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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
HPV vaccine
Biological/Vaccine0.5 mL HPV Vaccine Injection Intramuscular
Placebo
Biological/Vaccine0.5 mL Placebo injection intramuscular
Measles and rubella Vaccine
Biological/VaccineMeasles and rubella Vaccine according to EPI
Treatment groups
115 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Arm AS (2-5 years old)Experimental treatment 1 intervention
Group B: Arm PS (2-5 years old)Placebo comparator 1 intervention
Group C: Arm A15 (15 months old)Experimental treatment 2 interventions
Group D: Arm P15 (15 months old)Placebo comparator 2 interventions
Group E: Arm A9 (9 months old)Experimental treatment 2 interventions
Group F: Arm P9 (9 months old)Placebo comparator 2 interventions
Group G: Arm E (15-20 years old)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Reactogenicity of HPV Vaccination
Occurrence of solicited and unsolicited adverse events following single-dose or two-dose HPV vaccination administered concomitantly with routine Expanded Programme on Immunization (EPI) vaccines, including Measles and Rubella (MR) vaccine, among infants aged 9 months, toddlers aged 15 months, and children aged 2-5 years. Results will be summarized as the number of participants experiencing adverse events
Time frame
9 months post vaccination2
HPV16/18 VLP ELISA Antibody Titers
HPV16 and HPV18 antibody levels measured using Virus-Like Particle (VLP) Enzyme-Linked Immunosorbent Assay (ELISA) in serum samples collected from participants who received one or two doses of HPV vaccine. Antibody levels are expressed as ELISA antibody titers (IU/mL).
Time frame
At 1, 7, 12, and 24 months post-HPV vaccination3
Geometric Mean Concentration of HPV16/18 Antibodies
Geometric mean concentration (GMC) of HPV16 and HPV18 antibodies measured using VLP ELISA in vaccinated participants, expressed as IU/mL.
Time frame
At 1, 7, 12, and 24 months post-HPV vaccinationSecondary outcomes
1
HPV16/18 Seroconversion Rate
Seroconversion rate of HPV16 and HPV18 antibodies measured using VLP ELISA, defined as the proportion of participants who change from seronegative at baseline to seropositive after HPV vaccination. Results are expressed as a percentage of participants
Time frame
1 month and 7 months post HPV vaccination2
HPV16/18 VLP ELISA Antibody Titers by Age and Sex
HPV16 and HPV18 antibody titers measured using VLP ELISA among male and female infants and toddlers aged 9 and 15 months and children aged 2-5 years following HPV vaccination, expressed as ELISA antibody titers (IU/mL).
Time frame
At 1, 7, 12, and 24 months post-HPV vaccination3
Geometric Mean Concentration of HPV16/18 Antibodies by Age Group
Geometric mean concentration (GMC) of HPV16 and HPV18 antibodies measured using VLP ELISA among infants, toddlers, and children receiving HPV vaccination, expressed as IU/mL.
Time frame
At 1, 7, 12, and 24 months post-HPV vaccination4
Measles and Rubella Seroconversion Rate
Seroconversion rate of Measles and Rubella antibodies measured one month after MR vaccination among 9- and 15-month-old infants and toddlers who received MR vaccine with or without concomitant HPV vaccination. Results are expressed as a percentage of participants.
Time frame
1 month post MR vaccinationOther outcomes
1
HPV16/18 Neutralizing Antibody Titers (PBNA)
Neutralizing antibody titers against HPV16 and HPV18 measured using a pseudovirion-based neutralization assay (PBNA) in participants who received one or two doses of HPV vaccine. Results are expressed as neutralizing antibody titers.
Time frame
Baseline, 1, 7, 12, and 24 months post HPV vaccination2
Geometric Mean Concentration of HPV16/18 Neutralizing Antibodies
Geometric mean concentration of neutralizing antibodies against HPV16 and HPV18 measured using PBNA, expressed as geometric mean neutralizing antibody titers.
Time frame
Baseline, 1, 7, 12, and 24 months post HPV vaccination3
Acceptability of HPV Vaccination in Infants and Toddlers
Acceptability of HPV vaccination in infants and toddlers as reported by parents or caregivers and healthcare workers using structured questionnaires, summarized using questionnaire scores
Time frame
Up to 7 months post vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
International Vaccine Institute
Lead sponsor
Karolinska Institutet
Collaborator
Noguchi Memorial Institute for Medical Research
Collaborator
Dodowa Health Research Centre
Collaborator
Source ClinicalTrials.gov