Strengthening HPV Immunization Through EPI Leveraged Delivery

NCT07377656 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: IVI SHIELD 001
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HPV Vaccine

Keywords

HPV; Proof of concept; Ghana; SHIELD; IVI; International Vaccine Institute; Karolinska Institutet; Dodowa Health Research Center

Outcome Measures

Primary Outcomes (3)

• 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

  9 months post vaccination

• 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).

  At 1, 7, 12, and 24 months post-HPV vaccination

• 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.

  At 1, 7, 12, and 24 months post-HPV vaccination

Secondary Outcomes (4)

• HPV16/18 Seroconversion Rate

  1 month and 7 months post HPV vaccination

• HPV16/18 VLP ELISA Antibody Titers by Age and Sex

  At 1, 7, 12, and 24 months post-HPV vaccination

• Geometric Mean Concentration of HPV16/18 Antibodies by Age Group

  At 1, 7, 12, and 24 months post-HPV vaccination

• Measles and Rubella Seroconversion Rate

  1 month post MR vaccination

Other Outcomes (3)

• HPV16/18 Neutralizing Antibody Titers (PBNA)

  Baseline, 1, 7, 12, and 24 months post HPV vaccination

• Geometric Mean Concentration of HPV16/18 Neutralizing Antibodies

  Baseline, 1, 7, 12, and 24 months post HPV vaccination

• Acceptability of HPV Vaccination in Infants and Toddlers

  Up to 7 months post vaccination

Study Arms (7)

Arm AS (2-5 years old)

EXPERIMENTAL

HPV Vaccine

Biological: HPV vaccine

Arm PS (2-5 years old)

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Arm A15 (15 months old)

EXPERIMENTAL

HPV Vaccine

Biological: HPV vaccine; Biological: Measles and rubella Vaccine

Arm P15 (15 months old)

PLACEBO COMPARATOR

Placebo

Biological: Placebo; Biological: Measles and rubella Vaccine

Arm A9 (9 months old)

EXPERIMENTAL

HPV + MR Vaccine

Biological: HPV vaccine; Biological: Measles and rubella Vaccine

Arm P9 (9 months old)

PLACEBO COMPARATOR

Placebo + MR Vaccine

Biological: Placebo; Biological: Measles and rubella Vaccine

Arm E (15-20 years old)

ACTIVE COMPARATOR

HPV Vaccine (Open Label)

Biological: HPV vaccine

Interventions

HPV vaccine BIOLOGICAL

0.5 mL HPV Vaccine Injection Intramuscular

Arm A15 (15 months old); Arm A9 (9 months old); Arm AS (2-5 years old); Arm E (15-20 years old)

Placebo BIOLOGICAL

0.5 mL Placebo injection intramuscular

Arm P15 (15 months old); Arm P9 (9 months old); Arm PS (2-5 years old)

Measles and rubella Vaccine BIOLOGICAL

Measles and rubella Vaccine according to EPI

Arm A15 (15 months old); Arm A9 (9 months old); Arm P15 (15 months old); Arm P9 (9 months old)

Eligibility Criteria

• Age: 9 Months - 20 Years
• Gender Eligibility Details: For 15-20 years age group, only female participants will be enrolled. Other age groups (2-5 years old, 9 and 15 months old) both male and female participant will be enrolled.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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 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.

You may not qualify 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 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
• 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.
• 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 (topical steroids may be allowed).
• 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.

Sponsors & Collaborators

• Karolinska Institutet: collaborator
• Noguchi Memorial Institute for Medical Research: collaborator
• Dodowa Health Research Centre: collaborator
• International Vaccine Institute: lead

Study Sites (1)

Dodowa Health Research Center

Accra, Ghana

Location

MeSH Terms

Interventions

Papillomavirus Vaccines; Rubella Vaccine

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Julia Lynch, MD

  International Vaccine Institute

  STUDY DIRECTOR

• George Armah, Prof. PhD

  Noguchi Memorial Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Derick Kimathi, MBChB, PhD

CONTACT

+254 727161778; Derick.Kimathi@ivi.int

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study follows an age de-escalation approach for the pediatric cohort. In the observer-blind arm, children aged 2-5 years will be enrolled first. Enrollment of the subsequent age groups will proceed only after DSMB review and approval at each stage. Following the first DSMB review and approval, enrollment of a limited number of participants aged 15 months will begin. After the next DSMB review and approval, recruitment will proceed for a subset of the 9-month-old age group while continuing enrollment in the 15-month cohort. A further DSMB review and approval will determine whether enrollment of the remaining 9-month-old participants may continue. Meanwhile, the open-label cohort of participants aged 15-20 years will begin enrollment concurrently with the 2-5-year-old group.

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: January 30, 2026
• Study Start: January 16, 2026
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)