Vaccine Therapy in Preventing Human Papillomavirus Infection in Young Participants Who Are Either HIV-Positive or HIV-Negative - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00798265

Purpose

RATIONALE: Vaccine therapy may be effective in preventing human papillomavirus infection in young participants.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy in preventing human papillomavirus infection in young participants who are either HIV-positive or HIV-negative.

Condition	Intervention	Phase
Anal Cancer Cervical Cancer Penile Cancer Precancerous/Nonmalignant Condition Vulvar Cancer	Drug: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine Procedure: DNA analysis Procedure: RNA analysis Procedure: immunologic technique Procedure: laboratory biomarker analysis Procedure: protein analysis Procedure: survey administration	Phase I

MedlinePlus related topics: AIDS Anal Cancer Cancer Vulvar Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized
Official Title:	A Phase I Study of Quadrivalent Human Papilloma Virus (HPV) (Types 6,11, 16, 18) Recombinant Vaccine in HIV-Infected and HIV-Negative Pre-Adolescents, Adolescents and Young Adults

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Vaccine-induced antibody titer difference between the 3 cohorts at baseline and months 7, 12, 24, and 48 [ Designated as safety issue: No ]
Vaccine-induced HIV-1 RNA levels between cohorts 1 and 2 at baseline, days 3 and 7, and months 1, 3, 7, and 12 [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlation of increase in HPV titer with baseline CD4 count and viral load [ Designated as safety issue: No ]

Estimated Enrollment:	105
Study Start Date:	October 2008
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To assess the immunogenicity and safety of the quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (HPV vaccine) in HIV-infected pre-adolescents, adolescents, and young adults.

Secondary

To determine whether there are differences in HPV vaccine immunogenicity between HIV-infected and HIV-uninfected age-matched controls.
To determine whether there are differences in HPV vaccine immunogenicity between HIV-infected patients receiving highly active antiretroviral therapy (HAART) and those not receiving HAART with similar CD4 and viral-load parameters at entry.
To determine whether HPV vaccination alters HIV-1 RNA levels.
To investigate the impact of CD4 count and HIV-1 RNA levels on immunogenicity.
To characterize human papillomavirus (HPV) DNA positivity by oral/buccal and anogenital swabs at baseline.
To characterize HPV and HIV knowledge and risk and sexual behaviors.

OUTLINE: Participants receive intramuscular quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine at 0, 2, and 6 months.

All participants complete human papillomavirus (HPV)/HIV knowledge and risk and sexual behavior surveys and undergo oral rinse/buccal swab and external anogenital sampling for HPV DNA testing at baseline. Blood samples are collected periodically for CD4 cell count, functional HPV antibody assay, HPV-specific lymphocyte proliferation assays (LPA), and cytokine profiling. HIV-positive patients (cohorts 1 and 2) also have blood samples collected for analysis of immunologic responses, HIV-1 RNA levels, and HIV-specific LPA.

After completion of study therapy, patients are followed periodically for 1 year and then every 6 months for 3 years.

NOTE: Preventing human papillomavirus (HPV) infection may prevent some HPV-associated cancers, such as cervical cancer and anogenital (vulvar, vagina, penis and anus) cancer.

Eligibility

Ages Eligible for Study:	12 Years to 26 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Participants meeting one of the following criteria:
- HIV-positive (cohorts 1 and 2)
  - CD4 cell count ≥ 350/mm^3
  - HIV-1 RNA level by real time PCR ≤ 20,000 copies/mL
  - Patients on stable highly active antiretroviral therapy for ≥ 6 months (cohort 1 only)
    - No history of non-adherence to therapy within the past 12 months
- Healthy, HIV-negative controls (cohort 3)

PATIENT CHARACTERISTICS:

Neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 75,000/mm^3
Hemoglobin ≥ 10.0 g/dL
PT or PTT < 1.5 times upper limit of normal (ULN) (except for patients with known clotting disorders or known lupus anticoagulant)
ALT and/or AST ≤ 2.5 times ULN
Total bilirubin ≤ 1.5 times ULN (unless attributable to protease-inhibitor therapy)
Negative pregnancy test
Not pregnant or nursing
Fertile patients must use effective contraception
No positive tests for hepatitis B or C antibodies and/or antigens (unless the result is consistent with prior vaccination or prior infection with full recovery)
No concurrent acute infection requiring therapy unless on stable and appropriate antiinfective therapy
No known immediate hypersensitivity to yeast or any of the vaccine components
No clinically significant disease (other than HIV infection for Cohorts 1 and 2) or findings during study screening that, in the opinion of the principal investigator or lead associate investigator, may interfere with the study

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
At least 8 weeks since prior immunosuppressors or immunomodulators
- Topical and inhaled steroids allowed
- Oral corticosteroids for management of asthma or contact hypersensitivity for ≤ 14 days duration permitted provided it has been ≥ 30 days since oral corticosteroid administration
- No pharmacologic doses of immune-modulating agents including intravenous immunoglobulin (IVIG)
At least 4 weeks since prior investigational agents
No concurrent recombinant cytokines or growth factors
No concurrent cyclophosphamide, hydroxyurea, methotrexate, or other immunosuppressive drugs
No concurrent chemotherapy for active cancer
No initiation of antiretroviral therapy prior to month 7 of study therapy (cohort 2)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798265

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Lauren V. Wood, MD

NCI - Vaccine Branch

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000625982, NCI-09-C-0024, NCI-P07277
Study First Received:	November 25, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00798265
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

human papilloma virus infection
cervical cancer
vulvar cancer

anal cancer
penile cancer
HIV infection

Study placed in the following topic categories:

Precancerous Conditions
Genital Neoplasms, Male
Rectal Neoplasms
Gastrointestinal Diseases
Urogenital Neoplasms
Rectal Diseases
Genital Diseases, Female
Vulvar Neoplasms
Penile Neoplasms
Papilloma
Rectal cancer
Digestive System Neoplasms
Skin Diseases
Acquired Immunodeficiency Syndrome
Genital Neoplasms, Female

Genital Diseases, Male
Intestinal Diseases
Intestinal Neoplasms
Rectal neoplasm
Virus Diseases
Skin Diseases, Infectious
Warts
Digestive System Diseases
HIV Seropositivity
HIV Infections
Gastrointestinal Neoplasms
DNA Virus Infections
Papillomavirus Infections
Anal cancer
Anus Neoplasms

Additional relevant MeSH terms:

Skin Diseases, Viral
Neoplasms
Neoplasms by Site

Tumor Virus Infections
Penile Diseases
Anus Diseases

ClinicalTrials.gov processed this record on January 16, 2009