Healthy SubjectPhase 2NCT02382419
Carrageenan-Containing Gel in Reducing the Rate of HPV Infection in Healthy Participants
A Phase 2 study testing carrageenan-containing gel, Laboratory Biomarker Analysis and Questionnaire Administration in people with Healthy Subject and Human Papillomavirus Infection, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject, Human Papillomavirus Infection
- What is being tested?
- carrageenan-containing gel, Laboratory Biomarker Analysis and Questionnaire Administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2016to 13 Feb 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
About this study
Official title: Expanded Phase II Trial of a Carrageenan-Containing Gel for Prevention of HPV Infection
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To measure the overall efficacy of the intervention in reducing the rate of incident cervical HPV infection.
SECONDARY OBJECTIVES:
- Perform in vitro exploratory testing of how long after vaginal application the drug retains biological activity by collecting cervicovaginal lavage (CVL) at different times and spiking the samples with HPV pseudovirions (PsVs) and measuring PsV entry into target cells.
II. These studies will be expanded to test multiple HPV types and to examine whether the anti-HPV activity of the intervention is preserved in the setting of semen.
III. Store swabs to potentially test candidate biomarkers of microbicide efficacy and safety.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: 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.
ARM II: 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.
- Conditions
- Healthy Subject, Human Papillomavirus Infection
- Being tested
- carrageenan-containing gel, Placebo, Laboratory Biomarker Analysis, Questionnaire Administration
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carrageenan-containing gelDrug
Also called Divine 9 with Carragel
Applied vaginally
PlaceboOther
Also called PLCB
Applied vaginally
Laboratory Biomarker AnalysisOther
Correlative studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (4)
Cumulative incidence rates of HPV in the target population (using data from the placebo group)
Multivariate logistic regression models that incorporate additional subject data (e.g., frequency of intercourse and number of recent sex partners, anal sex, and smoking behavior) will be fit to the data to control for potential imbalances in subject characteristics that may occur despite randomization with HPV infection status as the binary dependent variable. A generalized estimating equation approach will also be used to model treatment effect on infection with multiple HPV types.
Measured: At 1 year
Subject adherence as measured by monthly applicator collection and counting
Will perform a per protocol analysis including only "adherent" subjects, defined as subjects who report gel use as recommended (within one hour of intercourse) in > 50% of all vaginal intercourse acts. Will perform additional analyses to identify any imbalances in subject characteristics across groups, and in secondary analyses using logistic regression models to incorporate this as above.
Measured: Up to 1 year
Behavioral characteristics assessed by questionnaires
Multivariate logistic regression models that incorporate additional subject data (e.g., frequency of intercourse and number of recent sex partners, anal sex, and smoking behavior) will be fit to the data to control for potential imbalances in subject characteristics that may occur despite randomization with HPV infection status as the binary dependent variable. A generalized estimating equation approach will also be used to model treatment effect on infection with multiple HPV types.
Measured: 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
Changes in this variable at each time point relative to baseline will be compared between groups using analysis of covariance models to adjust for baseline level. In addition, linear mixed effects models will be fit to all the repeated measurements to evaluate and compare trends over time while adjusting for the within-subject correlation in the data.
Measured: Baseline to up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study start24 Feb 2016
- Primary completion13 Feb 2019
- Study completion13 Feb 2019
Why it stopped: Principal Investigator Decided to stop recruitment in the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mark H. Einstein, MD, MS, FACS, FACOS, Rutgers, The State University of New Jersey
- Investigators
- Mark Einstein, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382419
- Sponsor's protocol ID
- 20150002694
- Other IDs
- NCI-2015-00209, 20150002694, R01CA148966, P30CA013330
- Status last verified
- Jul 2019
- First submitted
- 26 Feb 2015
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Phase II Trial of a Carrageenan-Containing Gel for Prevention of HPV Infection
- ClinicalTrials.gov ID
- NCT02382419
- Acronym / sponsor ID
- 20150002694
- Conditions
- Healthy Subject, Human Papillomavirus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator Decided to stop recruitment in the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Feb 2016 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To measure the overall efficacy of the intervention in reducing the rate of incident cervical HPV infection.
SECONDARY OBJECTIVES:
- Perform in vitro exploratory testing of how long after vaginal application the drug retains biological activity by collecting cervicovaginal lavage (CVL) at different times and spiking the samples with HPV pseudovirions (PsVs) and measuring PsV entry into target cells.
II. These studies will be expanded to test multiple HPV types and to examine whether the anti-HPV activity of the intervention is preserved in the setting of semen.
III. Store swabs to potentially test candidate biomarkers of microbicide efficacy and safety.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: 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.
ARM II: 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (carrageenan-containing gel) | Experimental | Drug: carrageenan-containing gel, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationParticipants 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. |
| Arm II (placebo gel) | Placebo comparator | Other: Placebo, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationParticipants 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. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- Prior use of an HPV vaccine
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carrageenan-containing gelAlso: Divine 9 with CarragelApplied vaginally | Drug | Arm I (carrageenan-containing gel) |
| PlaceboAlso: PLCBApplied vaginally | Other | Arm II (placebo gel) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (carrageenan-containing gel), Arm II (placebo gel) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (carrageenan-containing gel), Arm II (placebo gel) |
Primary outcome
Rate of incident cervical HPV infection
Time frame: Up to 1 year
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.
4 secondary outcomes
Cumulative incidence rates of HPV in the target population (using data from the placebo group)
Time frame: At 1 year
Subject adherence as measured by monthly applicator collection and counting
Time frame: Up to 1 year
Behavioral characteristics assessed by questionnaires
Time frame: 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
Time frame: Baseline to up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Einstein principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carrageenan-containing gel, Laboratory Biomarker Analysis and Questionnaire Administration in people with Healthy Subject and Human Papillomavirus Infection, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of incident cervical HPV infection (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.