Strengthening HPV Immunization Through EPI Leveraged Delivery
ConditionHPV Vaccine
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age9-20
SponsorInternational Vaccine Institute
About this trial
This is a randomized observer-blind placebo-controlled proof-of-concept study with the aim to assess the safety and tolerability, and the immunogenicity of a bivalent HPV vaccine administered in healthy infants and toddlers (9- and 15-month-olds) comparing them to an immune-bridging population of 15-20-year-old unmarried females in an open label study in Ghana at the Dodowa Health Research Center.
Eligibility criteria
Qualifiers
Healthy male and female individuals aged 9 months, 15 months, 2-5 years and unmarried females aged 15-20 years at the time of vaccination
Participants aged 9 months, 15 months and 2-5 years who are up to date with their EPI vaccinations.
Residing within the area of the study and planning to stay for the study duration.
Participants that are HIV negative at screening (for the 9-15-month-olds a documented negative maternal ANC HIV screening).
Disqualifiers
Pregnancy, lactation, or intention to become pregnant during the vaccination phase through three months after the study vaccine dose
Previous vaccination against HPV (Only for the 15-20-year-old efficacy cohort)
Presence of malnutrition (weight-for-length z-score ≤-2SD median, per WHO published child growth standards)
Planning to migrate out of the study areas before the end of the study follow-up
Trial design
Treatments tested in this trial
- HPV vaccine
- Placebo
- Measles and rubella Vaccine
Treatment groups
115 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
International Vaccine Institute
Lead sponsor
Karolinska Institutet
Collaborator
Noguchi Memorial Institute for Medical Research
Collaborator
Dodowa Health Research Centre
Collaborator
Source ClinicalTrials.gov