Clinical trial NCT01489527: Preparedness Study - HPV Vaccine
Official title: Preparedness Study: Efficacy of HPV Vaccine to Reduce HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Transmission of Infection
Keywords: Vaccine
Placebo
sexually transmitted infection (STI)
HIV
Human Immunodeficiency
Gardasil
HPV
human papillomavirus
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-12-09
Enrollment: 406
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Human Papillomavirus (HPV) Rate
timeFrame: At Enrollment - 5 Month Enrollment Period
Secondary outcomes:
measure: Study Compliance Rate
timeFrame: 18 Months
measure: Percentage of Participants Who Were Seropositive by HPV Type
timeFrame: At Enrollment - 5 Month Enrollment Period
measure: Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18
timeFrame: 18 Months
measure: Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58
timeFrame: 18 Months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Parow
country: South Africa
facility: Stellenbosch University
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Anna Giuliano, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.