HPV Vaccination in Africa- New Delivery Schedules Alias The HANDS HPV Vaccine Trial

NCT03832049 | Unknown Phase 3 DMC

• 1 other identifier: SCC 1597
• Study Type: interventional
• Target: 1,720
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, observer-blind non-inferiority trial to evaluate alternative human papillomavirus (HPV) vaccination schedules in young females in West Africa.

Conditions

Human Papillomavirus Vaccine

Keywords

HPV vaccination in healthy females

Outcome Measures

Primary Outcomes (14)

• Antibodies measured by 9-valent HPV competitive Luminex immunoassay (cLIA) (mMU/mL)

  HPV types, 6, 11, 16, 18, 31, 33, 45, 52 and 58

  4 weeks after last vaccine dose

• Acute allergic reaction (Grade 0 - 4)

  Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds

  Day of vaccination (day 0)

• Injection site pain (Grade 0 - 4)

  Solicited local reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds

  Days 0 to 6 after vaccination

• Injection site redness (Grade 0 - 4)

  Solicited local reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds

  Days 0 to 6 after vaccination

• Injection site swelling (Grade 0 - 4)

  Solicited local reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds

  Days 0 to 6 after vaccination

• Injection site pruritus (Grade 0 - 4)

  Solicited local reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds

  Days 0 to 6 after vaccination

• Temperature in degrees Centigrade

  Recorded in 4 to 8 year olds and 9 to 14 year olds

  Days 0 to 6 after vaccination

• Nausea/vomiting (Grade 0 - 4)

  Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds

  Days 0 to 6 after vaccination

• Headaches (Grade 0 - 4)

  Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds

  Days 0 to 6 after vaccination

• Dizziness (Grade 0 - 4)

  Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds

  Days 0 to 6 after vaccination

• Fatigue (Grade 0 - 4)

  Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds

  Days 0 to 6 after vaccination

• Myalgia/arthralgia (Grade 0 - 4)

  Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds

  Days 0 to 6 after vaccination

• Unsolicited adverse event (AE) including serious adverse events

  Unsolicited AE will be recorded in 4 to 8 years olds and 9 to 14 year olds

  Day 0 to day 28 following each vaccination

• Suspected unexpected serious adverse reactions (SUSAR)

  SUSAR will be collected from all participants

  Day 0 to month 36

Secondary Outcomes (7)

• Antibodies measured by 9-valent HPV cLIA (mMU/mL)

  12 months after first vaccination

• Antibodies measured by 9-valent HPV cLIA (mMU/mL)

  24 months after first vaccination

• Antibodies measured by 9-valent HPV cLIA (mMU/mL)

  36 months after first vaccination

• Antibodies measure by 9-valent HPV total IgG (TIgG)

  4 weeks after last vaccine dose

• Antibodies measure by 9-valent HPV TIgG

  12 months after first vaccination

Study Arms (5)

15 to 26 years - 3 dose

ACTIVE COMPARATOR

9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses

Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses

9 to 14 years - 2 dose

EXPERIMENTAL

9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses

Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses

4 to 8 years - 2 dose

EXPERIMENTAL

9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses

Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses

9 to 14 years - 1 dose

EXPERIMENTAL

9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose

Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose

4 to 8 years - 1 dose

EXPERIMENTAL

9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose

Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose

Interventions

9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses BIOLOGICAL

0.5mL intramuscular dose - 3 doses (0, 2 and 6 months)

15 to 26 years - 3 dose

9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses BIOLOGICAL

0.5mL intramuscular dose - 2 doses (0 and 6 months)

4 to 8 years - 2 dose; 9 to 14 years - 2 dose

9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose BIOLOGICAL

0.5mL intramuscular dose - 1 doses (0 months)

4 to 8 years - 1 dose; 9 to 14 years - 1 dose

Eligibility Criteria

• Age: 4 Years - 26 Years
• Gender Eligibility Details: Participant is of female sex (based on participant/parent self-report)
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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 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.
• 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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Public Health England: collaborator
• University of Cambridge: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Ed Clarke

Banjul, Outside U.S. and Canada, PO Box 273, The Gambia

Location

Related Publications (1)

• Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

  PMID: 41276263 DERIVED

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent

Study Officials

• Ed Clarke, MB ChB PhD

  Medical Research Council @ LSHTM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a randomized, open-label, single-centre, phase 3, noninferiority clinical trial of the Gardasil 9 vaccine

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: February 6, 2019
• Study Start: September 14, 2019
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

TH (1)