NCT03911076: PVX2

Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL

Terminated Phase 2 Last updated 17 June 2024

What this trial tests

Phase 2 trial testing PVX-2 in ASC-US in 16 participants. Terminated before completion.

Timeline

22 May 2019

Primary endpoint
8 June 2022

8 June 2022

Quick facts

Lead sponsor	PapiVax Biotech, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	16
Start date	22 May 2019
Primary completion	8 June 2022
Estimated completion	8 June 2022
Sites	6 locations across United States

Drugs / interventions tested

• PVX-2 — full drug profile →
• Placebo

Conditions studied

• ASC-US — all drugs for ASC-US →
• ASC-H — all drugs for ASC-H →
• LSIL — all drugs for LSIL →

Sponsor

PapiVax Biotech, Inc. — full company profile →

Who can join

Adults 25 to 70, female only, with ASC-US or ASC-H. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

* To evaluate the safety and tolerability of the dual IM pNGVL4a Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen
* To evaluate the efficacy of dual IM pNGVL4a-Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen on Human Papillomavirus (HPV) 16 clearance by Month 6

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cervical Cancer Immunotherapy: Facts and Hopes.
   Ferrall L, Lin KY, Roden RBS, Hung CF, et al · · 2021 · cited 255× · PMID 33888488 · DOI 10.1158/1078-0432.ccr-20-2833
2. Prophylactic and Therapeutic HPV Vaccines: Current Scenario and Perspectives.
   Mo Y, Ma J, Zhang H, Shen J, et al · · 2022 · cited 90× · PMID 35860379 · DOI 10.3389/fcimb.2022.909223
3. An Update on Human Papilloma Virus Vaccines: History, Types, Protection, and Efficacy.
   Yousefi Z, Aria H, Ghaedrahmati F, Bakhtiari T, et al · · 2021 · cited 87× · PMID 35154080 · DOI 10.3389/fimmu.2021.805695
4. Therapeutic Vaccines for HPV-Associated Malignancies.
   Smalley Rumfield C, Roller N, Pellom ST, Schlom J, et al · · 2020 · cited 87× · PMID 33117742 · DOI 10.2147/itt.s273327
5. The next-generation DNA vaccine platforms and delivery systems: advances, challenges and prospects.
   Lu B, Lim JM, Yu B, Song S, et al · · 2024 · cited 84× · PMID 38361919 · DOI 10.3389/fimmu.2024.1332939
6. Heat Shock Proteins and HSF1 in Cancer.
   Cyran AM, Zhitkovich A. · · 2022 · cited 79× · PMID 35311075 · DOI 10.3389/fonc.2022.860320
7. Similarities and Differences of Hsp70, hsc70, Grp78 and Mortalin as Cancer Biomarkers and Drug Targets.
   Rai R, Kennedy AL, Isingizwe ZR, Javadian P, et al · · 2021 · cited 40× · PMID 34831218 · DOI 10.3390/cells10112996
8. The Interplay between Heat Shock Proteins and Cancer Pathogenesis: A Novel Strategy for Cancer Therapeutics.
   Somu P, Mohanty S, Basavegowda N, Yadav AK, et al · · 2024 · cited 28× · PMID 38339390 · DOI 10.3390/cancers16030638