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

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

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials
Creator	Bailer, Robert Hu, Zonghui Gordon, David Sitar, Sandra Mascola, John Burgomaster, Katherine Laurencot, Carolyn Yamshchikov, Galina Foreman, Bryant Graham, Barney Houser, Katherine Pierson, Theodore Schwartz, Richard Berkowitz, Floreliz Cox, Srilatha Cummings, Ginny Demaso, Christina Dowd, Kimberly Gaudinski, Martin Gordon, Josephine Hendel, Lasonji Holman, Ingelise Lyke, Kirsten Mcarthur, Monica Mendoza, Jamie Morabito, Kaitlyn Novik, Cynthia Pelc, Rebecca Ro, Shauna Rothwell, Nina Rouphael, Nadine Saunders, Laura
Source	Elsevier; Medline; PMC
abstract	Summary Background The Zika virus epidemic and associated congenital infections have prompted rapid vaccine development. We assessed two new DNA vaccines expressing premembrane and envelope Zika virus structural proteins. Methods We did two phase 1, randomised, open-label trials involving healthy adult volunteers. The VRC 319 trial, done in three centres, assessed plasmid VRC5288 (Zika virus and Japanese encephalitis virus chimera), and the VRC 320, done in one centre, assessed plasmid VRC5283 (wild-type Zika virus). Eligible participants were aged 18–35 years in VRC19 and 18–50 years in VRC 320. Participants were randomly assigned 1:1 by a computer-generated randomisation schedule prepared by the study statistician. All participants received intramuscular injection of 4 mg vaccine. In VRC 319 participants were assigned to receive vaccinations via needle and syringe at 0 and 8 weeks, 0 and 12 weeks, 0, 4, and 8 weeks, or 0, 4, and 20 weeks. In VRC 320 participants were assigned to receive vaccinations at 0, 4, and 8 weeks via single-dose needle and syringe injection in one deltoid or split-dose needle and syringe or needle-free injection with the Stratis device (Pharmajet, Golden, CO, USA) in each deltoid. Both trials followed up volunteers for 24 months for the primary endpoint of safety, assessed as local and systemic reactogenicity in the 7 days after each vaccination and all adverse events in the 28 days after each vaccination. The secondary endpoint in both trials was immunogenicity 4 weeks after last vaccination. These trials are registered with ClinicalTrials.gov, numbers NCT02840487 and NCT02996461. Findings VRC 319 enrolled 80 participants (20 in each group), and VRC 320 enrolled 45 participants (15 in each group). One participant in VRC 319 and two in VRC 320 withdrew after one dose of vaccine, but were included in the safety analyses. Both vaccines were safe and well tolerated. All local and systemic symptoms were mild to moderate. In both studies, pain and tenderness at the injection site was the most frequent local symptoms (37 [46%] of 80 participants in VRC 319 and 36 [80%] of 45 in VRC 320) and malaise and headache were the most frequent systemic symptoms (22 [27%] and 18 [22%], respectively, in VRC 319 and 17 [38%] and 15 [33%], respectively, in VRC 320). For VRC5283, 14 of 14 (100%) participants who received split-dose vaccinations by needle-free injection had detectable positive antibody responses, and the geometric mean titre of 304 was the highest across all groups in both trials. Interpretation VRC5283 was well tolerated and has advanced to phase 2 efficacy testing. Funding Intramural Research Program of the Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health.
has issue date	2018-02-16(xsd:dateTime)
bibo:doi	10.1016/s0140-6736(17)33105-7
bibo:pmid	29217376
has license	els-covid
sha1sum (hex)	074a55da5161bcf7f63991d18567e99b0dc98fb4
schema:url	https://doi.org/10.1016/s0140-6736%2817%2933105-7
resource representing a document's title	Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials
has PubMed Central identifier	PMC6379903
has PubMed identifier	29217376
schema:publication	The Lancet
resource representing a document's body	covid:074a55da5161bcf7f63991d18567e99b0dc98fb4#body_text
is schema:about of	named entity 'HEALTHY' named entity 'volunteers' named entity 'vaccination' named entity 'immunogenicity' named entity 'weeks' named entity 'receive' named entity 'prepared' named entity 'DNA vaccine' named entity 'adults' named entity 'DNA VACCINE' named entity 'ADULTS' named entity 'STUDY' named entity 'VACCINE' named entity 'HEALTHY ADULT' named entity 'TOLERABILITY' named entity 'INTRAMUSCULAR INJECTION' named entity 'SINGLE' named entity 'FOLLOWED' named entity 'RECEIVED' named entity '20 WEEKS' named entity 'NEEDLE' named entity 'VACCINATIONS' named entity 'COMPUTER' named entity 'PARTICIPANTS' named entity 'DEVICE' named entity 'DAYS' named entity 'PHASE 1' named entity 'SPLIT' named entity 'YEARS' named entity 'ZIKA VIRUS' named entity 'REGISTERED' named entity 'VRC' named entity 'PRIMARY ENDPOINT' named entity 'ASSESSED' named entity 'STATISTICIAN' named entity 'CENTRE' named entity 'RANDOMISATION' named entity 'PHASE 1 CLINICAL TRIALS' named entity 'IMMUNOGENICITY' named entity 'LABEL' named entity '320' named entity 'IMMUNOGENICITY' named entity 'DELTOID' named entity 'VIRUS' named entity 'VIRUS DNA' named entity 'OPEN' named entity 'SAFETY' named entity 'CENTRES' named entity '12 WEEKS' named entity '4 WEEKS'

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