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Sexual Transmission of InfectionNCT01489527

Preparedness Study - HPV Vaccine

A study testing Gardasil Vaccine in people with Sexual Transmission of Infection, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Moffitt Cancer Center is the Coordinating Center for this study. The purpose of this study is to develop and test the infrastructure to conduct a future Phase III vaccine efficacy trial to assess trial feasibility, and to assess human papillomavirus (HPV) genotype distribution, data needed to design a Phase III trial. Read more about this study

Who is it for?
Ages 16 to 24 years, women onlyHealthy volunteers can take part
Conditions the study is for
Sexual Transmission of Infection
What is being tested?
Gardasil Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
406 participants
Where
2 sitesin 2 countries
Study dates
Sep 2012to Dec 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 16 to 24 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Women ages 16-24 years of age residing in a region of South Africa with a high HIV incidence and prevalence
  • HIV negative
  • has ever had vaginal intercourse
  • has never had Papanicolaou smear (Pap) testing or has only had normal Pap test results
  • fully understands study procedures, risks involved in the study, and voluntarily agrees to participate by giving written informed consent
  • agrees to refrain from douching/vaginal cleansing and using vaginal medications or preparations for 2 calendar days prior to the Day 1 visit as well as other future visits that include collection of cervical specimens
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  • agrees to refrain from sexual intercourse for 2 calendar days prior to the Day 1 visit as well as other future visits that include collection of cervical specimens
  • agrees to utilize effective contraception during sexual intercourse (excluding the rhythm method, withdrawal alone, and emergency contraception) during the vaccination period.
  • Informed consent procedures for females <18 years of age: Informed consent and informed assent will be obtained from parents/legal guardians and adolescents respectively, prior to participation. The consent form will include information about the study and individual request for consent of participants to participate in the study. It will be emphasized that participation is voluntary and that participants are free to withdraw from the study at any stage without any disadvantage to them. An assessment of understanding will be conducted at screening to ensure that consent is informed.

Who cannot join

  • have a history of severe allergic reaction
  • have a known allergy to any vaccine component (e.g., aluminum, yeast, or BENZONASE)
  • are currently immuno-compromised
  • have received a marketed HPV vaccine, or are pregnant and lactating

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

South Africa1 site

  • Stellenbosch University

    Parow, South Africa, 7505

Other trials in South Africa

About this study

Official title: Preparedness Study: Efficacy of HPV Vaccine to Reduce HIV Infection

Moffitt Cancer Center is the Coordinating Center for this study.

The purpose of this study is to develop and test the infrastructure to conduct a future Phase III vaccine efficacy trial to assess trial feasibility, and to assess human papillomavirus (HPV) genotype distribution, data needed to design a Phase III trial. The investigators propose to conduct a Preparedness study among women ages 16-24 years of age residing in a region of South Africa with a high human immunodeficiency (HIV) incidence and prevalence.

Read more

The specific aims of this study are to:

  1. Identify, recruit, enroll, and randomize a cohort of HIV negative women (200 per arm, 400 total) ages 16-24 years to an HPV vaccine against 4 types (HPV 6, 11, 16, 18 [Gardasil]) or placebo vaccine.
  2. Determine the cervical HPV prevalence and type distribution at enrollment, and cervical lesion prevalence among young females ages 16-24 years at high risk for HIV infection.
  3. Assess the rate of compliance through the 3-dose vaccination series
Read the detailed description

The study vaccine will be blindly administered as supplied on Day 1, Month 2, and Month 6. Both HPV and placebo vaccines will be in identical bottles, and all treatment codes will be kept under lock and key. All vaccines will be injected intramuscularly into the deltoid muscle by a member of the clinical staff. Each participant will be monitored for systemic and local reactions for 30 minutes postvaccination after each study vaccination for any adverse effects, including allergic reactions. Vaccine adverse events will continue to be monitored throughout the duration of the study period. Vaccine will be shipped to a central pharmacy at Stellenbosch University and stored in a refrigerator monitored and maintained at 2-8 C prior to distribution and local storage at participating clinical centers.

Being tested
Gardasil Vaccine, Placebo
Keywords
Vaccine, Placebo, sexually transmitted infection (STI), HIV, Human Immunodeficiency, Gardasil, HPV, human papillomavirus
Medical subject headings
Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gardasil VaccineBiological

    Also called Gardasil

    The study vaccine was blindly administered as supplied on Day 1, Month 2, and Month 6. All vaccines were injected intramuscularly into the deltoid muscle by a member of the clinical staff.

  • PlaceboOther

    The study vaccine was blindly administered as supplied on Day 1, Month 2, and Month 6. All vaccines were injected intramuscularly into the deltoid muscle by a member of the clinical staff.

Study groups in NCT01489527
Study groupRoleWhat they receive
Gardasil Vaccine AdministrationActive comparatorGardasil Vaccine Administration. Family Health International (FHI) statisticians randomly assigned each participant an allocation number and then subsequently assigned a unique vial identification number for the vial of vaccine the participant should receive at each visit. A single participant could not be assigned more than 1 allocation number.
Receives: Biological: Gardasil Vaccine
Placebo AdministrationPlacebo comparatorPlacebo Administration. Family Health International (FHI) statisticians randomly assigned each participant an allocation number and then subsequently assigned a unique vial identification number for the vial of vaccine the participant should receive at each visit. A single participant could not be assigned more than 1 allocation number.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Human Papillomavirus (HPV) Rate

    HPV type distribution and prevalence of each HPV type at enrollment.

    Measured: At Enrollment - 5 Month Enrollment Period

Secondary outcomes (4)

  1. Study Compliance Rate

    Percentage of participants to complete the 3-dose vaccination series and all 4 study visits.

    Measured: 18 Months

  2. Percentage of Participants Who Were Seropositive by HPV Type

    Percentage of participants who were seropositive to HPV at enrollment, by specific HPV type.

    Measured: At Enrollment - 5 Month Enrollment Period

  3. Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18

    Percentage of participants who seroconverted to HPV types 6, 11, 16, or 18, following receipt of 3 doses of qHPV vaccine.

    Measured: 18 Months

  4. Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58

    The percent of women that seroconverted among those receiving qHPV vaccine compared to placebo vaccine recipients for HPV types 31, 33, 45, and 58, HPV types not directly targeted by the qHPV vaccine.

    Measured: 18 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2011 (estimated)
  2. Study startSep 2012
  3. Primary completionApr 2014
  4. Study completionDec 2014

Resources

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01489527
Sponsor's protocol ID
MCC-16685
Other IDs
IISP ID 39582
Status last verified
Jan 2015
First submitted
8 Dec 2011
Last updated
6 Feb 2015
Data monitoring committee
Yes

Publications

  • Menezes LJ, Pokharel U, Sudenga SL, Botha MH, Zeier M, Abrahamsen ME, Glashoff RH, Engelbrecht S, Schim van der Loeff MF, van der Laan LE, Kipping S, Taylor D, Giuliano AR. Patterns of prevalent HPV and STI co-infections and associated factors among HIV-negative young Western Cape, South African women: the EVRI trial. Sex Transm Infect. 2018 Feb;94(1):55-61. doi: 10.1136/sextrans-2016-053046. Epub 2017 May 10.

    PubMed 28490581

  • Sudenga SL, Torres BN, Botha MH, Zeier M, Abrahamsen ME, Glashoff RH, Engelbrecht S, Schim Van der Loeff MF, Van der Laan LE, Kipping S, Taylor D, Giuliano AR. HPV SEROSTATUS PRE- AND POST-VACCINATION IN A RANDOMIZED PHASE II PREPAREDNESS TRIAL AMONG YOUNG WESTERN CAPE, SOUTH AFRICAN WOMEN: THE EVRI TRIAL. Papillomavirus Res. 2017 Jun;3:50-56. doi: 10.1016/j.pvr.2017.02.001. Epub 2017 Feb 16.

    PubMed 28480334

Questions about this trial

What is this clinical trial studying?

A study testing Gardasil Vaccine in people with Sexual Transmission of Infection, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in 2 countries.

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 9 inclusion and 4 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: finished, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, South Africa. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Human Papillomavirus (HPV) Rate (time frame: At Enrollment - 5 Month Enrollment Period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01489527, which also lists 2 linked publications.

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 6 Feb 2015.

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