Human papillomavirus (HPV) Infections and Infestations Viral agents as the cause of diseases classified to other chapters
Conditions
Interventions
The intervention is GSK Biologicals' candidate HPV vaccine containing HPV-16/18 L1 proteins and AS04 adjuvant administered intramuscularly using a three-dose schedule (0, 1, 6 months).
The placebo co
Sponsors
London School of Hygiene & Tropical Medicine (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female subjects aged 10-25 years 2. Subjects who the investigator believes that they and/or their parents/legally acceptable representative can and will comply with the requirements of the protocol should be enrolled in the study 3. A female between, and including, 10 and 25 years of age at the time of the first vaccination 4. Written or oral, signed or thumb printed or witnessed informed consent obtained from the subject prior to enrolment for both the main GSK vaccine trial and for the epidemiological studies on HPV. For subjects below legal age of consent, written or oral, signed or thumb printed or witnessed informed consent obtained from the subject's parent or legally acceptable representative. 5. Free of obvious health problems as established by medical history, clinical examination and laboratory testing before entering into the study. 6. Subjects must have a negative urine pregnancy test at the screening visit and at Visit 1 (Day 0) 7. Subjects must be seronegative for human immunodeficiency virus (HIV) at the screening visit 8. Subjects must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions. 9. Subjects must have had no more than 6 sexual partners prior to enrolment 10. Subjects must be willing to undergo HIV voluntary counselling and testing and must be willing to be informed of their HIV status. Subjects below legal age of consent must also be willing to have their parent or legally acceptable representative informed of their HIV status.
Exclusion criteria
Exclusion criteria: 1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12) 2. Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned administration during the study period 3. Administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine. Enrolment will be deferred until the subject is outside of specified window. 4. Planned administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after any dose of study vaccine 5. Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period 6. Previous administration of components of the investigational vaccine 7. Cancer or autoimmune disease under treatment 8. Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection based on laboratory testing performed during the screening visit 9. Hypersensitivity to latex 10. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine/control 11. Acute disease at the time of enrolment 12. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory testing performed at the screening visit 13. History of any neurologic disorders or seizures 14. Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period 15. Pregnant or breastfeeding female 16. A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose 17. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Prevalence at enrolment and incidence of genital HPV infection at Month 12 2. Prevalence of cervical pathology at enrolment 3. Influence of presence and/or burden of parasitic infection on vaccine response at Month 7 4. Effect of prior HPV infection (in particular with types targeted by the vaccine) on the response to HPV vaccine at Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. HIV and STI prevalence and incidence 2. Risk factors for HIV and STI Assessment schedule: Screening (day -30): a. Sero-prevalence of HIV and risk factors for HIV b. Sero-prevalence of HPV and risk factors for HPV Enrolment (day 0): Prevalence of and risk factors for genital HPV infection and other reproductive tract infections Month 12: Incident HIV and incident genital HPV infection | — |
Countries
Tanzania
Outcome results
None listed