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A Single-Arm, Open-Label Pilot Trial of the Safety and Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Men


Phase 2
18 Years
N/A
Not Enrolling
Male
Infection, Precancerous Condition

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Trial Information

A Single-Arm, Open-Label Pilot Trial of the Safety and Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Men


OBJECTIVES:

Primary

- To assess the safety and tolerability of quadrivalent human papillomavirus (HPV) (types
6, 11, 16, 18) recombinant vaccine in HIV-infected men.

- To assess the immunogenicity of the quadrivalent HPV vaccine for types 6, 11, 16 and 18
in subjects who are antibody-negative at baseline.

Secondary

- To evaluate the changes in plasma HIV-1 RNA and CD4+ count after the vaccination
series.

- To describe the associations of CD4+ count, nadir CD4+ count, and age on antibody
response.

- To evaluate the levels and persistence of HPV 6, 11, 16, and 18 antibody titers after
the vaccination series among subjects according to serostatus at baseline.

- To evaluate the oral levels of serum IgA before and after the vaccination series.

Tertiary

- To evaluate prevalent and incident HPV infections in the anal canal.

- To evaluate cytological and histological abnormalities in the anal canal.

- To evaluate prevalent and incident HPV infections in the oral cavity.

- To compare oral and anal compartmental shedding of HPV before and after vaccination.

OUTLINE: This is a multicenter study.

Patients receive quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
intramuscularly on day 0 and weeks 8 and 24.

After completion of protocol therapy, patients are followed at 7, 12, and 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

Inclusion criteria:

- HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by
western blot prior to study entry

- HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a
method other than ELISA is acceptable as an alternative confirmatory test

- Anal human papilloma virus DNA PCR-negative for either type 16 and/or type 18 within
90 days prior to entry

- If receiving antiretroviral therapy:

- Receipt of antiretroviral therapy for at least 6 months prior to entry

- No change in antiretroviral therapy within 30 days prior to entry

- CD4 cell count > 200 cells/mm³ within 90 days prior to study entry

- HIV-1 RNA < 200 copies/mL within 90 days prior to entry

- If not receiving antiretroviral therapy:

- CD4 cell count ≥ 350 cells/mm³ within 90 days prior to study entry

- No plans to start antiretroviral therapy prior to week 28

- Normal anal cytological result, or atypical squamous cell of undetermined
significance or low-grade squamous intraepithelial lesions (SIL) result within 90
days prior to entry

Exclusion criteria:

- Current or history of anal or perianal carcinoma

- Anal cytological result of high-grade SIL (HSIL), atypical squamous cells suggestive
of HSIL, or suggestive of invasive carcinoma at screening or a history of these
results

- Presence of high-grade anal intraepithelial neoplasm (HGAIN) (e.g., AIN 2 or 3, or
perianal intraepithelial neoplasia grade 2 or 3), or invasive carcinoma at pre-entry,
or history of HGAIN

- Current or history of anal or peri-anal condyloma is allowed

PATIENT CHARACTERISTICS:

Inclusion criteria:

- Karnofsky performance status 70-100%

- Absolute neutrophil count > 750 cells/mm³

- Hemoglobin ≥ 9.0 g/dL

- Platelet count ≥ 100,000/mm³

- Creatinine clearance ≥ 60 mL/min

- AST and ALT ≤ 3 times ULN

- Total or conjugated (direct) bilirubin ≤ 2.5 times ULN

Exclusion criteria:

- Serious medical or psychiatric illness, active drug or alcohol use, or dependence
that, in the opinion of the site Investigator, would interfere with adherence to
study requirements

- Serious illness requiring systemic treatment and/or hospitalization within the past
45 days

- Allergy to yeast or any of the components of quadrivalent human papillomavirus (types
6, 11, 16, 18) recombinant vaccine

- Hemophilia

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

- See Disease Characteristics

Exclusion criteria:

- Prior splenectomy

- Currently receiving anticoagulation therapy other than acetylsalicylic acid

- Use of any systemic antineoplastic or immunomodulatory treatment, systemic
corticosteroids, investigational vaccines, interleukins, interferons, growth factors,
or IVIG within 45 days prior to study entry

- Routine standard of care, including hepatitis A or B, influenza, or pneumococcal
and tetanus vaccines are not excluded

- Hepatitis C co-infected patients are eligible provided no concurrent initiation
of treatment for hepatitis C

- Prior receipt of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine or other
HPV vaccine

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine

Outcome Time Frame:

All study visits

Safety Issue:

Yes

Principal Investigator

Timothy J. Wilkin, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Federal Government

Study ID:

CDR0000559149

NCT ID:

NCT00513526

Start Date:

November 2007

Completion Date:

October 2011

Related Keywords:

  • Infection
  • Precancerous Condition
  • infection
  • low-grade squamous intraepithelial lesion
  • atypical squamous cells of undetermined significance
  • Precancerous Conditions

Name

Location

Montefiore Medical CenterBronx, New York  10467-2490
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Denver Health Medical CenterDenver, Colorado  80204-4507
UCLA Clinical AIDS Research and Education (CARE) CenterLos Angeles, California  90024
Boston University Cancer Research CenterBoston, Massachusetts  02118
Benaroya Research Institute at Virginia Mason Medical CenterSeattle, Washington  98101
Laser Surgery CareNew York, New York  10011