Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women

Completed · Phase 2

Conditions studied: HIV Infections, Sexually Transmitted Diseases

In brief

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 was to determine whether the quadrivalent HPV vaccine is safe, tolerable, and effective in producing antibodies to HPV in HIV-infected women.

Key facts

Study ID

NCT00604175

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

319

Starts

2008-02-01

Expected to finish

2012-11-01

Last updated by the study team

2021-11-04

Who can join

Age: 13 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• HIV infection
• CD4 count obtained within 45 days prior to study entry
• Karnofsky performance score >=70 on at least one occasion within 45 days prior to study entry
• The following labs within 45 days prior to study entry:
• hemoglobin >8.0 g/dL
• direct bilirubin <2.5 x upper limit of normal (ULN)
• alanine aminotransferase, ALT (SGPT) <3 xULN
• aspartate aminotransferase, AST (SGOT) <3 xULN
• platelet count >=100,000 /mm\^3
• Willing to use acceptable forms of contraception for the duration of the study
• Written informed consent from participant or from parent or guardian, if applicable
• If on HAART, then the same regimen for at least 12 weeks prior to study entry with no change within 30 days prior to study entry. (This criterion was removed in Version 2.0 of the protocol.)
• HIV viral load obtained within 45 days prior to study entry (This criterion was removed in Version 2.0 of the protocol.)

You may not qualify if…

• 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 had received standard of care (e.g., hepatitis B, influenza, and tetanus) vaccines were 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 had undergone partial hysterectomy and had a cervix were not excluded.
• Hemophilia
• Currently on anticoagulation therapy other than acetylsalicylic acid
• Prior vaccination with an HPV vaccine
• Pregnant or breastfeeding

Where it is running

• Usc La Nichd Crs — Alhambra, California, United States
• University of California, UC San Diego CRS — La Jolla, California, United States
• Miller Children's Hosp. Long Beach CA NICHD CRS — Long Beach, California, United States
• University of Southern California CRS — Los Angeles, California, United States
• UCLA CARE Center CRS — Los Angeles, California, United States
• Stanford AIDS Clinical Trials Unit CRS — Palo Alto, California, United States
• UCSD Antiviral Research Center CRS — San Diego, California, United States
• Ucsf Hiv/Aids Crs — San Francisco, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Denver Public Health CRS — Denver, Colorado, United States
• Georgetown University CRS (GU CRS) — Washington D.C., District of Columbia, United States
• Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• South Florida CDTC Ft Lauderdale NICHD CRS — Fort Lauderdale, Florida, United States
• Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
• Pediatric Perinatal HIV Clinical Trials Unit CRS — Miami, Florida, United States
• The University of Miami AIDS Clinical Research Unit (ACRU) CRS — Miami, Florida, United States
• The Ponce de Leon Center CRS — Atlanta, Georgia, United States
• Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program — Chicago, Illinois, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Rush University CRS — Chicago, Illinois, United States
• Tulane Univ. New Orleans NICHD CRS — New Orleans, Louisiana, United States
• IHV Baltimore Treatment CRS — Baltimore, Maryland, United States
• Johns Hopkins University CRS — Baltimore, Maryland, United States
• Alabama Therapeutics CRS — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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