. 2022 Feb 25;17:869–900. doi: 10.2147/IJN.S269986

Table 4.

Clinical Trials of Peptide-Based Vaccines Against Cervical Cancer

Vaccine	Vaccine Composition & Adjuvant	Phase/ Status	Clinical Trials	Outcomes	Ref
HPV-16 E7_11-20/86-93, peptide trial	HPV-16 E7_11-20, E7_86-93, and PADRE emulsified in Montanide ISA 51 adjuvant	I–II/ Completed	19 patients; dose-escalation study	15 patients developed progressive disease; 2 patients showed tumor regression with chemotherapy.	[131]
HPV-16 E7_11-20/86-93, peptide trial		I–II/ Completed	15 patients	No HPV-specific CTL response.	[130]
HPV-16 E7_12-20/86-93 peptide trial	HPV-16 E7_12-20, E7_86-93, and PADRE emulsified in Montanide ISA 51 adjuvant	I/ Completed	18 patients; dose-escalation study	10 patients showed HPV-16 E7 specific CTL response.	[129]
Five peptides for HLA-A*2402 cervical cancer	Five peptides: FOXM1-262, MELK-87-7N, HJURP-408, VEGFR-1-1084 and VEGFR-2-169 in Montanide ISA 51 adjuvant	I/ Completed	UMIN000003999: 9 patients; dose-escalation study	No toxicity and well-tolerated	[230]
WT-1 peptide trial	WT-1_187-195, GM-CSF, Montanide ISA 51 ±CpG7909	I/ Completed	UMIN000002771: 28 patients; 2 groups	Skin toxicity level and adverse effects	[231]
P16_37-63 peptide trial	p16_37-63 peptide of cellular protein P16^INK4 plus Montanide ISA-51 adjuvant	I–IIa/ Completed	NCT01462838: 26 patients; single group; open label	No dose-limited toxicity	[234]
P16_37-63 peptide trial	Cisplatin-based chemotherapy combined with p1637-63 peptide and Montanide ISA-51 adjuvant	I/ Completed	NCT02526316: 10 patients; single group; open label	No results posted	[241]
ISA 101	9 overlapping long E6 peptides and 4 overlapping E7 peptides from HPV-16 (HPV16-SLP) with Montanide ISA 51 adjuvant	I/ Completed	35 patients; 3 groups with different doses	Minimal toxicity and sustained immunogenicity	[225]
	HPV16-SLP with Montanide ISA 51 adjuvant	II/ Completed	20 patients; single group	12 patients showed clinical CTL responses.	[226]
	HPV16-SLP with Montanide ISA 51 adjuvant	II/ Completed	34 patients	All patients showed significant HPV-specific CTL response.	[227]
	HPV16-SLP, Montanide ISA 51 adjuvant, combined therapy with nivolumab (PD-1 inhibitor)	II/ Completed	NCT02426892: 24 patients; single-arm; single-center	No toxicity accumulation; well-tolerated	[245]
	HPV-SLP, Montanide ISA 51 adjuvant, CarboTaxol with/without Bevacizumab (pegylated IFNα as immune modulator)	I–II/ Completed	NCT02128126: 93 participants; multicenter; open label	No results posted	[242]
PepCan	Peptides from HPV-16 E6 with Candin/ Candin as active comparator	I/ Completed	NCT00569231: 24 patients; dose-escalation	No dose-limited toxicity	[236]
		II/ Recruitment	NCT02481414: 125 participants; randomized, doubled-blinded to two therapy arms	No results posted	[236]
		II/ Recruitment	NCT03821272	No results posted	[236]
PDS0101	Peptides from HPV-16 E6 and E7, and R-enantiomer of 1.2-dioleoyl-3-trimethylammonium- propane chloride (R-DOTAP)	I/ Completed	NCT02065973: 12 patients; open-label; sequential- cohort; escalating dose	Safety	[239]
PDS0101	Cisplatin, liposomal HPV-16 E6/E7 multipeptide with R-DOTAP and radiation therapy	IIA/ Recruitment	NCT04580771: 35 participants; interventional; single group assignment; open label	No results posted	[239]
DPX-E7	HPV-16 E7_49-57 and PADRE plus DepoVax™ (DPX) adjuvant	Ib-II/ Active, not recruiting	NCT02865135: 11 participants; interventional; single group assignment; open label	No results posted	[96,113]