Managing Infectious Vulvovaginitis for Precancerous Conditions of the Vulva

Overseen By Amanda Urban

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Virginia

Must not be taking: Antibiotics, Corticosteroids

Disqualifiers: Pregnancy, Immunosuppression, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

91 Participants Needed

Trial Summary

What is the purpose of this trial?

Primary: * To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision * To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease We will use a vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida. The swab will be collected preoperatively on day of surgery. The outcome will be evaluated by phone call to patient at 1 week after surgery and physical exam at the postoperative visit between 4-6 weeks.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used antibiotics recently (within the last 3 weeks or 5.5 times the half-life of the antibiotic). If you are on chronic treatment with corticosteroids or other immunosuppressive agents, you may not be eligible to participate.

What data supports the effectiveness of the treatment Vaginitis Panel, Vaginitis Test, Vulvovaginal Swab, Vaginal Infection Panel for managing infectious vulvovaginitis?

Research shows that molecular tests like the Affirm VPIII are more sensitive in detecting infections such as bacterial vaginosis, Candida, and Trichomonas compared to traditional methods, which suggests that using these tests can improve the accuracy of diagnosing and managing vulvovaginitis. ^{1 2 3 4 5}

Is the treatment for managing infectious vulvovaginitis safe for humans?

The safety data available is for HPV vaccines, which are generally well tolerated in humans. Common side effects include pain at the injection site, swelling, and fever, but no serious adverse events were observed in the studies. ^{6 7 8 9 10}

How does the Vaginitis Panel treatment differ from other treatments for infectious vulvovaginitis?

The Vaginitis Panel treatment is unique because it uses a molecular test to accurately identify the specific organisms causing the infection, such as bacterial vaginosis, vulvovaginal candidiasis, and Trichomonas vaginalis, which helps in guiding precise treatment. This approach is more accurate than traditional methods, improving diagnosis and potentially leading to better-targeted therapies. ^{1 2 4 11 12}

Eligibility Criteria

This trial is for adults with non-cancerous vulvar conditions needing surgery in central VA. Participants must not be pregnant, recently on antibiotics, have a history of cancer treatments within 3 years, or have immune system issues. They should be able to consent and not have uncontrolled diabetes or severe infections.

Inclusion Criteria

I am scheduled for a lumpectomy or partial mastectomy.

You have provided written consent to proceed with any procedures required for the protocol.

My vulvar condition is confirmed not to be cancer.

Exclusion Criteria

I am unable to understand and agree to the study's procedures and risks.

I am not pregnant or nursing.

I haven't taken antibiotics in the last 3 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Testing

Vulvovaginal swab collected preoperatively on the day of surgery to test for bacterial vaginosis, trichomonas, and candida

1 day

1 visit (in-person)

Postoperative Follow-up

Outcome evaluated by phone call at 1 week after surgery and physical exam at postoperative visit between 4-6 weeks

6 weeks

1 phone call, 1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Vaginitis Panel

Trial Overview The study aims to measure the rate of infectious vulvovaginitis and its correlation with wound complications after surgical excision for premalignant lesions. Patients will be swabbed preoperatively to test for common causes like BV, trichomonas, and candida.

Participant Groups

Group I: Positive Perioperative Vaginitis Experimental Treatment 1 Intervention

Participants who test positive for BV, candida, and/or trichomonas on perioperative vaginitis swab.

Vaginitis Panel is already approved in United States, European Union for the following indications:

Approved in United States as Vaginitis Panel for:

• Diagnosis of bacterial vaginosis (BV)
• Diagnosis of trichomonas
• Diagnosis of candida

Approved in European Union as Vaginitis Panel for:

• Diagnosis of vaginal infections
• Screening for sexually transmitted infections

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Findings from Research

In a study of 489 participants, the vaginal panel assay showed significantly better diagnostic accuracy for bacterial vaginosis and Trichomonas vaginalis compared to clinical assessments, with positive agreement rates of 57.9% and 28.0%, respectively.

The clinical diagnosis missed a substantial number of cases, with 65% of bacterial vaginosis and 44% of vulvovaginal candidiasis cases identified by the assay going untreated due to negative clinical diagnoses, highlighting the potential of the assay to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a Vaginal Panel Assay Compared With the Clinical Diagnosis of Vaginitis. Broache, M., Cammarata, CL., Stonebraker, E., et al.[2022]

Women diagnosed with vulvovaginitis using amplified molecular probe testing (AMP) had significantly lower healthcare utilization and costs compared to those diagnosed with non-amplified molecular probe testing (NAMP), with fewer outpatient visits and lower prescription medication use.

Among pregnant women, AMP testing was associated with a 12% reduction in the risk of preterm labor or delivery, highlighting its potential to improve health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health care utilization and costs following amplified versus non-amplified molecular probe testing for symptomatic patients with suspected vulvovaginitis: a US commercial payer population. Ackerman, SJ., Knight, T., Wahl, PM., et al.[2022]

The Affirm VPIII Microbial Identification Test demonstrated comparable detection rates for Gardnerella and Candida infections when compared to standard diagnostic methods, with sensitivity of 75.0% for Gardnerella and 82.76% for Candida.

This test offers a rapid diagnostic option for physicians treating vulvovaginitis, allowing for timely diagnosis and treatment at the point of care, which is particularly beneficial for the 195 women studied, most of whom were symptomatic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Affirm VPIII microbial identification test can be used to detect gardnerella vaginalis, Candida albicans and trichomonas vaginalis microbial infections in Korean women. Byun, SW., Park, YJ., Hur, SY.[2020]

The Affirm VPIII molecular test was found to be significantly more sensitive than the routine Pap test in detecting Candida species, Trichomonas vaginalis, and Gardnerella vaginalis in a study of 431 women aged 17 to 79.

While the Pap test identified 13.9% of patients with bacterial vaginosis and candidiasis, the Affirm VPIII assay detected 42.5% for Gardnerella, 16.2% for Candida, and 2.3% for Trichomonas, highlighting its superior diagnostic capability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Affirm VPIII and Papanicolaou tests in the detection of infectious vaginitis. Levi, AW., Harigopal, M., Hui, P., et al.[2013]

In a study of 347 women in India, bacterial vaginosis (BV) was found to have a prevalence of 45.1%, highlighting a significant public health concern in reproductive-age women.

The OSOM BVBlue test showed good specificity (92.7%) but poor sensitivity (38.1%) compared to the Nugent score, indicating that while it can accurately identify those without BV, it may miss many cases, suggesting a need for improved diagnostic methods in resource-poor settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of BVBlue rapid test in detecting bacterial vaginosis among women in Mysore, India. Madhivanan, P., Krupp, K., Li, T., et al.[2021]

The post-licensure safety profile of HPV vaccines Gardasil and Cervarix was evaluated using data from three sources, including VigiBase and VAERS, confirming that the reported adverse events align with existing safety data.

The analysis showed that the safety profiles of both vaccines are consistent with the information provided in their Summary of Product Characteristics (SPC), indicating that they are safe for public use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. Labadie, J.[2015]

In a study of 271 women aged 25, the HPV-16/18 AS04-adjuvated vaccine was found to be safe, with no severe adverse events reported, and the most common side effects were injection site pain (83.4%), local swelling (20.8%), and fever (14.6%).

The safety profile of the vaccine in adult women was similar to that observed in preadolescent girls, although adults reported higher frequencies of fever and local pain, indicating that while the vaccine is generally well-tolerated, adults may experience slightly more discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of bivalent human papillomavirus (HPV) vaccine safety and tolerability in a sample of 25 year old Tuscan women. Levi, M., Bonanni, P., Burroni, E., et al.[2022]

Genital HPV infection is the most common sexually transmitted infection, contributing to nearly all cervical cancers and a significant number of other anogenital and oropharyngeal cancers, highlighting the importance of prevention through vaccination.

Two effective prophylactic HPV vaccines, Gardasil and Cervarix, induce protective immunity and are most effective when administered before sexual activity, significantly reducing the risk of HPV-related cancers and diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papilloma virus vaccines: Current scenario. Pandhi, D., Sonthalia, S.[2022]

A study involving 4,643 participants evaluated the safety and tolerability of the Cervarix vaccine in Italy, finding no serious adverse events and mostly mild reactions such as pain at the injection site and fatigue.

The vaccine demonstrated better tolerability compared to some clinical studies, with most reactions being of negligible intensity and duration, suggesting that real-world vaccination experiences may differ from controlled trial settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of bivalent HPV vaccine: an Italian post-licensure study. Gasparini, R., Bonanni, P., Levi, M., et al.[2019]

Cervarix, a vaccine targeting HPV types 16 and 18, demonstrated high efficacy in preventing high-grade cervical lesions and cervical cancer in over 19,000 women aged 15-25, with a follow-up of at least 5.5 years.

The vaccine induced a stronger immune response in younger girls (10-14 years) compared to older women (26-55 years), and was generally well tolerated, with injection-site reactions being the most common side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus types 16 and 18 vaccine (recombinant, AS04 adjuvanted, adsorbed) [Cervarix]. Keam, SJ., Harper, DM.[2021]

The Xpert Xpress MVP test showed high accuracy in diagnosing vaginitis/vaginosis, with positive agreement rates between 93.6% and 99.0% and negative agreement rates between 92.1% and 99.8% for both clinician-collected and self-collected samples.

Conducted across 12 diverse clinical sites in the U.S., this study suggests that the MVP test could be a reliable diagnostic tool in both laboratory and point-of-care settings for patients with symptoms of vaginitis/vaginosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of a New Molecular Test for the Detection of Organisms Causing Vaginitis and Vaginosis. Lillis, RA., Parker, RL., Ackerman, R., et al.[2023]

The BD Affirm VPIII test showed lower sensitivity and specificity compared to nucleic acid amplification (NAA) tests for diagnosing bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC), with BV-PCR achieving 96.9% sensitivity and 92.6% specificity, while Affirm VPIII had 90.1% sensitivity and 67.6% specificity.

For trichomoniasis, the GenProbe Aptima test demonstrated significantly higher sensitivity (98.1%) compared to Affirm VPIII (46.3%), indicating that NAA tests are generally more reliable for diagnosing vaginitis than the nonamplified BD Affirm VPIII system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of nucleic acid amplification assays with BD affirm VPIII for diagnosis of vaginitis in symptomatic women. Cartwright, CP., Lembke, BD., Ramachandran, K., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Performance of a Vaginal Panel Assay Compared With the Clinical Diagnosis of Vaginitis. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Health care utilization and costs following amplified versus non-amplified molecular probe testing for symptomatic patients with suspected vulvovaginitis: a US commercial payer population. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Affirm VPIII microbial identification test can be used to detect gardnerella vaginalis, Candida albicans and trichomonas vaginalis microbial infections in Korean women. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Comparison of Affirm VPIII and Papanicolaou tests in the detection of infectious vaginitis. [2013]

5. Egypt pubmed.ncbi.nlm.nih.gov

Performance of BVBlue rapid test in detecting bacterial vaginosis among women in Mysore, India. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of bivalent human papillomavirus (HPV) vaccine safety and tolerability in a sample of 25 year old Tuscan women. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Human papilloma virus vaccines: Current scenario. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of bivalent HPV vaccine: an Italian post-licensure study. [2019]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Human papillomavirus types 16 and 18 vaccine (recombinant, AS04 adjuvanted, adsorbed) [Cervarix]. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of a New Molecular Test for the Detection of Organisms Causing Vaginitis and Vaginosis. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Comparison of nucleic acid amplification assays with BD affirm VPIII for diagnosis of vaginitis in symptomatic women. [2022]