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. 2023 Jan 28;11(2):280. doi: 10.3390/vaccines11020280

Table 3.

Emerging infectious disease plasmid DNA vaccines administered with NFIS.

Indication Name
(Immunogen)		 Species Device (Route) Dose Schedule Vs NS NFIS Notes
VEEV [94] pWRG/VEE
(E3-E2-6K-E1)		 NHP Tropis (ID)
Stratis (IM)		 0.4 mg, 2 mg 0, 4 wk No

  • IM route more immunogenic while ID more protective
Hantavirus (SNV, ANDV) [95] M Rabbit, NHP Stratis (IM)
IMv1
IDv1		 Rabbit
0.4 mg, 2 mg, 4 mg *

NHP
1 mg *, 2 mg *		 0, 4, 8 wk Yes

  • NFIS more immunogenic than NS; IM more than ID

  • Combining vaccines feasible

  • NFIS more pragmatic, less cumbersome than EP and PMED
Hantavirus
(ANDV)
Zika

[96]		 ANDV: M
ZIKV: PrM, E		 Rabbit, NHP Stratis (IM) Rabbit
LNP: 0.001–1 mg
No LNP: 0.1 mg

NHP
LNP: 0.1 mg, 0.3 mg
No LNP: 0.1 mg,
0.3 mg, 2 mg		 Rabbit
0, 27 d
0, 42 d

NHP
0, 28, 56 d		 No

  • Used Arcturus Therapeutics LUNAR LNP formulation

  • In vivo, LNP formulation increased immunogenicity and showed dose sparing

  • In vitro, LNP formulation showed increased protein expression
Zika [97] VRC5283, VRC5288
(PrM, E)		 NHP Stratis (IM) 1 mg, 4 mg 0, 4 wk
C: 8 wk		 No

  • Correlation between neutralizing response and protection
Zika [98] VRC5283
(PrM, E)		 NHP Stratis (IM) 1 mg 0, 4 wk
C: 30, 60, 90 d		 No

  • Pregnant macaque model

  • Durable nAb response that correlated to aviremia

  • Transplacental antibody transfer and improved fetal outcomes
Zika [17] VRC5283
(PrM, E)		 Human
Ph 1		 Stratis (IM) 4 mg * 0, 4, 8 wk Yes

  • NFIS 100% seroconversion, higher immunogenicity than NS

  • Split dosing yielded higher immunogenicity

* = total dose administered in multiple injections at the same timepoint; NFIS = needle-free injection systems; vs. = versus; NS = needle and syringe; VEEV = Venezuelan equine encephalitis virus; NHP = non-human primate; ID = intradermal; IM = intramuscular; wk = week; SNV = Sin Nombre virus; ANDV = Andes orthohantavirus; M = membrane; IMv1 = first-generation PharmaJet IM NFIS; IDv1 = first-generation PharmaJet ID NFIS; EP = electroporation; PMED = particle-mediated epidermal delivery; ZIKV = Zika virus; PrM = pre-membrane; E = envelope; LNP = lipid nanoparticle; d = day; C = challenge, nAb = neutralizing antibody; Ph = phase.