Evaluation of the Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine 580299 (Cervarix TM) in Adult Human Immunodeficiency Virus (HIV) Infected Female Subjects
- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol
- A female between, and including, 18 and 25 years of age at the time of the first
- Written, signed or thumb-printed informed consent obtained from the subject prior to
- Subjects willing to undergo HIV Voluntary Counseling and Testing (VCT) and willing
to be informed of their HIV status.
- Subjects willing to provide place of residence and be visited at home.
- HIV seropositive subjects:
1. Subjects must be HIV seropositive according to WHO case definition
2. Subjects with WHO Clinical Stage 1 HIV-associated disease
3. Subjects currently on antiretroviral therapy (ART) must be compliant to ART and
have undetectable viral load
- HIV seronegative subjects: Subjects confirmed as HIV seronegative at the screening
visit are eligible to participate in the HIV-/HPV group of the study.
- Non-virgin subjects must have a normal colposcopy at the screening visit.
- Non-virgin subjects must have a normal cervical cytology (Pap smear) or no greater
than atypical squamous cells of undetermined significance (ASC-US) at the screening
- All subjects must have a negative urine pregnancy test at the screening visit and at
visit 1 (Day 0).
- Subjects must be of non-childbearing potential or, if of childbearing potential, 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 must have had no more than 6 life-time sexual partners prior to enrolment.
- Subjects must have one single intact cervix
- Active tuberculosis (TB)
- Current TB prophylaxis or therapy.
- Anemia at the screening visit.
- increased creatinine at the screening visit.
- Increased hepatic enzym (ALT) at the screening visit
- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine within 30 days preceding the first dose of study vaccine/control, or
planned use during the entire study period (up to Month 12).
- Chronic administration of immunosuppressants or other immune-modifying drugs within 6
months prior to the first vaccine dose.
- Administration of a vaccine not foreseen by the study protocol within 30 days before
the first dose of study vaccine/control. Enrolment will be postponed until the
subject is outside the specified window.
- Planned administration of a vaccine not foreseen by the study protocol within 30 days
before or 30 days after (i.e., Days 0-29) any dose of study vaccine.
- Previous vaccination against HPV, or planned administration of any HPV vaccine other
than that foreseen by the study protocol during the study period (Month 0 to Month
- previous administration of components of the investigational vaccine
- Cancer or autoimmune disease under treatment.
- Hypersensitivity to latex.
- History of allergic disease or reactions likely to be exacerbated by any component of
- Acute disease at the time of enrolment.
- 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.
- History of any neurological disorders or seizures.
- Pregnant or breastfeeding female.
- A subject planning to become pregnant, likely to become pregnant (as determined by
the investigator) or planning to discontinue contraceptive precautions during the
study period, up to two months after the last vaccine dose.
- Concurrently participating in another clinical study, at any time during the study
period (up to Month 12), in which the subject has been or will be exposed to an
investigational or a non-investigational product (pharmaceutical product or device).
- Any medically diagnosed or suspected immunodeficient condition (other than HIV for
HIV seropositive subjects), based on medical history, physical examination and/or
laboratory tests results.
- Administration of immunoglobulins and/or any blood products within the three months
preceding the first dose of study vaccine/control or planned administration during
the study period. Enrolment will be postponed until the subject is outside the
- Administration of trimethoprim/sulphamethoxazole within 7 days before the first dose
of study vaccine/control, or planned administration of trimethoprim/sulphamethoxazole
within 7 days after the first dose of study vaccine/control.
- Current drugs or alcohol abuse.