Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials

Gaudinski, Martin R.; Houser, Katherine V.; Morabito, Kaitlyn M.; Hu, Zonghui; Yamshchikov, Galina V.; Rothwell, Ro Shauna; Berkowitz, Nina M.; Mendoza, Floreliz; Saunders, Jamie; Novik, Laura; Hendel, Cynthia S.; Holman, LaSonji A.; Gordon, Ingelise J.; Cox, Josephine H.; Edupuganti, Srilatha; McArthur, Monica A.; Rouphael, Nadine; Lyke, Kirsten E.; Cummings, Ginny E.; Sitar, Sandra; Bailer, Robert T.; Foreman, Bryant M.; Burgomaster, Katherine E.; Pelc, Rebecca S.; Gordon, David; DeMaso, Christina R.; Dowd, Kimberly A.; Laurençot, Carolyn M.; Schwartz, Richard; Mascola, John R.; Graham, Barney S.; Pierson, Theodore C.; Ledgerwood, Julie E.; Chen, Grace L.; Plummer, Sarah H.; Costner, Pamela; Zephir, Kathryn L; Casazza, Joseph P.; Ola, Abidemi; Victorino, Milalynn; Levinson, Carol; Whalen, William; Wang, Xiaolin; Cunningham, Jennifer; Василенко, О. А.; Florez, Maria Burgos; Hickman, Somia P.; Pittman, Iris; Le, Lam; Larkin, Brenda; Andrews, Charla; Apte, Preeti; Hicks, Renunda; Cartagena, Cora Trelles; Williams, Pernell; Boyd, Catina R.; Conan-Cibotti, Michelle; Stein, Judy; Kaltovich, Florence; Decederfelt, Hope; McAdams, Stacey; Renehan, Phyllis; Chen, Wilbur; Greenberg, Nancy; Wymer, Nancy; Wadsworth, Linda; Billington, Melissa; Robinson, T.; Boyce, Colleen; Brown, Faith Pa'ahana; Chrisley, Lisa; Kwon, Alyson; Patel, Prashant; Kominou, Panagoita; Dorsey, Brenda; Eddington, Staci; Telscher, Shinyi; Lee, Myoughee; Mosely, R.; Ross, April; Ford, Geoffrey; Domjahn, Briyana; Xu, Jianguo; Beck, Allison; Fineman, Rebecca; Heeke, Shiela; Winter, Jean M.; Nagar, Shashi; Kelley, Colleen F.; Mulligan, Mark J.

doi:10.1016/s0140-6736(17)33105-7

Cited by 255 publications

(204 citation statements)

References 32 publications

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“…Promising DNA, mRNA, and purified inactivated virus vaccines that could be used to prevent ZIKV are currently in phase I or phase II clinical trials …”

Section: Treatment and Preventionmentioning

confidence: 99%

Zika virus during pregnancy: From maternal exposure to congenital Zika virus syndrome

et al. 2019

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What is already known about the topic? The Zika virus (ZIKV) emergence and its consequences during pregnancy led to an increasing number of data about the maternal and fetal consequences of ZIKV infections. What does this study add? This review evaluates risks of maternal ZIKV infection, maternal‐fetal transmission, congenital Zika syndrome (CZS), other adverse perinatal outcomes, and long‐term sequelae among pregnancies exposed to ZIKV. This review also provides contemporary criteria and guidelines for the follow‐up of exposed fetuses, based on prenatal and postnatal features of CZS.

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“…Promising DNA, mRNA, and purified inactivated virus vaccines that could be used to prevent ZIKV are currently in phase I or phase II clinical trials …”

Section: Treatment and Preventionmentioning

confidence: 99%

Zika virus during pregnancy: From maternal exposure to congenital Zika virus syndrome

et al. 2019

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“…It is currently undergoing a phase 2 clinical trial in healthy adults aged 18 to 35 years (NCT03110770), along with VRC-ZKADNA085-00-VP, a similar DNA-based plasmid vaccine also encoding the prM and E proteins of the H/PF/2013 strain of ZIKV (NCT028404 87). 78,79 Animal studies demonstrated that these vaccine candidates were highly immunogenic in BALB/c and C57BL/6 mice, eliciting high-titer neutralizing antibodies at 2-, 10-, and 50-ug doses. A 2-dose vaccination schedule in rhesus macaques elicited virusbinding and virus-neutralizing antibody responses.…”

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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“…The first DNA vaccine was designed to express ZIKV prM-ENV with a JEV envelope stem region; the JEV stem was added to increase sub-virus particle formation (vaccine VRC5288 and study VRC319; clinical trial NCT02840487). The second DNA vaccine expressed wild-type ZIKV prM-ENV (vaccine VRC5283 and study VRC320; clinical trial NCT02996461) 49 . In study VRC319, participants received 4 mg doses at 0 and 8 weeks, 0 and 12 weeks, 0, 4, and 8 weeks, or 0, 4, and 20 weeks by intra-muscular injection (Table 2).…”

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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Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials

Abstract: Intramural Research Program of the Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health.

Cited by 255 publications

References 32 publications

Zika virus during pregnancy: From maternal exposure to congenital Zika virus syndrome

Zika virus during pregnancy: From maternal exposure to congenital Zika virus syndrome

Zika Vaccine Development: Current Status

Zika virus vaccines

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