Strengthening HPV Immunization Through EPI Leveraged Delivery (SHIELD)

May 14, 2026 updated by: International Vaccine Institute

A Randomized, Observer-Blind, Placebo-Controlled, Proof-of-Concept Study to Assess the Safety, Tolerability and Immunogenicity of a Bivalent Human Papillomavirus (HPV) Vaccine in 9 and 15 Month Old Infants and Toddlers, 2-5 Year Old Children and an Open Label Single Dose Study in Young Unmarried Females Aged 15-20 Years in Ghana

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cervical cancer is a significant public health problem in Africa and a leading cause of cancer deaths in women. According to the WHO, Africa has the highest cervical cancer disease incidence and associated mortality in the world accounting for 19% of all global cases of cervical cancer and 23% of all cervical cancer related deaths. The high-risk Human Papillomavirus (HPV) Types16 and 18 are responsible for 70% of all global cervical cancers with a high prevalence of 22% in sub-Saharan Africa compared to a prevalence of 12%globally. The bivalent Cecolin HPV vaccine, manufactured by Innovax of China, has demonstrated >95% efficacy against HPV16/18 infections in women aged 18 to 26 years and some protection against HPV 31, 33 and 45. The hypothesis of this trial is that infants/toddlers vaccinated with the bivalent Cecolin will show similar safety, tolerability, and immunogenicity as compared to that observed in older age groups, 15 to 20year old, where efficacy has been established.

This trial is a proof-of-concept study to descriptively compare the safety, tolerability, and immunogenicity of HPV vaccination in a pediatric population. The aim is to demonstrate safety and tolerability, and that short-term immune responses in infants and toddlers are comparable to the responses in older girls and women between 15-20 years, an age group in whom efficacy has been shown. If the vaccines are shown to be safe, well tolerated, and sufficiently immunogenic in this pilot study, this would provide evidence to support larger statistically robust studies to test the safety, immunogenicity, longevity of immune response, and acceptability of including HPV vaccines in the routine EPI.

A total of one hundred and fifteen (N=115) eligible participants will be enrolled in the study with an age de-escalation approach for the pediatric cohort. First, the safety cohort of 15 children between the age of 2-5 years will be randomized in a 3:2 ratio to receive HPV (n=9) and placebo (n=6). To progress enrolment of toddlers aged 15 months, the DSMB will review safety data of the preceding safety cohort (2-5 years old) collected in the first week (until D7 visit) of follow-up according to pre-specified halting criteria. If halting criteria are not met, a further 15 toddlers (15 months) will be recruited similarly in a 3:2 ratio to receive HPV (n=9) and placebo (n=6). After the recruitment of the first 15 of 35 toddlers, there will be a second safety review by the DSMB. If halting criteria are not met, the remaining 20 participants of the 15-month-old cohort will continue recruitment. Following confirmation by the DSMB, 15 infants (9 months old) will be recruited similarly in a 3:2 ratio to receive HPV (n=9) and placebo (n=6). After the recruitment of the first 15 of 35 infants, there will be another safety review by the DSMB. If halting criteria are not met, the remaining 20 participants of the 9-month-old cohort will continue recruitment. The safety cohort and the toddlers will receive either a single dose of the HPV vaccine or placebo while the 9-month-old will either receive two doses of the HPV vaccine 6 months apart or the placebo. Adolescent girls and young women aged between 15 and 20 year olds will be recruited in open label study in parallel.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Ghana
      • Accra, Ghana
        • Recruiting
        • Dodowa Health Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion 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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm AS (2-5 years old)
HPV Vaccine
Biological: HPV vaccine
0.5 mL HPV Vaccine Injection Intramuscular
Placebo Comparator: Arm PS (2-5 years old)
Placebo
Biological: Placebo
0.5 mL Placebo injection intramuscular
Experimental: Arm A15 (15 months old)
HPV Vaccine
Biological: HPV vaccine
0.5 mL HPV Vaccine Injection Intramuscular
Biological: Measles and rubella Vaccine
Measles and rubella Vaccine according to EPI
Placebo Comparator: Arm P15 (15 months old)
Placebo
Biological: Placebo
0.5 mL Placebo injection intramuscular
Biological: Measles and rubella Vaccine
Measles and rubella Vaccine according to EPI
Experimental: Arm A9 (9 months old)
HPV + MR Vaccine
Biological: HPV vaccine
0.5 mL HPV Vaccine Injection Intramuscular
Biological: Measles and rubella Vaccine
Measles and rubella Vaccine according to EPI
Placebo Comparator: Arm P9 (9 months old)
Placebo + MR Vaccine
Biological: Placebo
0.5 mL Placebo injection intramuscular
Biological: Measles and rubella Vaccine
Measles and rubella Vaccine according to EPI
Active Comparator: Arm E (15-20 years old)
HPV Vaccine (Open Label)
Biological: HPV vaccine
0.5 mL HPV Vaccine Injection Intramuscular

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and Reactogenicity of HPV Vaccination
Time Frame: 9 months post 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
Time Frame: At 1, 7, 12, and 24 months post-HPV vaccination
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
Time Frame: At 1, 7, 12, and 24 months post-HPV vaccination
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HPV16/18 Seroconversion Rate
Time Frame: 1 month and 7 months post HPV vaccination
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
1 month and 7 months post HPV vaccination
HPV16/18 VLP ELISA Antibody Titers by Age and Sex
Time Frame: At 1, 7, 12, and 24 months post-HPV vaccination
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).
At 1, 7, 12, and 24 months post-HPV vaccination
Geometric Mean Concentration of HPV16/18 Antibodies by Age Group
Time Frame: At 1, 7, 12, and 24 months post-HPV vaccination
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.
At 1, 7, 12, and 24 months post-HPV vaccination
Measles and Rubella Seroconversion Rate
Time Frame: 1 month post MR vaccination
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.
1 month post MR vaccination

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HPV16/18 Neutralizing Antibody Titers (PBNA)
Time Frame: Baseline, 1, 7, 12, and 24 months post HPV vaccination
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.
Baseline, 1, 7, 12, and 24 months post HPV vaccination
Geometric Mean Concentration of HPV16/18 Neutralizing Antibodies
Time Frame: Baseline, 1, 7, 12, and 24 months post HPV vaccination
Geometric mean concentration of neutralizing antibodies against HPV16 and HPV18 measured using PBNA, expressed as geometric mean neutralizing antibody titers.
Baseline, 1, 7, 12, and 24 months post HPV vaccination
Acceptability of HPV Vaccination in Infants and Toddlers
Time Frame: Up to 7 months post vaccination
Acceptability of HPV vaccination in infants and toddlers as reported by parents or caregivers and healthcare workers using structured questionnaires, summarized using questionnaire scores
Up to 7 months post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
International Vaccine Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karolinska Institutet
Noguchi Memorial Institute for Medical Research
Dodowa Health Research Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Julia Lynch, MD, International Vaccine Institute
  • Principal Investigator: George Armah, Prof. PhD, Noguchi Memorial Institute for Medical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 29, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IVI SHIELD 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HPV Vaccine

Clinical Trials on HPV vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings