Preparedness Study: Efficacy of HPV Vaccine to Reduce HIV Infection
16 Years
24 Years
Female
Sexual Transmission of Infection
Trial Information
Preparedness Study: Efficacy of HPV Vaccine to Reduce HIV Infection
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Outcome Measure:
Number of Participants With Desired Effect
Outcome Description:
Evaluate the efficacy of HPV vaccination, a novel intervention, in the prevention of HIV infection among women residing in South Africa, a country among those with the highest HIV incidence rates internationally.
Outcome Time Frame:
18 Months
Safety Issue:
No
Principal Investigator
Anna Giuliano, Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Institutional Review Board
Study ID:
MCC-16685
NCT ID:
NCT01489527
Start Date:
September 2012
Completion Date:
February 2014
Related Keywords:
- Sexual Transmission of Infection
- Vaccine
- Placebo
- sexually transmitted infection (STI)
- HIV
- Human Immunodeficiency
- Gardasil
- HPV
- human papillomavirus
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
