Sexual Transmission of Infection Clinical Trial
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.
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
| Status | Completed |
| Enrollment | 406 |
| Est. completion date | December 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 16 Years to 24 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| South Africa | Stellenbosch University | Parow | |
| United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Merck Sharp & Dohme Corp. |
United States, South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Human Papillomavirus (HPV) Rate | HPV type distribution and prevalence of each HPV type at enrollment. | At Enrollment - 5 Month Enrollment Period | No |
| Secondary | Study Compliance Rate | Percentage of participants to complete the 3-dose vaccination series and all 4 study visits. | 18 Months | No |
| Secondary | Percentage of Participants Who Were Seropositive by HPV Type | Percentage of participants who were seropositive to HPV at enrollment, by specific HPV type. | At Enrollment - 5 Month Enrollment Period | No |
| Secondary | 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. | 18 Months | No |
| Secondary | 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. | 18 Months | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01575938 -
HIV Prevention Intervention for Young Transgender Women
|
N/A |