Preparedness Study - HPV Vaccine

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Sexual Transmission of Infection

Treatments: Other: Placebo; Biological: Gardasil Vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01489527

MCC-16685

IISP ID 39582 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 406 patients

Sex: Female

Ages: 16 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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406 participants in 2 patient groups, including a placebo group

Gardasil Vaccine Administration

Active Comparator group

Description:

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.

Treatment:

Biological: Gardasil Vaccine

Placebo Administration

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo