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Table 4 Selected clinical trials of nucleic acid‑based cancer vaccines

From: Cancer vaccines: current status and future directions

Platform

Vaccine: targets

Year, Phase, Reference

Target cancer

Route

Results

Sample number

DNA

VGX-3100: HPV-16/18 E6 and E7

2015, Phase IIb, NCT01304524 [70]

Adult women with histologically confirmed HPV-16 or HPV-18-positive stage 2/3 cervical intraepithelial neoplasia/167

Intramuscular

Higher histopathological regression rate (49.5%) versus placebo (30.6%)

Phase III, NCT03721978

Completed

DNA

GX-188E

2020, phase II, single-arm, NCT03444376 [115]

Histologically confirmed recurrent or advanced HPV-positive inoperable cervical cancer/36

Intramuscular

42% OR, 58% disease control, and 4.9-month median PFS

DNA

GNOS-PV02: up to 40 neoantigens

2024, phase I-II, single-arm, NCT04251117 [116]

Advanced HCC previously treated with a multityrosine kinase inhibitor/36

Intradermal

30.6% ORR and 8.3% CR

mRNA

mRNA-4157 (V940): up to 34 neoantigens

2024, phase IIb, NCT03897881 [146]

Completely resected stage IIIB–IV melanoma/157

Intramuscular

Longer recurrence-free survival versus pembrolizumab

Phase III, NCT05933577

High-risk stage II-IV cutaneous melanoma

Active, not recruiting

Phase III, NCT06077760

Completely resected Stage II, IIIA or IIIB NSCLC

Recruiting

mRNA

CV9202: six TAAs

Phase I-II, NCT03164772

Metastatic NSCLC

Intradermal

Completed

mRNA

BNT112: five prostate cancer TAAs

Phase I-IIa, NCT04382898

Metastatic castration-resistant prostate cancer and newly diagnosed high risk localized prostate cancer

Intravenous

Terminated

mRNA

BNT113: HPV E6 and E7

Phase I-II, NCT04534205

Unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1

Intravenous

Recruiting

mRNA

BNT116

Phase I, NCT05142189

Advanced, metastasized, and unresectable NSCLC

Intravenous

Recruiting

mRNA

CLDN6 (claudin 6)

Phase I, NCT04503278

CLDN6-positive relapsed or refractory advanced solid tumors

Intravenous

Recruiting

  1. OR, overall response; HCC, hepatocellular carcinoma; CR, complete response; HNSCC, Head and neck squamous cell carcinoma