018

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Pediatric vaccines have significantly reduced infectious disease-related infant mortality, but as protective immunity often require several infant vaccine doses; maternally-acquired antibodies are critical to protect infants during the first months of life. Consequently, immunization of pregnant women is an important strategy not only to protect mothers from infection, but also to provide immunity to young infants. Nevertheless, maternal immunization can also negatively impact early life immunity. In fact, maternal antibodies can interfere with the development of infant immune responses, though it is unclear if such interference is clinically significant. Moreover, the transplacental transfer of maternal immunoglobulin therapeutics can be harmful to the fetus. Thus, the risk/benefit of maternal immunization for both the mother and the fetus should be carefully weighed. In addition, it is critical to fully understand the mechanisms by which IgG is transferred across the placenta in order to develop optimal maternal and infant immunization strategies.

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“…Three ZIKV purified inactivated virus vaccine (ZPIV) phase I clinical trials (NCT02963909, NCT02952833, and NCT02937233 ) were reported as a combined interim analysis of the preliminary results for the identical group for each individual study 51 . These studies (Table 2) were conducted at Walter Reed Army Institute of Research (WRAIR), Silver Spring, MD, United States; Saint Louis University, Saint Louis, MO, United States; and Beth Israel Deaconess Medical Center (BIDMC), Boston, MA, United States.…”

Section: Vaccines In Clinical Trialsmentioning

confidence: 99%

Zika virus vaccines

2018

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The recent epidemic of Zika virus (ZIKV) in the Americas has revealed the devastating consequences of ZIKV infection, particularly in pregnant women. Congenital Zika syndrome, characterized by malformations and microcephaly in neonates as well as developmental challenges in children, highlights the need for the development of a safe and effective vaccine. Multiple vaccine candidates have been developed and have shown promising results in both animal models and phase I clinical trials. However, important challenges remain for clinical development of these vaccines. In this Progress, we discuss recent preclinical studies and lessons learned from first in-human clinical trials with ZIKV vaccines.

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Preliminary aggregate safety and immunogenicity results from three trials of a purified inactivated Zika virus vaccine candidate: phase 1, randomised, double-blind, placebo-controlled clinical trials

Abstract: Departments of the Army and Defense and National Institute of Allergy and Infectious Diseases.

Cited by 176 publications

References 27 publications

Zika Vaccine Development: Current Status

Zika Vaccine Development: Current Status

The Impact of IgG Transplacental Transfer on Early Life Immunity

Zika virus vaccines

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