Contact information
Type
Scientific
Primary contact
Dr Deborah Watson-Jones
ORCID ID
Contact details
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7927 2116
deborah.watson-jones@lshtm.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
These epidemiological studies are nested within a Phase IIIB trial examining the immunogenicity and safety of GSK's bivalent vaccine in Mwanza, Tanzania (ClinicalTrials.gov identifier NCT00481767). The objectives of the studies are to:
1. Measure the prevalence and incidence of genital human papillomavirus (HPV) infection and the prevalence of cervical pathology in the HPV vaccine cohort and risk factors for HPV infection
2. Measure HIV prevalence (at screening) and incidence (at 12 months) and risk factors for infection in cohort at screening
3. Measure prevalence of sexually transmitted infections (STIs) and risk factors for infection
4. Determine whether the presence and/or burden of parasitic infections influence the vaccine response
5. Determine whether prior HPV infection (in particular with types targeted by the vaccine) modifies the response to vaccination
Ethics approval
1. Ethics Committee of the London School of Hygiene & Tropical Medicine (LSHTM) (UK), approved on 05/06/2008 (ref: 5305)
2. Medical Research Coordinating Committee of the National Institute for Medical Research (Tanzania), approved on 20/05/2008
Study design
Supplementary epidemiological studies nested within a double-blind randomised placebo-controlled phase IIIB trial
Primary study design
Observational
Secondary study design
Other
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Human papillomavirus (HPV)
Intervention
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 control injection, given using the same dose schedule, contains 500 µg of aluminium as Al(OH)3.
Intervention type
Drug
Phase
Phase III
Drug names
Human papillomavirus (HPV) vaccine (GSK serial number: 580299)
Primary outcome measures
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 outcome measures
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
Overall trial start date
20/10/2008
Overall trial end date
30/05/2010
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Other
Gender
Female
Target number of participants
330
Participant 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)
Recruitment start date
20/10/2008
Recruitment end date
30/05/2010
Locations
Countries of recruitment
Tanzania
Trial participating centre
London School of Hygiene & Tropical Medicine
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
London School of Hygiene & Tropical Medicine (UK)
Sponsor details
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7827 2678
Penny.Ireland@lshtm.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
GSK Biologicals (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary