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9vHPV + BCG Vaccine Mix for Human Papillomavirus (9vHPV-BCG Trial)

Q: Is this trial open to individuals of advanced age?

This medical trial requires applicants to be between 24 and 74 years of age. Conversely, 277 studies are available for those under 18 while 2502 exist for individuals older than 65.

Q: What is the aggregate figure of individuals participating in this clinical research endeavor?

At the present moment, this clinical trial is not enrolling any new patients. It was initially published on December 28th of 2021 and its information was most recently updated in November 21st 2022. If you are looking for alternative research opportunities, there are 2283 trials studying <a href="https://www.withpower.com/clinical-trials/covid">COVID</a>-19 currently recruiting participants and 429 studies examining ABIRATERONE - Group 2 seeking volunteers.

Q: Does this research program have any vacancies for participants?

This trial is not currently recruiting. Having been first posted on December 28th 2021 and last updated on November 21st 2022, it has temporarily suspended patient recruitment. For those looking for other trials, there are 2,283 clinical studies enrolling patients with <a href="https://www.withpower.com/clinical-trials/covid">COVID</a>-19 and 429 organisations seeking participants in the ABIRATERONE - Group 2 study group.

Q: Have any other experiments been conducted with ABIRATERONE - Group 2?

Presently, 429 trials are underway evaluating the efficacy of ABIRATERONE - Group 2, with 129 studies at Phase 3. Most of these analyses are located in Gothenburg and <a href="https://www.withpower.com/clinical-trials/iowa">Iowa</a>; however there are over 20,000 sites running tests for this pharmaceutical agent.

Q: What medical issue is ABIRATERONE - Group 2 most frequently administered for?

ABIRATERONE - Group 2 is most often used to treat <a href="https://www.withpower.com/clinical-trials/ulcerative-colitis">Ulcerative colitis</a>, but it has also been found effective in the management of Varicella-Zoster Virus Acute Retinal Necrosis, Brain and Iritis.

Phase 1

Waitlist Available

Led By HAN XU, MD/PhD/FAPCR

Research Sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Eligibility Criteria Checklist

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

Must have

Cervical HPV Infection Patients

Positive testing HPV by standard PCR assay

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 time per 180 days

Awards & highlights

9vHPV-BCG Trial Summary

This trial is testing a treatment that could potentially help COVID-19 patients by directly attacking the virus.

Who is the study for?

This trial is for individuals with cervical HPV infection confirmed by PCR, without symptoms or signs of cancer. Participants must have a negative PPD skin test (less than 5 mm swelling at 48 hours). It's not open to those allergic, critically ill, pregnant, showing thrombosis or oncology signs, or having symptoms/infections other than HPV.Check my eligibility

What is being tested?

The study tests a mix of the 9vHPV vaccine and BCG vaccine applied through the skin to see if it can treat multiple strains of HPV by training the immune system to better recognize and clear the virus.See study design

What are the potential side effects?

Potential side effects may include typical reactions at the injection site like redness and swelling, flu-like symptoms such as fever and fatigue, and possibly mild local skin reactions due to percutaneous administration.

9vHPV-BCG Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have an HPV infection in my cervix.

Select...

I tested positive for HPV.

Select...

I have HPV but no symptoms.

9vHPV-BCG Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 time per 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 time per 180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 time per 180 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

20 Participants with HPV testing by standard PCR assay

Secondary outcome measures

The Number of Participants with Adverse Events as a Measure of Safety

Other outcome measures

The Number of Participants with ABIRATERONE drug target gene SNPs associated to Adverse Events in Peripheral blood WBCs as a Measure of Safety

The Number of Participants with ABIRATERONE drug target gene SNPs associated to Effective Events in prostate cancer cells as a Measure of Efficacy

9vHPV-BCG Trial Design

1Treatment groups

Experimental Treatment

Group I: Assess for HPV Antigen Presentation Therapeutic Biological Product Mix activityExperimental Treatment1 Intervention

9vHPV Vaccine 1.0 mL add into BCG Organism 50 MG

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairLead Sponsor

5 Previous Clinical Trials

2,420 Total Patients Enrolled

Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB ChairLead Sponsor

3 Previous Clinical Trials

1,220 Total Patients Enrolled

PPDIndustry Sponsor

159 Previous Clinical Trials

36,895 Total Patients Enrolled

Media Library

ABIRATERONE - Group 1 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02403505 — Phase 1

Human Papillomavirus Research Study Groups: Assess for HPV Antigen Presentation Therapeutic Biological Product Mix activity

Human Papillomavirus Clinical Trial 2023: ABIRATERONE - Group 1 Highlights & Side Effects. Trial Name: NCT02403505 — Phase 1

ABIRATERONE - Group 1 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02403505 — Phase 1

Frequently Asked Questions

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

Who is eligible to partake in this clinical investigation?

"This medical trial seeks to evaluate the efficacy of a specific COVID-19 therapy and is recruiting 20 participants, aged between 24 and 74 years old. The inclusion criteria include patients that are mildly ill with no symptoms or mild illness such as fever, coughs, sore throat, fatigue etc., PPD negative results in skin test readings < 5mm induration at 48 hours, positive testing for COVID-19 by RT-PCR assay but without moderate/severe signs of infection."

Answered by AI

Is this trial open to individuals of advanced age?

"This medical trial requires applicants to be between 24 and 74 years of age. Conversely, 277 studies are available for those under 18 while 2502 exist for individuals older than 65."

Answered by AI

What is the aggregate figure of individuals participating in this clinical research endeavor?

"At the present moment, this clinical trial is not enrolling any new patients. It was initially published on December 28th of 2021 and its information was most recently updated in November 21st 2022. If you are looking for alternative research opportunities, there are 2283 trials studying COVID-19 currently recruiting participants and 429 studies examining ABIRATERONE - Group 2 seeking volunteers."

Answered by AI

Does this research program have any vacancies for participants?

"This trial is not currently recruiting. Having been first posted on December 28th 2021 and last updated on November 21st 2022, it has temporarily suspended patient recruitment. For those looking for other trials, there are 2,283 clinical studies enrolling patients with COVID-19 and 429 organisations seeking participants in the ABIRATERONE - Group 2 study group."

Answered by AI

Have any other experiments been conducted with ABIRATERONE - Group 2?

"Presently, 429 trials are underway evaluating the efficacy of ABIRATERONE - Group 2, with 129 studies at Phase 3. Most of these analyses are located in Gothenburg and Iowa; however there are over 20,000 sites running tests for this pharmaceutical agent."

Answered by AI

What medical issue is ABIRATERONE - Group 2 most frequently administered for?

"ABIRATERONE - Group 2 is most often used to treat Ulcerative colitis, but it has also been found effective in the management of Varicella-Zoster Virus Acute Retinal Necrosis, Brain and Iritis."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Gefitinib Plus Chemotherapy Versus Placebo Plus Chemotherapy in Egfr-mutation-positive Non-small-cell Lung Cancer After Progression on First-line Gefitinib (IMPRESS): A Phase 3 Randomised Trial

Soria, Jean-Charles, Yi-Long Wu, Kazuhiko Nakagawa, Sang-We Kim, Jin-Ji Yang, Myung-Ju Ahn, Jie Wang, et al.. 2015. “Gefitinib Plus Chemotherapy Versus Placebo Plus Chemotherapy in Egfr-mutation-positive Non-small-cell Lung Cancer After Progression on First-line Gefitinib (IMPRESS): A Phase 3 Randomised Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(15)00121-7.

clinicaltrials.govStudy

Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating HPV

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair 2021. "Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating HPV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02403505.