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Cancer Vaccine

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine for Human Papillomavirus

Phase 1

Waitlist Available

Led By Cornelia L. Trimble, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 41 weeks

Awards & highlights

Study Summary

This trial is testing a new cancer vaccine and a cream to see if they can effectively treat cervical intraepithelial neoplasia.

Eligible Conditions

Human Papillomavirus
Precancerous Conditions
Cervical Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 41 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~41 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 41 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and tolerability as determined by number of participants with Serious Adverse Events

Secondary outcome measures

Change in histology (CIN3 or no CIN3) of biopsies between baseline and week 15

Change in histology (CIN3 or no CIN3) of biopsies between baseline and week 28

Change in number of lesions by serial digital colposcopy from week 0 to week 15

+5 more

Side effects data

From 2010 Phase 1 & 2 trial • 16 Patients • NCT00121173

22%

Fatigue/tiredness, flu-like symptoms

11%

Hot flashes

11%

Vaginal discharge

11%

Headache

11%

Injection site reaction

100%

80%

60%

40%

20%

Study treatment Arm

High Dose

Intermediate Dose

Low Dose

Trial Design

3Treatment groups

Experimental Treatment

Group I: Groups 1-3Experimental Treatment2 Interventions

Patients receive pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine intramuscularly (IM) on days 1 and 29 and TA-HPV vaccine IM on day 57.

Group II: Group 5Experimental Treatment3 Interventions

Patients receive pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine and TA-HPV vaccine as in groups 1-3, and imiquimod as in group 4.

Group III: Group 4Experimental Treatment1 Intervention

Patients receive topical imiquimod on days 1, 29, and 57.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TA-HPV

2008

Completed Phase 1

~80

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

2003

Completed Phase 2

~100

imiquimod

2008

Completed Phase 3

~750

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

557 Previous Clinical Trials

32,825 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,078 Total Patients Enrolled

Cornelia L. Trimble, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

1 Previous Clinical Trials

16 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For which conditions is pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine typically prescribed?

"The pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine is usually used to address scalp structure, but has also been applied as a remedy for conditions such as condylomata acuminata, superficial basal cell carcinoma, and facial ailments."

Answered by AI

Are investigators still recruiting participants for this research endeavor?

"The details available on clinicaltrials.gov demonstrate that this medical trial is actively enlisting participants. The study first went live on November 1st 2008 with the most recent edits being made in July 13th 2022."

Answered by AI

To what extent is this experiment populated with participants?

"Affirmative. Records from clinicaltrials.gov demonstrate that this research initiative, which was first published on November 1st 2008, is presently in the recruitment phase. Approximately 75 patients need to be enrolled across a single medical centre."

Answered by AI

Has the pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine been officially certified by the FDA?

"As this is an initial clinical trial, limited evidence of safety and efficacy exists so pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine has been awarded a score of 1."

Answered by AI

What other investigations have been conducted regarding the pNGVL4a-Sig/E7(detox)/HSP70 gene vaccine?

"At present, the pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine is undergoing 21 separate clinical trials with 5 in Phase 3. Houston, Texas has a few of these studies running but there are 84 other research sites scattered around the world for this medication."

Answered by AI

Recent research and studies

Science Translational MedicineJournal

Intramuscular Therapeutic Vaccination Targeting HPV16 Induces T Cell Responses That Localize in Mucosal Lesions

Maldonado, Leonel, Jessica E. Teague, Matthew P. Morrow, Iveta Jotova, T. C. Wu, Chenguang Wang, Cindy Desmarais, et al.. 2014. “Intramuscular Therapeutic Vaccination Targeting HPV16 Induces T Cell Responses That Localize in Mucosal Lesions”. Science Translational Medicine. American Association for the Advancement of Science (AAAS). doi:10.1126/scitranslmed.3007323.

mBioJournal

Development of DNA Vaccine Targeting E6 and E7 Proteins of Human Papillomavirus 16 (HPV16) and HPV18 for Immunotherapy in Combination with Recombinant Vaccinia Boost and PD-1 Antibody

Peng, Shiwen, Louise Ferrall, Stephanie Gaillard, Chenguang Wang, Wei-Yu Chi, Chuan-Hsiang Huang, Richard B. S. Roden, T.-C. Wu, Yung-Nien Chang, and Chien-Fu Hung. 2021. “Development of DNA Vaccine Targeting E6 and E7 Proteins of Human Papillomavirus 16 (HPV16) and HPV18 for Immunotherapy in Combination with Recombinant Vaccinia Boost and PD-1 Antibody”. Edited by Matthew S. Miller. Mbio. American Society for Microbiology. doi:10.1128/mbio.03224-20.

Clinical Cancer ResearchJournal

Local HPV Recombinant Vaccinia Boost Following Priming with an HPV DNA Vaccine Enhances Local Hpv-specific CD8+ T-cell–mediated Tumor Control in the Genital Tract

Sun, Yun-Yan, Shiwen Peng, Liping Han, Jin Qiu, Liwen Song, Yachea Tsai, Benjamin Yang, et al.. 2016. “Local HPV Recombinant Vaccinia Boost Following Priming with an HPV DNA Vaccine Enhances Local Hpv-specific CD8+ T-cell–mediated Tumor Control in the Genital Tract”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-15-0234.

clinicaltrials.govStudy