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

J. Mascola | T. Pierson | C. Andrews | J. Casazza | M. Mulligan | C. DeMaso | R. Bailer | B. Graham | Zonghui Hu | J. Ledgerwood | Xiaolin Wang | N. Rouphael | R. Schwartz | Wilbur H. Chen | S. Edupuganti | Katherine V Houser | K. Lyke | S. Hickman | Jennifer Cunningham | C. Laurencot | G. Yamshchikov | J. Cox | A. Ross | Kathryn L. Zephir | I. Gordon | L. Holman | S. Plummer | C. S. Hendel | L. Novik | P. Costner | Floreliz H. Mendoza | J. Saunders | M. Conan-Cibotti | S. Sitar | H. Decederfelt | W. Whalen | N. Berkowitz | Kimberly A. Dowd | Allison Beck | Ingelise J. Gordon | Sarah H. Plummer | Pamela J M Costner | Katherine V. Houser | M. Gaudinski | Kaitlyn M. Morabito | R. S. Rothwell | Monica A McArthur | Ginny E Cummings | B. Foreman | Katherine E. Burgomaster | R. S. Pelc | David N. Gordon | Grace L. Chen | Sarah Pamela Kathryn Joseph Abidemi Milalynn Carol Willi Plummer Costner Zephir Casazza Ola Victorin | A. Ola | M. Victorino | Carol Levinson | O. Vasilenko | Maria Claudia Burgos Florez | Iris R Pittman | L. Le | B. Larkin | Preeti Apte | Renunda Hicks | Cora Trelles Cartagena | P. Williams | Catina R. Boyd | Judy A Stein | F. Kaltovich | Stacey McAdams | Phyllis Renehan | Nancy Greenberg | Nancy Wymer | L. Wadsworth | M. Billington | Toni Robinson | C. Boyce | Faith Pa'ahana Brown | Lisa Chrisley | Alyson Kwon | Prashanti Patel | P. Kominou | B. Dorsey | Staci Eddington | Shinyi Telscher | Myoughee Lee | R. Mosely | G. Ford | B. Domjahn | Jianguo Xu | R. Fineman | S. Heeke | J. Winter | S. Nagar | C. Kelley | Richard M. Schwartz | Iris Pittman | Colleen F. Kelley | Melissa Billington | Abidemi Ola | Ginny E. Cummings | M. B. Burgos Florez | Judy A. Stein | Maria C. Burgos Florez | Abidemi O. Ola | Srilatha Edupuganti | Ro Shauna S Rothwell

[1]  pNuha Algarzaep Zika virus outbreak , 2019 .

[2]  S. Trottier,et al.  Safety and Immunogenicity of an Anti-Zika Virus DNA Vaccine - Preliminary Report. , 2017, The New England journal of medicine.

[3]  B. Duncan,et al.  Infection-related microcephaly after the 2015 and 2016 Zika virus outbreaks in Brazil: a surveillance-based analysis , 2017, The Lancet.

[4]  Jisoo Kim,et al.  Zika Virus Transmission — Region of the Americas, May 15, 2015–December 15, 2016 , 2017, MMWR. Morbidity and mortality weekly report.

[5]  Carolina M. Voloch,et al.  Evidence for Transmission of Zika Virus by Platelet Transfusion , 2017 .

[6]  J. Mascola,et al.  Rapid development of a DNA vaccine for Zika virus , 2016, Science.

[7]  N. Low,et al.  Zika Virus Infection as a Cause of Congenital Brain Abnormalities and Guillain–Barré Syndrome: Systematic Review , 2016, bioRxiv.

[8]  Richard G. Jarman,et al.  Vaccine Protection Against Zika Virus from Brazil , 2016, Nature.

[9]  M. Sapiano,et al.  Survey of Blood Collection Centers and Implementation of Guidance for Prevention of Transfusion-Transmitted Zika Virus Infection--Puerto Rico, 2016. , 2016, MMWR. Morbidity and mortality weekly report.

[10]  Anthony S Fauci,et al.  Zika Virus in the Americas--Yet Another Arbovirus Threat. , 2016, The New England journal of medicine.

[11]  Amadou Alpha Sall,et al.  Zika virus and microcephaly: why is this situation a PHEIC? , 2016, The Lancet.

[12]  G. Screaton,et al.  New insights into the immunopathology and control of dengue virus infection , 2015, Nature Reviews Immunology.

[13]  Xia Jin,et al.  Guiding dengue vaccine development using knowledge gained from the success of the yellow fever vaccine , 2015, Cellular and Molecular Immunology.

[14]  S. Sardi,et al.  Zika Virus Outbreak, Bahia, Brazil , 2015, Emerging infectious diseases.

[15]  J. Derraik,et al.  Notes on Zika virus – an emerging pathogen now present in the South Pacific , 2015, Australian and New Zealand journal of public health.

[16]  T. Pierson,et al.  Vaccine Development as a Means to Control Dengue Virus Pathogenesis: Do We Know Enough? , 2014, Annual review of virology.

[17]  J. Mascola,et al.  Safety and Immunogenicity of DNA Vaccines Encoding Ebolavirus and Marburgvirus Wild-Type Glycoproteins in a Phase I Clinical Trial , 2014, The Journal of infectious diseases.

[18]  J. Mascola,et al.  DNA Vaccine Delivered by a Needle-Free Injection Device Improves Potency of Priming for Antibody and CD8+ T-Cell Responses after rAd5 Boost in a Randomized Clinical Trial , 2013, PloS one.

[19]  J. Mascola,et al.  DNA priming and influenza vaccine immunogenicity: two phase 1 open label randomised clinical trials , 2011, The Lancet Infectious Diseases.

[20]  K. Porter,et al.  Evaluation of a prototype dengue-1 DNA vaccine in a Phase 1 clinical trial. , 2011, Vaccine.

[21]  P. Bourdillon,et al.  Circadian Variation in QT Interval Demonstrating Assay Sensitivity in a Phase 1 Clinical Trial , 2010 .

[22]  R. Lanciotti,et al.  Zika virus outbreak on Yap Island, Federated States of Micronesia. , 2009, The New England journal of medicine.

[23]  J. Mascola,et al.  A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial , 2008, Vaccine.

[24]  M. Fay,et al.  A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults during a phase 1 clinical trial. , 2007, The Journal of infectious diseases.

[25]  J. Mascola,et al.  Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine. , 2006, The Journal of infectious diseases.

[26]  R. Koup,et al.  A DNA Vaccine for Ebola Virus Is Safe and Immunogenic in a Phase I Clinical Trial , 2006, Clinical and Vaccine Immunology.

[27]  C. Andrews,et al.  Toxicological safety evaluation of DNA plasmid vaccines against HIV-1, Ebola, Severe Acute Respiratory Syndrome, or West Nile virus is similar despite differing plasmid backbones or gene-inserts. , 2006, Toxicological sciences : an official journal of the Society of Toxicology.

[28]  R. Doms,et al.  West Nile Virus Discriminates between DC-SIGN and DC-SIGNR for Cellular Attachment and Infection , 2006, Journal of Virology.

[29]  Tao Dong,et al.  Original antigenic sin and apoptosis in the pathogenesis of dengue hemorrhagic fever , 2003, Nature Medicine.

[30]  Denise A. Martin,et al.  West Nile Virus Recombinant DNA Vaccine Protects Mouse and Horse from Virus Challenge and Expresses In Vitro a Noninfectious Recombinant Antigen That Can Be Used in Enzyme-Linked Immunosorbent Assays , 2001, Journal of Virology.

[31]  C. Mandl,et al.  Synthesis and secretion of recombinant tick-borne encephalitis virus protein E in soluble and particulate form , 1995, Journal of virology.

[32]  F. Ennis,et al.  Dengue virus-specific cross-reactive CD8+ human cytotoxic T lymphocytes , 1989, Journal of virology.

[33]  G. Dick,et al.  Zika virus. I. Isolations and serological specificity. , 1952, Transactions of the Royal Society of Tropical Medicine and Hygiene.

[34]  T. Huisman,et al.  Evidence of Sexual Transmission of Zika Virus , 2016 .