the HANDS HPV Vaccine Trial
- Conditions
- CancerHPV infection
- Registration Number
- PACTR202101499206800
- Lead Sponsor
- Medical Research Council Unit The Gambia at LSHTM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 1720
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
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 participant20. 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 [167-171].
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Competitive Luminex immunoassay (cLIA) will be used to assess the primary objectives. The Geometric mean titer (GMT) responses to the nine HPV types included in Gardasil-9 will be assessed and compared for non-inferiority for the 4 to 8 year olds who received 2 doses and 9 to14 year olds who received 2 doses against the 15 to 26 year olds who receive 3 doses of the vaccine
- Secondary Outcome Measures
Name Time Method Competitive Luminex immunoassay (cLIA) will be used to assess the secondary objectives. Comparing for non-inferiority in the seroconversion of all nine HPV types included in Gardasil-9 in the 4 to 8 year old 1 and 2 doses groups, the 9 to 14 year old 1 and 2 doses group against the 15 to 26 year old 3 dose groups.