Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202101499206800 Date of Approval: 30/01/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title the HANDS HPV Vaccine Trial
Official scientific title A randomized, observer-blind, non-inferiority trial to evaluate alternative human papillomavirus (HPV) vaccination schedules in females in West Africa
Brief summary describing the background and objectives of the trial A randomized, observer-blind non-inferiority trial to evaluate alternative human papillomavirus (HPV) vaccination schedules in young females in West Africa
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HANDS
Disease(s) or condition(s) being studied Cancer,Infections and Infestations
Sub-Disease(s) or condition(s) being studied HPV infection
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/07/2019
Actual trial start date 16/09/2019
Anticipated date of last follow up 31/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 1720
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NCT03832049 ClinicalTrials.gov register
SCC 1597 Medical Research Council The Gambia Scientific Coordinating Committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Gardasil 9 Females in the 9 to 14 year-old will be randomised to receive two doses of Gardasil 9 two doses will be administered at 0 and 6 months Females in the 9 to 14 year-old a cohorts will be randomized to receive two doses of Gardasil 9 to be administered at 0 and 6 months 344
Experimental Group Gardasil 9 Females in the 9 to 14 year-old will receive one dose of Gardasil 9 which will be administered at baseline at baseline Females in the 9 to 14 year-old cohort will be randomized to receive one dose of Gardasil 9 which will be administered at baseline 344
Experimental Group Gardasil 9 Females in 4 to 8 years old will be randomized to receive two doses of Gardasil 9 which will be administered at 0 and 6 months at 0 and 6 months Females in the 4 to 8 year-old cohorts will be randomized to receive two doses of Gardasil 9, the two doses will be administered at 0 and 6 months 344
Experimental Group Gardasil 9 Females in the 4 to 8 year-old cohort will be randomized to receive one dose of Gardasil 9 which will be administered at baseline at baseline Females in the 4 to 8 year-old cohort will be randomized to receive one dose of Gardasil 9, to be administered at baseline 344
Control Group Gardasil 9 Three doses of Gardasil 9 at 0, 2 and 6 months at 0, 2 and 6 months Females within the 15 to 26 year-old cohort will receive three doses of Gardasil 9 at 0, 2 and 6 months and represent the reference group 344 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 4 Year(s) 26 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/06/2018 The Gambia Government MRC Joint Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Atlantic Road Banjul 0000 Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 6 weeks after the last dose of the vaccine received according to group
Secondary Outcome 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. 6 weeks after the last dose of vaccine received according to the group
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MRC Unit The Gambia Atlantic road Banjul Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Joint Global Health Trials North Star Avenue Swindon United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Council Unit The Gambia at LSHTM Atlantic Road Banjul Gambia Research Institution
COLLABORATORS
Name Street address City Postal code Country
Margaret Stanley University of Cambridge Cambridge United Kingdom
Simon Beddows Public Health England London United Kingdom
Mark Jit London School of Hygiene and Tropical Medicine London United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ed Clarke eclarke@mrc.gm +2204495443 Atlantic Road
City Postal code Country Position/Affiliation
Banjul Gambia Principal Investigator
Role Name Email Phone Street address
Public Enquiries Elizabeth Stanley Batchilly esbatchilly@mrc.gm +2204495444 Atlantic Road
City Postal code Country Position/Affiliation
Fajara near Banjul Gambia Head of Governance and Research Support Services
Role Name Email Phone Street address
Scientific Enquiries Ed Clarke eclarke@mrc.gm +2204495443 Atlantic Road
City Postal code Country Position/Affiliation
Fajara near Banjul Gambia Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes ‘A summary of the trial results, based on the clinical study report and/or peer reviewed publication will be provided within 12 months of study completion as expected’ Study Protocol within 12 months of study completion The study data will be stored in a limited access, password protected database so that only staff who have the required permissions can view the study records
URL Results Available Results Summary Result Posting Date First Journal Publication Date
when results available No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information