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Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women
This study is currently recruiting participants.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), January 2009
Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00604175
  Purpose

Human papillomavirus (HPV) is the most common sexually transmitted disease in the world. HPV infection can cause genital warts and certain cervical problems, including cervical cancer. HPV infection may be more severe and harder to treat in HIV-infected people. 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 women.


Condition Intervention Phase
HIV Infections
Sexually Transmitted Diseases
Biological: Quadrivalent human papillomavirus vaccine
Phase II

MedlinePlus related topics: AIDS Sexually Transmitted Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Females

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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 [ Time Frame: At Week 32 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of Grade 3 or greater adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • HPV antibody titers to types 6, 11, 16, 18 [ Time Frame: At baseline and Weeks 4, 12, 28, and 52 ] [ Designated as safety issue: No ]
  • Longitudinal changes in HIV viral load and CD4 count from baseline [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Nadir and baseline CD4 count [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Baseline HIV viral load [ Time Frame: At Weeks 4, 8, 12, 24, 28, 52, and 72 ] [ Designated as safety issue: No ]
  • Cellular immune response assay data from the subset of U.S. participants [ Time Frame: At Weeks 4, 8, 12, 24, 28, 52, and 72 ] [ Designated as safety issue: No ]

Estimated Enrollment: 402
Study Start Date: April 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stratum A: Active Comparator
Participants with a CD4 count greater than 350 cells/mm3 will receive the quadrivalent HPV vaccine at study entry and Weeks 8 and 24.
Biological: Quadrivalent human papillomavirus vaccine
All groups will receive the vaccine via intramuscular injection
Stratum B: Active Comparator
Participants with a CD4 count between 200 and 350 cells/mm3 will receive the quadrivalent HPV vaccine at study entry and Weeks 8 and 24.
Biological: Quadrivalent human papillomavirus vaccine
All groups will receive the vaccine via intramuscular injection
Stratum C: Active Comparator
Participants with a CD4 count 200 cells/mm3 or less will receive the quadrivalent HPV vaccine at study entry and Weeks 8 and 24.
Biological: Quadrivalent human papillomavirus vaccine
All groups will receive the vaccine via intramuscular injection

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   13 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infected
  • CD4 count obtained within 45 days prior to study entry
  • HIV viral load levels obtained within 45 days prior to study entry by any laboratory that has CLIA certification or its equivalent
  • If receiving HAART, must be on the same HAART regimen for at least 12 weeks prior to study entry, with no change within 30 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:

  • Current (within 6 months prior to study entry) abnormal Pap test with confirmed biopsy results of cervical intraepithelial neoplasia (CIN) II or III or cervical cancer
  • History of CIN II or III or cancer confirmed by biopsy results.
  • Current (within 60 days prior to study entry) or history of vulval intraepithelial neoplasia (VIN) II or III or cancer confirmed by biopsy results
  • 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
  • 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 formulation
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604175

  Show 23 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: Erna Milunka Kojic, MD Department of Immunology/Infectious Disease, The Miriam Hospital, Brown University
Study Chair: Susan Cu-Uvin, MD Obstetrics-Gynecology and Medicine, The Miriam Hospital, Brown University
  More Information

Click here for more information about recommended immunizations for HIV infected adults  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: DAIDS ( Rona Siskind )
Study ID Numbers: ACTG A5240
Study First Received: January 17, 2008
Last Updated: January 7, 2009
ClinicalTrials.gov Identifier: NCT00604175  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV-1
HPV 6
HPV 11
HPV 16
HPV 18
Vaccine

Study placed in the following topic categories:
Genital Diseases, Female
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Genital Diseases, Male
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009