Carrageenan-Containing Gel in Reducing the Rate of HPV Infection in Healthy Participants

NCT02382419 | Withdrawn Phase 2 DMC

• 4 other identifiers: 20150002694NCI-2015-00209R01CA148966P30CA013330
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase II trial studies how well carrageenan-containing gel (vaginal gel) works in reducing the rate of human papilloma virus (HPV) infection in healthy participants. Carrageenans, which are naturally derived from seaweed, are enhancements to natural lubrication and may be effective in blocking HPV infection.

Conditions

Healthy Subject; Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (1)

• Rate of incident cervical HPV infection

  The primary analysis will be based upon the intent to treat approach. The cumulative incidence of HPV infection for each treatment group will be estimated as described above and the percent reduction in incidence due to intervention will be computed along with the corresponding one-sided 80% lower confidence bound.

  Up to 1 year

Secondary Outcomes (4)

• Cumulative incidence rates of HPV in the target population (using data from the placebo group)

  At 1 year

• Subject adherence as measured by monthly applicator collection and counting

  Up to 1 year

• Behavioral characteristics assessed by questionnaires

  Up to 1 year

• Biological activity of carrageenan-containing gel or placebo as measured by CVL at different times and spiking the samples with HPV PsVs and measuring PsV entry into target cells

  Baseline to up to 12 months

Study Arms (2)

Arm I (carrageenan-containing gel)

EXPERIMENTAL

Participants apply carrageenan-containing gel vaginally within 12 hours prior to each vaginal sex act and as soon as possible within 12 hours after each vaginal sex act and use condoms for 12 months.

Drug: carrageenan-containing gel; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Arm II (placebo gel)

PLACEBO COMPARATOR

Participants apply placebo gel vaginally within 12 hours prior to each vaginal sex act and as soon as possible within 12 hours after each vaginal sex act and use condoms for 12 months.

Other: Placebo; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Interventions

carrageenan-containing gel DRUG

Applied vaginally

Also known as: Divine 9 with Carragel

Arm I (carrageenan-containing gel)

Placebo OTHER

Applied vaginally

Also known as: PLCB

Arm II (placebo gel)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (carrageenan-containing gel); Arm II (placebo gel)

Questionnaire Administration OTHER

Ancillary studies

Arm I (carrageenan-containing gel); Arm II (placebo gel)

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sexually active women of all ethnicities and races with an intact cervix are eligible for this trial
• Engaging in three or more intercourse events (defined as having penile-vaginal intercourse) per month; subjects must consent not to douche or use any vaginal products, including tampons, for 24 hours before enrollment and study visits
• Normal Pap or Atypical Squamous Cells of Undetermined Significance (ASCUS) Pap test with HPV deoxyribonucleic acid (DNA) negative by reflex testing via Hybrid Capture 2 (Digene Corp., Gaithersburg, MD), a standard clinical assay within clinically acceptable screening guidelines (American Cancer Society \[ACS\]/American Society for Colposcopy and Cervical Pathology \[ASCCP\] 2012 Screening Guidelines)
• Using an adequate method of contraception for at least 3 months with no changes and will remain on the contraception for the duration of the trial; an adequate method of contraception is defined as either a hormonal based method (except vaginal rings); an intrauterine device (IUD) (inserted at least 30 days prior to enrollment); female sterilization; or sexual activity with a partner who had a vasectomy
• Speaks either English or Spanish, living in or near Newark with no plans to move in the next year, able to sign consent and complete questionnaires with aid of trained personnel

You may not qualify if:

• Prior use of an HPV vaccine
• Women in the vaccine-eligible age range cannot have received vaccine prior to enrollment, but will be offered HPV vaccination at the end of the study; in brief, we are interested in the efficacy of intervention in preventing HPV in the absence of HPV vaccination, since most women worldwide who might utilize intervention will not have been vaccinated; this includes United States (US) women in the vaccine "catch-up" 19-26 year old age group (beyond the age groups eligible for Vaccines for Children- funded vaccination) who have so far had very low (\< 10%) vaccine uptake; it also includes the entire group of US women \> 26 years of age; moreover, it includes women of all ages in developing countries, who most need an HPV prevention strategy, but may never be vaccinated; it should be noted that delaying vaccination in women 19-26 years of age by one year is safe and reasonable, since there is insufficient data to establish a recommendation for or against universal vaccination in this age group as concluded by an American Cancer Society expert panel, which includes the Principal Investigator (PI) of this protocol, Dr. Mark Einstein; it is anticipated that if the intervention gel is efficacious, HPV vaccinated women would need to be studied in a similar future trial with power analysis taking into account vaccine effectiveness as well
• Any previous surgical excision of cervical intraepithelial neoplasia (CIN) or hysterectomy
• A serious, concomitant disorder, including active systemic infection requiring treatment
• Prior history of or current malignancy other than adequately treated skin cancer (squamous cell cancer or basal cell carcinoma)
• Documented or suspected immunosuppressive disorder or autoimmune disease
• Any significant cardiac, hepatic or renal disease
• Pregnant and/or breast-feeding
• Recent (within 4 weeks of screening) or concomitant long term treatment with systemic steroids, immunosuppressive/immunomodulating drugs (e.g. cyclosporine, corticosteroids)
• Intranasal, inhaled and/or topical steroids are permissible
• Documented human immunodeficiency virus (HIV) infection, genital warts, chancroid, or pelvic inflammatory disease that will require long term treatment
• Active genital ulcers
• Use of an investigational drug in the 3 months prior to screening and must agree to not participate in any drug or device study while enrolled in this study
• Any known allergy or hypersensitivity to vaginal lubricants or any component of study product

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Einstein

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair Department of Obstetrics, Gynecology and Women's Health, Assistant Dean, Clinical Research Unit

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 6, 2015
• Study Start: February 24, 2016
• Primary Completion: February 13, 2019
• Study Completion: February 13, 2019
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

US (1)