Urological and Genital Diseases
Conditions
Interventions
Recombinant Human Papillomavirus Bivalent Vaccine with marketed brand name Cecolin
Normal Saline
Sponsors
International Vaccine Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria The study will include participants that meet the following criteria: 1. 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 2. Participants aged 9 months, 15 months and 2-5 years who are up to date with their EPI vaccinations. 3. Residing within the area of the study and planning to stay for the study duration. 4. Participants that are HIV negative at screening (for the 9–15-month-olds a documented negative maternal ANC HIV screening). 5. 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 6. Able and willing to comply with all study requirements. 7. 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.
Exclusion criteria
Exclusion criteria: Exclusion Criteria An individual who meets any of the following criteria will be excluded from participation in this study: 1. Pregnancy, lactation, or intention to become pregnant during the vaccination phase through three months after the study vaccine dose 2. Previous vaccination against HPV (Only for the 15–20-year-old efficacy cohort) 3. Presence of malnutrition (weight-for-length z-score =-2SD median, per WHO published child growth standards) 4. Planning to migrate out of the study areas before the end of the study follow-up 5. 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 interfere with the outcome of the study. 6. Administration of immunoglobulins and/ or any blood products within the three months preceding the administration of the study vaccine. 7. 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. 8. 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 (topical steroids may be allowed). 9. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of administering one or two doses of the HPV vaccine to 9- and 15-month-old infants/toddlers concomitantly with the routine EPI Measles containing vaccine. ;Descriptive comparison of SCR and GMC of HPV16 and 18 antibodies using PBNA 16/18, and VLP ELISA 16/18 at 1 and 7 months post the first dose among 15-20-year-old unmarried females and 9- and 15-month-old toddlers receiving either one or two doses of the HPV vaccine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Descriptive comparison of the SCR of measles and rubella antibodies one-month post-MR vaccine between 9- and 15-month-old infants/toddlers who did or did not receive a concomitant HPV vaccine. ;A qualitative rapid ethnographic study report that explores parent/caregivers’ as well as health care workers’ perceptions and experiences of HPV vaccine administration to an infant/toddler | — |
Countries
Ghana
Contacts
Public ContactDerick;Derick Kimathi;Kimathi
Protocol Principal Investigator;Protocol Principal Investigator
Outcome results
None listed