Table 3.
Zika virus vaccines: published pre-clinical studies and Phase I clinical trials.
| Vaccine | Sponsor | N | Type 1 | Location | Designation 2 | Entered into CTG 3 | Study opened | Reference |
|---|---|---|---|---|---|---|---|---|
| DNA plasmid | ||||||||
| GLS-5700 | GeneOne | 40 | OL, DR | PA, FL, Que 6 | NCT02809443 | 20 Jun 2016 | Jun 2016 | 144 |
| GeneOne | 160 | PC, DB | PR 7 | NCT02887482 | 24 Aug 2016 | Aug 2016 | ||
| VRC-ZKADNA085-00-VP (VRC5288) 4 | NIAID | 80 | OL | GA, MD 6 | NCT02840487 | 19 Jul 2016 | Aug 2016 | 140,141,143 |
| VRC-ZKADNA909-00-VP (VRC5283) 4 | NIAID | 50 | OL | MD 7 | NCT02996461 | 16 Dec 2016 | Dec 2016 | 140,141,143 |
| mRNA | ||||||||
| mRNA-1325 | Moderna | 90 | OL, DR | CA, FL, IL 7 | NCT03014089 | 5 Jan 2017 | Jan 2017 | 146 |
| PIV | ||||||||
| ZPIV 5 | Beth Israel | 48 | DR, PC, DB | MA 7 | NCT02937233 | 12 Oct 2016 | Oct 2016 | 140,143 |
| NIAID | 75 | OL, DR | MO 7 | NCT02952833 | 13 Oct 2016 | Oct 2016 | ||
| NIAID | 90 | OL | MD 7 | NCT02963909 | 10 Nov 2016 | Nov 2016 | ||
| NIAID | 90 | DR, PC, DB | PR 7 | NCT03008122 | 15 Dec 2016 | Dec 2016 | ||
| Viral Vectored - MV | ||||||||
| MV-ZIKA | Themis | 48 | DR, PC, DB | Austria 7 | NCT02996890 | 15 Dec 2016 | Apr 2017 |
Study type: OL, open label; DR, dose ranging; PC, placebo-controlled; DB, double-blind.
Clinical Trials Gov designation.
Date entered into Clinical Trials Gov.
VRC5283 is a chimeric vaccine expressing JEV prM region that precedes the entire wild-type Zika virus envelope; VRC5288 is a chimeric vaccine that includes the JEV prM region preceding the first 98 amino acids of the Zika virus envelope and the stem and transmembrane regions from JEV.
For clinical trial NCT02963909 ZPIV is either given alone with alum or with Japanese encephalitis virus (JEV) vaccine Ixiaro (inactivated) or with Yellow Fever virus (YFV) vaccine YF-Vax (live virus vaccine that includes strain 17D. For trials NCT03008122 and NCT02952833.
ZPIV is administered with alum, whereas for trial NCT02937233 ZPIV is given without alum adjuvant.
The indicated studies have completed enrollment. Abbreviations: PA, Pennsylvania; FL, Florida; Que, Quebec City; GA, Georgia; MD, Maryland. GLS-5700 is being co-developed by GeneOne Life Science Inc. and Inovio Pharmaceuticals Inc.
The indicated studies have ongoing enrollment at the time of writing. Abbreviations: PR, Puerto Rico; CA, California; IL, Illinois; MA, Massachusetts; MO, Missouri.