Status:
UNKNOWN
HPV Vaccination in Africa- New Delivery Schedules Alias The HANDS HPV Vaccine Trial
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Public Health England
University of Cambridge
Conditions:
Human Papillomavirus Vaccine
Eligibility:
FEMALE
4-26 years
Phase:
PHASE3
Brief Summary
A randomized, observer-blind non-inferiority trial to evaluate alternative human papillomavirus (HPV) vaccination schedules in young females in West Africa.
Detailed Description
This study is a randomized, open-label, single-centre, phase 3 non-inferiority clinical trial of the Gardasil 9 vaccine. It will be undertaken in three female cohorts (15 to 26 years old; 9 to 14 year...
Eligibility Criteria
Inclusion
- Signed/thumb-printed informed consent obtained from the participant's parent (4 to 17 year-olds) or signed/thumb-printed informed consent obtained from the participant (18 years and above)
- Signed/thumb-printed assent obtained from the participant (12 to 17 year-olds only).
- Documented verbal assent obtained from the participant (6 to 11 year-olds only)
- Participant is of female sex (based on participant/parent self-report)
- Participant is between 4 and 26 years of age inclusive
- Parent/participant is willing and judged able to comply with the necessary study procedures
- Parent/participant does not have established plans to leave the study area for a prolonged period/indefinitely during the 3 year follow-up period
- Participant is resident within the study area (no fixed boundaries will be set and decisions will be made on a case-by-case basis by the study team taking into account not only distance but also transport links, accessibility for the purposes of safety data collection, willingness of the parent/participant to travel)
- Place of residence of the participant must be readily identifiable
Exclusion
- Receipt of other investigational medicinal products (IMP) in a period of 12 months prior to the day of randomization and vaccination or plans to receive IMP during the trial.
- Presence of significant chronic health problems requiring long-term medication or medical follow-up including respiratory, cardiac, gastrointestinal, hepatic, renal, neurological, musculoskeletal, haematological or other conditions based on parental history and physical examination of the participant. Participants with known sickle cell disease (but not sickle cell trait) will be excluded.
- History of severe allergic reactions to any prior vaccine or to any component of the study vaccine (including alum (amorphous aluminum hydroxyphosphate sulphate), yeast or Benzonase). Severe allergic reactions are defined as reactions requiring urgent medical intervention including reactions with any degree of cardiorespiratory compromise. The occurrence of a mild rash without other associated symptoms or signs does not generally represent an exclusion. Allergic reactions should be distinguished from the local and systemic reactogenicity expected in the first few days following vaccination which is not an exclusion to vaccination
- Prior receipt of an HPV vaccine
- Receipt of any vaccine in the 28 days prior to randomization and vaccination‡
- History of thrombocytopenia or coagulation disorders which represent contraindications in intramuscular (IM) vaccination
- Known congenital or acquired immune deficiency or history strongly indicative of abnormal immune function. HIV testing will not be undertaken as part of the routine screening procedures due to the relatively low prevalence of HIV expected in the population (\~1-3%) and the established safety and immunogenicity profile of Gardasil in HIV positive individuals.
- Receipt of medications or other treatments known to suppress the immune system in a period of 12 months prior to the day of randomization or plans to receive such medications and treatments during the course of the trial. Such medications and treatments include but not limited to high dose non-replacement) oral or parenteral steroids for more than 14 days, chemotherapeutic agents, methotrexate, cyclophosphamide, cyclosporin, Tacrolimus, any monoclonal antibody therapy and radiotherapy. The use of topical and inhaled steroids are not exclusion criteria.
- Receipt of intravenous immunoglobulins or blood products within a period of 12 months prior to the day of randomization and vaccination or plans to receive such products during the course of the trial.
- Pregnancy (females in the 15 to 26 years old cohort will require a urine pregnancy test as part of the screening procedures and will also have a urine pregnancy test undertaken prior to the second and third vaccination and vaccination delayed if pregnancy is confirmed. A minimum of 42 days from the end of pregnancy (irrespective of outcome) will be left before the delayed vaccination is administered. Participants who are pregnant at initial screening will not be re-screened but will be defined as screen failures. Breast feeding is not an exclusion criterion
- Intention to become pregnant within six months of enrollment in the trial. Confirmation regarding the use of a reliable method of contraception is not required but females who are actively seeking to become pregnant within six months of enrollment will be excluded.
- Fever (\>38.0°C) on the day of vaccination or documented fever (\>38.0°C) within the 24 hours preceding vaccination
- Abnormal (Grade \> 1) vital signs (heart rate, respiratory rate, blood pressure) on the day of vaccination
- Positive rapid diagnostic test (RDT) or blood film for malaria on the day of vaccination
- Clinically-significant (Grade \> 2) acute illness present on the day of vaccination (minor illnesses including upper respiratory tract infections, diarrhoeal illness and skin complaints not associated with fever or significant systemic upset are not in themselves reasons for exclusion)
Key Trial Info
Start Date :
September 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
1720 Patients enrolled
Trial Details
Trial ID
NCT03832049
Start Date
September 14 2019
End Date
June 1 2024
Last Update
March 31 2022
Active Locations (1)
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1
Ed Clarke
Banjul, Outside U.S. and Canada, The Gambia, PO Box 273