Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Phase II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Females |
- 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 ]
- 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 8, 24, 28, 52, and 72 ] [ Designated as safety issue: No ]
- Longitudinal changes in HIV viral load [ Time Frame: Measured at Weeks 4, 12, 28, 52, and 72 ] [ 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 ]
- Longitudinal changes in CD4+ cell count from baseline [ Time Frame: Measured at Weeks 4, 8, 12, 24, 28, 52, and 72 ] [ Designated as safety issue: No ]
| Enrollment: | 320 |
| Study Start Date: | February 2008 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Stratum A
Participants with a CD4 count greater than 350 cells/mm3 will receive the quadrivalent HPV vaccine at study entry and Weeks 8 and 24. As of October 6, 2010, Stratum A is closed to accrual. |
Biological: Quadrivalent human papillomavirus vaccine
All groups will receive the vaccine via intramuscular injection
Other Name: GARDASIL
|
|
Active Comparator: Stratum B
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
Other Name: GARDASIL
|
|
Active Comparator: Stratum C
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
Other Name: GARDASIL
|
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 |
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 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
Show 61 Study Locations| 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
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00604175 History of Changes |
| Other Study ID Numbers: | A5240, 10393, ACTG A5240 |
| Study First Received: | January 17, 2008 |
| Last Updated: | February 10, 2013 |
| 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 |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Infection Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on March 10, 2013
