Status:
COMPLETED
Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Sexually Transmitted Diseases
Eligibility:
All Genders
7-12 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety of and immune response to a new human papillomavirus (HPV) vaccine in HIV (Human immunodeficiency virus) infected children between the ages of 7 an...
Detailed Description
Genital HPV infection is the most common sexually transmitted infection in the world and may lead to genital warts, anogenital dysplasias, and invasive cancers. HIV infected people and others with com...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Children ages ≥ 7 to \< 12 years of age.
- A confirmed diagnosis of HIV infection, defined as two positive assays from two different samples. The two results may be in any combination of the following:
- at any age: Deoxyribonucleic acid (DNA) polymerase chain reaction (PCR), Ribonucleic acid (RNA) PCR
- age \> 4 weeks: p24 antigen detection
- age \>18 months: licensed ELISA (Enzyme-linked immunosorbent assay) with confirmatory Western Blot
- CD4% ≥ 15 at the time of screening is required (Note that this is a minimum requirement, and that for Stratum C the CD4% needs to be ≥ 25).
- For Strata A and B: Currently stable (≥ 3 months) on highly active antiretroviral therapy (HAART) regimen, defined as three or more antiretrovirals from at least two different therapeutic classes, or therapy with the combination of azidothymidine, lamivudine, and abacavir.
- For stratum C no antiretroviral therapy is required.
- Parent or legal guardian able and willing to provide signed informed consent.
- Negative urine pregnancy test sensitive to 25 International Unit (IU) beta-human chorionic gonadotropin (HCG) for girls who are menstruating (child bearing potential).
- Female study volunteers who are participating in sexual activity that could lead to pregnancy must agree to use two reliable methods of contraception, one of which must be a barrier method. A barrier method of contraception (condoms or cervical cap) together with another reliable form of contraception (condoms a , with a spermicidal agent; a diaphragm or cervical cap with spermicide; an intrauterine device \[IUD\]; or hormonal-based contraception) must be used while on this study. Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV-1 transmission
- Males participating in the study must not attempt to impregnate a woman, or participate in sperm donation programs. Males engaging in sexual activity that could lead to pregnancy must use a condom.
- Exclusion Criteria
- Body temperature ≥ 101 F or ≥ 38.3 C, orally determined, within 72 hours prior to the first and each subsequent injection. Subjects may be vaccinated any time in the next seven days thereafter, provided that the site investigator is satisfied that the febrile illness has ended.
- Total bilirubin ≥ 5 x Upper Limit of Normal (ULN) at screening.
- Alanine transaminase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 5 x ULN at screening in the absence of other explained causes (as determined by the site investigator) at screening.
- Serum creatinine ≥ 1.5 mg/dL at screening.
- Absolute neutrophil count ≤ 750 cells/mm3 at screening.
- Hemoglobin ≤ 9.9 g/dL at screening.
- Platelet count ≤ 75,000 cells/mm³ at screening.
- Presence of an acute opportunistic non-bacterial or bacterial infection requiring therapy at the time of enrollment; the subject may be entered once he/she is stable on appropriate anti-infective therapy.
- Chemotherapy for active malignancy.
- Other known or suspected disease of the immune system, or immunosuppressive therapy.
- Prior treatment with immunosuppressive or immunomodulation therapy within 60 days of screening.
- Prior treatment with three or more week-long courses of corticosteroids (≥ 2.0 mg/kg or ≥ 20 mg total of prednisone-equivalent) within one year of screening; or any systemic (oral or parenteral) steroids (≥ 2.0 mg/kg or ≥ 20 mg total of prednisone-equivalent for ≥ 3 days) within 30 days of study entry.
- Prior vaccinations with inactivated vaccines received within two weeks of any dose of study vaccine, and no other vaccinations may be planned for two weeks after each dose of study vaccine.
- Prior vaccinations with live vaccines received within three weeks before any dose of study vaccine, and no other vaccinations may be planned for two weeks after each dose of study vaccine.
- Prior diagnosis of sexually transmitted infections (STIs), genital warts, or juvenile recurrent papillomatosis.
- History of any severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention.
- Known allergies to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed \[used to remove residual nucleic acids from this and other vaccines\]).
- Previous treatment with any immune globulin preparation or blood-derived products within the six months prior to the first injection and none may be planned during the study.
- Known coagulation disorder that would contraindicate Intramuscular (IM) injections.
- Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise the outcome of this study.
- Breastfeeding.
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00339040
Start Date
October 1 2006
End Date
August 1 2009
Last Update
November 5 2021
Active Locations (34)
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1
Usc La Nichd Crs
Alhambra, California, United States, 91803
2
Miller Children's Hosp. Long Beach CA NICHD CRS
Long Beach, California, United States, 90806
3
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States, 90095-1752
4
Children's Hosp. of Orange County
Orange, California, United States, 92868-3874