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A Phase II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Females

Phase 2
13 Years
45 Years
Not Enrolling
HIV Infections, Sexually Transmitted Diseases

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Trial Information

A Phase II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Females

HPV is a DNA virus that affects both men and women. Approximately 90 types of HPV have been
identified, 30 of which are sexually transmitted. The most common forms of HPV are types 6,
11, 16, and 18. The quadrivalent HPV vaccine that will be tested in this study has been
shown in previous studies to be effective in preventing infection with HPV 6, 11, 16, and 18
in healthy young women. According to a report by the Centers for Disease Control and
Prevention (CDC), 80% of women will have acquired HPV by the age of 50. HIV infected women
have been reported to have a higher prevalence and persistence of HPV infection, as well as
an increased risk for abnormal Pap smears and cervical cancer. HPV types 16 and 18 cause the
majority of cervical cancers worldwide, and types 6 and 11 are responsible for the majority
of cases of genital warts. Vaccinations for preventable infections are particularly
important among HIV infected people because people with HIV have compromised immune systems;
therefore, any infection is very serious and can potentially be fatal. However, standard
vaccination series have not been very successful because a compromised immune system may not
produce the desired immune response to a vaccine. The HPV vaccine is designed to protect
against infection with HPV types 6, 11, 16, and 18 and has been approved by the FDA for use
in women between the ages of 9 and 26. The purpose of this study is to determine whether the
quadrivalent HPV vaccine is safe, tolerable, and effective in producing antibodies to HPV in
HIV infected females.

This study will last 72 weeks. Participants will receive their first dose of the HPV vaccine
by intramuscular injection. The HPV vaccine will be administered again at Weeks 8 and 24.
Following each injection, participants will remain at the clinic for 30 minutes of
observation for adverse events. A phone call from or a home visit by study staff will occur
within 2 days following each injection.

Participants will return to the clinic for visits at Weeks 4, 8, 12, 24, 28, 52, and 72.
Most study visits will include a physical exam, medication review, blood and urine
collection, and answering questions about signs and symptoms since study screening. Some
visits will include measurement of HIV viral load in the cervix, a cervical brush, an anal
swab, and an oral exam. Some participants will be asked to provide additional blood samples.

Inclusion Criteria:

- HIV infected

- CD4 count obtained within 45 days prior to study entry

- Willing to use acceptable forms of contraception for the duration of the study

- Written informed consent from parent or guardian, if applicable

Exclusion Criteria:

- Abnormal Pap test with confirmed biopsy results of cervical intraepithelial
neoplasia (CIN) II or III or cervical cancer within 180 days prior to study entry

- Vulval intraepithelial neoplasia (VIN) II or III or cancer confirmed by biopsy
results within 180 days prior to study entry

- Physician-diagnosed genital warts within 180 days prior to study entry

- Previous cervical dysplasia treatment, including loop electrosurgical excision
procedure (LEEP), cervical cryotherapy, cone biopsy, and cervical laser vaporization
within 180 days prior to study entry

- Use of any systemic antineoplastic or immunomodulatory treatment, systemic
corticosteroids, investigational vaccines, interleukins, interferons, growth factors,
or intravenous immunoglobulin (IVIG) within 45 days prior to study entry.
Participants who have received standard of care (e.g., hepatitis B, influenza, and
tetanus) vaccines are not excluded.

- Known allergy or hypersensitivity to yeast or any components of the vaccine or its

- Current drug or alcohol use or dependence or any other condition that may interfere
with study participation

- Serious illness requiring systemic treatment and/or hospitalization within 45 days
prior to study entry

- Total hysterectomy. Participants who have undergone partial hysterectomy and have a
cervix are not excluded.

- Hemophilia

- Currently on anticoagulation therapy other than aspirin

- Prior vaccination with an HPV vaccine

- Certain abnormal laboratory values

- Pregnant or breastfeeding

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Type-specific HPV antibody development from the seronegative status at baseline to seropositive status a month after the completion of HPV vaccination series (Week 28) for HPV types 6, 11, 16, and 18

Outcome Time Frame:

At Week 32

Safety Issue:


Principal Investigator

Erna Milunka Kojic, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Immunology/Infectious Disease, The Miriam Hospital, Brown University


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

November 2012

Related Keywords:

  • HIV Infections
  • Sexually Transmitted Diseases
  • HIV-1
  • HPV 6
  • HPV 11
  • HPV 16
  • HPV 18
  • Vaccine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sexually Transmitted Diseases



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