Preparedness Study - HPV Vaccine

Not Applicable

Completed

Conditions: Sexual Transmission of Infection

Interventions: Other: Placebo
Biological: Gardasil Vaccine

Registration Number: NCT01489527

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 406

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Administration	Placebo	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.
Gardasil Vaccine Administration	Gardasil Vaccine	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.

Primary Outcome Measures

Name	Time	Method
Human Papillomavirus (HPV) Rate	At Enrollment - 5 Month Enrollment Period	HPV type distribution and prevalence of each HPV type at enrollment.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58	18 Months	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.
Study Compliance Rate	18 Months	Percentage of participants to complete the 3-dose vaccination series and all 4 study visits.
Percentage of Participants Who Were Seropositive by HPV Type	At Enrollment - 5 Month Enrollment Period	Percentage of participants who were seropositive to HPV at enrollment, by specific HPV type.
Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18	18 Months	Percentage of participants who seroconverted to HPV types 6, 11, 16, or 18, following receipt of 3 doses of qHPV vaccine.

Trial Locations

Locations (2): H. Lee Moffitt Cancer Center and Research Institute
🇺🇸
Tampa, Florida, United States
Stellenbosch University
🇿🇦
Parow, South Africa