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CompletedNCT01489527Updated Feb 6, 2015Results posted

Preparedness Study - HPV Vaccine

An interventional study of Gardasil Vaccine and Placebo in Sexual Transmission of Infection, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 2 sites in 2 countries. Open to female participants aged 16 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-06.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
406
Allocation
Randomized
Ages
16 Years to 24 Years
Sex
Female
01

Study 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. 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.

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.

02

Conditions studied

  • Sexual Transmission of Infection

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Keywords

  • Vaccine
  • Placebo
  • sexually transmitted infection (STI)
  • HIV
  • Human Immunodeficiency
  • Gardasil
  • HPV
  • human papillomavirus
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 406 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 24 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
406 participants (actual)

Study arms

  • Active comparator
    Gardasil Vaccine Administration

    Gardasil 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.

    Biological: Gardasil Vaccine

  • Placebo comparator
    Placebo Administration

    Placebo 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.

    Other: Placebo

Interventions

  • BiologicalGardasil Vaccine

    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.

    Also known as: Gardasil

  • OtherPlacebo

    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.

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What researchers measure

Primary outcomes

  1. Human Papillomavirus (HPV) Rate

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

    Time frame: At Enrollment - 5 Month Enrollment Period

Secondary outcomes

  1. Study Compliance Rate

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 18 Months

07

Results

Posted Jan 12, 2015
Limitations and caveats
The EVRI Trial had a short duration with limited follow-up time; therefore, clinical efficacy in reducing HIV acquisition cannot be assessed.

Participant flow

Women residing in the Western Cape, South Africa were enrolled from November 2012 to July 2013 in a preparedness study. Participants were recruited from the Kraaifontein day hospital and the Bloekombos primary health care clinic by community workers and through word of mouth, flyers, and brochures.

Participant flow — Overall Study
MilestoneGardasil Vaccine AdministrationPlacebo Administration
Started205201
Completed183175
Not completed2226
Withdrew: Pregnancy914
Withdrew: Participant moved67
Withdrew: Withdrawal by subject04
Withdrew: Lost to follow-up51
Withdrew: Procedures10
Withdrew: Not compliant10

Outcome measures

PrimaryHuman Papillomavirus (HPV) Rate

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

Time frame:
At Enrollment - 5 Month Enrollment Period
Reported as:
Number · participants
Human Papillomavirus (HPV) Rate
participantsGardasil Vaccine AdministrationPlacebo Administration
Any HPV Type143136
Any High-Risk Type106113
Any Low-Risk Type10397
HPV693
HPV1122
HPV162332
HPV181114
SecondaryStudy Compliance Rate

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

Time frame:
18 Months
Reported as:
Number · percentage of participants
Study Compliance Rate
percentage of participantsGardasil Vaccine AdministrationPlacebo Administration
Study Compliance Rate91.587.5
SecondaryPercentage of Participants Who Were Seropositive by HPV Type

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

Time frame:
At Enrollment - 5 Month Enrollment Period
Reported as:
Number · percentage of participants
Percentage of Participants Who Were Seropositive by HPV Type
percentage of participantsGardasil Vaccine AdministrationPlacebo Administration
HPV67373
HPV114547
HPV163237
HPV184641
HPV313138
HPV332530
HPV451518
HPV523635
HPV583636
SecondaryPercentage 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.

Time frame:
18 Months
Reported as:
Number · percentage of participants
Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18
percentage of participantsGardasil Vaccine AdministrationPlacebo Administration
Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18100—
SecondaryPercentage 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.

Time frame:
18 Months
Reported as:
Number · percentage of participants
Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58
percentage of participantsGardasil Vaccine AdministrationPlacebo Administration
HPV318239
HPV335634
HPV454219
HPV586938

Adverse events

Collected over 1 year, 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Gardasil Vaccine Administration—0/202 (0%)59/202 (29.2%)
Placebo Administration—0/200 (0%)62/200 (31%)
Most frequent other events
Showing 10 of 45
Most frequent other events
EventGardasil Vaccine AdministrationPlacebo Administration
Vaginal infectionInfections and infestations18/20216/200
PainGeneral disorders16/2025/200
Urinary tract infectionInfections and infestations7/20212/200
DizzinessNervous system disorders6/2024/200
HeadacheNervous system disorders1/2025/200
Vaginal dischargeReproductive system and breast disorders3/2025/200
LethargyNervous system disorders4/2020/200
Reproductive system and breast disorders - OtherReproductive system and breast disorders1/2023/200
Allergic rhinitisRespiratory, thoracic and mediastinal disorders0/2023/200
Flu like symptomsGeneral disorders3/2022/200

Baseline characteristics

All treated participants

Age, Continuous
Age, Continuous(years)Gardasil Vaccine AdministrationPlacebo AdministrationTotal
Median20 (16 to 24)20 (16 to 24)20 (16 to 24)
Age, Categorical
Age, Categorical(Participants)Gardasil Vaccine AdministrationPlacebo AdministrationTotal
<=18 years404686
Between 18 and 65 years162154316
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Gardasil Vaccine AdministrationPlacebo AdministrationTotal
Female202200402
Male000
Region of Enrollment
Region of Enrollment(participants)Gardasil Vaccine AdministrationPlacebo AdministrationTotal
South Africa202200402
08

Study locations

2 sites
  • H. Lee Moffitt Cancer Center and Research Institute
    Tampa, Florida 33612, United States
  • Stellenbosch University
    Parow, 7505, South Africa
09

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01489527
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Dec 9, 2011
Start date
Sep 2012
Primary completion
Apr 2014
Completion
Dec 2014
Results posted
Jan 12, 2015
Last update
Feb 6, 2015

Study contacts

Anna Giuliano, Ph.D.
principal investigator · H. Lee Moffitt Cancer Center and Research Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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