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New treatment option for HPV Vaccine
Official title Strengthening HPV Immunization Through EPI Leveraged Delivery
ClinicalTrials.gov ID: NCT07377656
What this study is testing
What is HPV vaccine?
HPV vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for hpv vaccine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 to 20. Healthy volunteers may be eligible.
You may be able to join if
- 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).
- Unmarried females with a negative pregnancy test at screening practicing/willing to practice continuous effective contraception as recommended by the...
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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 how well it works 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
- Any underlying known condition or criteria, including acute or chronic clinically significant abnormality or infection that in the opinion of the...
See the full eligibility criteria
- 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).
- Unmarried females with a negative pregnancy test at screening practicing/willing to practice continuous effective contraception as recommended by the Ghana Health Services guidance in Ghana
- Able and willing to comply with all study requirements.
- Willingness to provide written informed consent before any trial procedure. Assent will be required for young female participants aged 15-17 years at vaccination in addition to their parent's/LAR's consent.
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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 how well it works 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
- Any underlying known condition or criteria, including acute or chronic clinically significant abnormality or infection that in the opinion of the investigator might compromise the wellbeing of the participant or...
- Administration of immunoglobulins and/ or any blood products within the three months preceding the administration of the study vaccine.
- Known history of allergy or anaphylaxis to study vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse reaction.
- Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within 3 months prior to recruitment...
- Any other finding that in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor-quality data.
The study team makes the final eligibility decision.
Where it's taking place
- Accra, Ghana
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 9 months to 20 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Accra, Ghana. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.