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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 CRS Birmingham, Alabama  35294
UCLA CARE Center CRS Los Angeles, California  90095
USC CRS Los Angeles, California  90033
Stanford CRS Palo Alto, California  94305
Ucsd, Avrc Crs San Diego, California  
Ucsf Aids Crs San Francisco, California  
University of Colorado Hospital CRS Aurora, Colorado  80262
Univ. of Miami AIDS CRS Miami, Florida  33136
Northwestern University CRS Chicago, Illinois  60611
Rush Univ. Med. Ctr. ACTG CRS Chicago, Illinois  60612
Johns Hopkins Adult AIDS CRS Baltimore, Maryland  21287
Massachusetts General Hospital ACTG CRS Boston, Massachusetts  02114
Beth Israel Deaconess Med. Ctr., ACTG CRS Boston, Massachusetts  02215
Bmc Actg Crs Boston, Massachusetts  02118
Washington U CRS St. Louis, Missouri  
NY Univ. HIV/AIDS CRS New York, New York  10016
Univ. of Rochester ACTG CRS Rochester, New York  14642
Unc Aids Crs Chapel Hill, North Carolina  27599
Duke Univ. Med. Ctr. Adult CRS Durham, North Carolina  27710
Regional Center for Infectious Disease, Wendover Medical Center CRS Greensboro, North Carolina  27401
Univ. of Cincinnati CRS Cincinnati, Ohio  45267
Case CRS Cleveland, Ohio  44106
MetroHealth CRS Cleveland, Ohio  
Hosp. of the Univ. of Pennsylvania CRS Philadelphia, Pennsylvania  19104
University of Washington AIDS CRS Seattle, Washington  98122
Pitt CRS Pittsburgh, Pennsylvania  15213
Usc La Nichd Crs Los Angeles, California  90033
Univ. of Florida Jacksonville NICHD CRS Jacksonville, Florida  
HIV Prevention & Treatment CRS New York, New York  10032
The Ohio State University Medical Center Columbus, Ohio  43210
The Ponce de Leon Ctr. CRS Atlanta, Georgia  30308
IHV Baltimore Treatment CRS Baltimore, Maryland  21201
AIDS Care CRS Rochester, New York  14607
Vanderbilt Therapeutics CRS Nashville, Tennessee  37204
Miller Children's Hosp. Long Beach CA NICHD CRS Long Beach, California  90806
Denver Public Health CRS Denver, Colorado  80204
Georgetown University CRS (GU CRS) Washington, District of Columbia  20007
Howard Univ. Washington DC NICHD CRS Washington, District of Columbia  20060
Univ. of Miami Ped. Perinatal HIV/AIDS CRS Miami, Florida  33136
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program Chicago, Illinois  60608
Rush Univ. Cook County Hosp. Chicago NICHD CRS Chicago, Illinois  60612
Tulane Univ. New Orleans NICHD CRS New Orleans, Louisiana  70112
Henry Ford Hosp. CRS Detroit, Michigan  48202
Cooper Univ. Hosp. CRS Camden, New Jersey  08103
Columbia IMPAACT CRS New York, New York  10032
Cornell CRS New York, New York  10011
The Research & Education Group-Portland CRS Portland, Oregon  97210
Thomas Jefferson Univ. Med. Ctr. CRS Philadelphia, Pennsylvania  19107
The Miriam Hosp. ACTG CRS Providence, Rhode Island  02906
Trinity Health and Wellness Center CRS Dallas, Texas  75208
Houston AIDS Research Team CRS Houston, Texas  77030
Virginia Commonwealth Univ. Medical Ctr. CRS Richmond, Virginia  23298
New Jersey Medical School- Adult Clinical Research Ctr. CRS Newark, New Jersey  07103
UCSD Mother-Child-Adolescent Program CRS San Diego, California  92103
South Florida CDTC Ft Lauderdale NICHD CRS Fort Lauderdale, Florida  33316
Texas Children's Hosp. CRS Houston, Texas  77030