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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
Female
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
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

Type of Study:

Interventional

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:

No

Principal Investigator

Erna Milunka Kojic, MD

Investigator Role:

Study Chair

Investigator Affiliation:

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

Authority:

United States: Food and Drug Administration

Study ID:

A5240

NCT ID:

NCT00604175

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

Name

Location

Alabama Therapeutics CRSBirmingham, Alabama  35294
UCLA CARE Center CRSLos Angeles, California  90095
USC CRSLos Angeles, California  90033
Stanford CRSPalo Alto, California  94305
Ucsd, Avrc CrsSan Diego, California  
Ucsf Aids CrsSan Francisco, California  
University of Colorado Hospital CRSAurora, Colorado  80262
Univ. of Miami AIDS CRSMiami, Florida  33136
Northwestern University CRSChicago, Illinois  60611
Rush Univ. Med. Ctr. ACTG CRSChicago, Illinois  60612
Johns Hopkins Adult AIDS CRSBaltimore, Maryland  21287
Massachusetts General Hospital ACTG CRSBoston, Massachusetts  02114
Beth Israel Deaconess Med. Ctr., ACTG CRSBoston, Massachusetts  02215
Bmc Actg CrsBoston, Massachusetts  02118
Washington U CRSSt. Louis, Missouri  
NY Univ. HIV/AIDS CRSNew York, New York  10016
Univ. of Rochester ACTG CRSRochester, New York  14642
Unc Aids CrsChapel Hill, North Carolina  27599
Duke Univ. Med. Ctr. Adult CRSDurham, North Carolina  27710
Regional Center for Infectious Disease, Wendover Medical Center CRSGreensboro, North Carolina  27401
Univ. of Cincinnati CRSCincinnati, Ohio  45267
Case CRSCleveland, Ohio  44106
MetroHealth CRSCleveland, Ohio  
Hosp. of the Univ. of Pennsylvania CRSPhiladelphia, Pennsylvania  19104
University of Washington AIDS CRSSeattle, Washington  98122
Pitt CRSPittsburgh, Pennsylvania  15213
Usc La Nichd CrsLos Angeles, California  90033
Univ. of Florida Jacksonville NICHD CRSJacksonville, Florida  
HIV Prevention & Treatment CRSNew York, New York  10032
The Ohio State University Medical CenterColumbus, Ohio  43210
The Ponce de Leon Ctr. CRSAtlanta, Georgia  30308
IHV Baltimore Treatment CRSBaltimore, Maryland  21201
AIDS Care CRSRochester, New York  14607
Vanderbilt Therapeutics CRSNashville, Tennessee  37204
Miller Children's Hosp. Long Beach CA NICHD CRSLong Beach, California  90806
Denver Public Health CRSDenver, Colorado  80204
Georgetown University CRS (GU CRS)Washington, District of Columbia  20007
Howard Univ. Washington DC NICHD CRSWashington, District of Columbia  20060
Univ. of Miami Ped. Perinatal HIV/AIDS CRSMiami, Florida  33136
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV ProgramChicago, Illinois  60608
Rush Univ. Cook County Hosp. Chicago NICHD CRSChicago, Illinois  60612
Tulane Univ. New Orleans NICHD CRSNew Orleans, Louisiana  70112
Henry Ford Hosp. CRSDetroit, Michigan  48202
Cooper Univ. Hosp. CRSCamden, New Jersey  08103
Columbia IMPAACT CRSNew York, New York  10032
Cornell CRSNew York, New York  10011
The Research & Education Group-Portland CRSPortland, Oregon  97210
Thomas Jefferson Univ. Med. Ctr. CRSPhiladelphia, Pennsylvania  19107
The Miriam Hosp. ACTG CRSProvidence, Rhode Island  02906
Trinity Health and Wellness Center CRSDallas, Texas  75208
Houston AIDS Research Team CRSHouston, Texas  77030
Virginia Commonwealth Univ. Medical Ctr. CRSRichmond, Virginia  23298
New Jersey Medical School- Adult Clinical Research Ctr. CRSNewark, New Jersey  07103
UCSD Mother-Child-Adolescent Program CRSSan Diego, California  92103
South Florida CDTC Ft Lauderdale NICHD CRSFort Lauderdale, Florida  33316
Texas Children's Hosp. CRSHouston, Texas  77030