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Table 2 Clinical trials for HPV-associated pre-neoplastic lesions

From: Immunologic treatments for precancerous lesions and uterine cervical cancer

Vaccine

Antigen(s)

Phase

Lesions

ADXS11-001:

HPV-16 E7

II

CIN 2/3, VIN 3, VAIN 2

Lm secreting fusion/LLO-HPV-16 E7 protein (Lm-LLO-E7)

   

Procervix: adenylate cyclase protein vector delivering HPV16 and HPV18 E7 antigens

HPV-16 and HPV-18 E7

I/II

High-risk HPV infections before CIN appearance

MVA E2: Recombinant Modified Vaccinia Ankara (MVA) encoding E2 from BPV

Bovine Papillomavirus E2

I/II

CIN1-3

 

I/II

Male flat condyloma

 

II

High-grade CIN

TG4001/R3484:

HPV-16 E6/E7

IIa

CIN2/3

Recombinant MVA expressing E6-E7of HPV-16, and IL-2

 

IIb

 

Peptides: HPV E7 (aa 12–20) plus E7 lipopetide (PADRE helper peptide, linker peptide, and E7 peptide: aa 86–93) & Montanide ISA-51 adjuvant

HPV-16 E7

I

High-grade CIN and

 

II

VIN

 

II

VIN 3

  

HSIL

HPV-16 E6/ E7 fusion protein plus ISCOMATRIX adjuvant

HPV-16 E6 and E7

I

CIN 1–3, HPV-associated AIN in HIV-positive male

PD-E7: Modified HPV-16 E7/Hib protein D fusion protein & AS02B adjuvant

HPV-16 E7

I/II

CIN 1, CIN 3

SGN-00101: HPV-16 E7/M. bovis, Hsp65 fusion protein

HPV-16 E7

I/II

Anal HSIL

 

I/II

High-grade AIN

 

II

ASCUS and LSIL, recurrent respiratory papillomatosis, high-grade CIN

SGN-00101 in poly ICLC adjuvant

HPV-16 E7

I

CIN 1-3

ZYC101: Recombinant HPV-16 E7 DNA Plasmid encapsulated in poly microparticles

HPV-16 E7

I

High-grade AIN in males, CIN 2/3

ZYC101a: Recombinant HPV-16 and HPV 18 E6-E7 DNA Plasmid encapsulated in poly microparticles

HPV-16 and HPV-18 E6 and E7

II/III

High grade CIN

pNGVL4a-Sig/E7/Hsp70: DNA plasmid expressing mutated HPV-16 E7 fused to Sig and Hsp70

HPV-16 E7

I

CIN 2/3

pNGVL4a-CRT/E7: DNA plasmid expressing mutated HPV-16 E7 fused to calreticulin

HPV-16 E7

I

CIN 2/3

VGX-3100: DNA plasmid expressing HPV-16 and HPV-18 E6 and E7 proteins

HPV-16 and HPV-18 E6 and E7

I

CIN 2/3 (after surgery or fourth dose)

 

II

CIN 2/3

TA-CIN/TA-HPV prime/boost

HPV-16 and HPV-18 E6 and E7 and HPV-16 L2

II

CIN 2/3

TA-HPV/TA-CIN prime/boost

HPV-16 and HPV-18 E6 and E7 and HPV-16 L2

II

CIN 2/3

pNGVL4a-Sig/E7 /Hsp70 and TA-HPV prime/boost plus TLR agonist imiquimod

HPV-16 and HPV-18 E6 and E7

II

CIN 2/3

  1. Note: Abbreviations are as in the text.