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De klinische studie NCT07377656 (SHIELD) voor HPV-vaccin is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
Strengthening HPV Immunization Through EPI Leveraged Delivery (SHIELD) Fase 2 115 Vaccin Gerandomiseerd Placebo-gecontroleerd Open-label
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De klinische studie NCT07377656 (SHIELD) onderzoekt preventie bij HPV-vaccin. Deze Fase 2 interventioneel studie heeft de status nog niet rekruterend. De inclusie van 115 deelnemers begint op 16 januari 2026. De studie wordt geleid door International Vaccine Institute en de voltooiing is gepland op 31 december 2028. Laatste update op ClinicalTrials.gov: 30 januari 2026.
Beknopte samenvatting
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.
Uitgebreide beschrijving
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...Toon meer
Officiële titel
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
Aandoeningen
HPV-vaccinAndere studie-ID's
- SHIELD
- IVI SHIELD 001
NCT-ID
Startdatum (Werkelijk)
2026-01-16
Laatste update geplaatst
2026-01-30
Verwachte einddatum
2028-12-31
Inschrijving (Geschat)
115
Studietype
Interventioneel
FASE
Fase 2
Status
Nog niet rekruterend
Trefwoorden
HPV
Proof of concept
Ghana
SHIELD
IVI
International Vaccine Institute
Karolinska Institutet
Dodowa Health Research Center
Proof of concept
Ghana
SHIELD
IVI
International Vaccine Institute
Karolinska Institutet
Dodowa Health Research Center
Primaire doel
Preventie
Toewijzing
Gerandomiseerd
Interventiemodel
Sequentieel
Blindering
Viervoudig blind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelArm AS (2-5 years old) HPV Vaccine | HPV Vaccine 0.5 mL HPV Vaccine Injection Intramuscular |
Placebo-comparatorArm PS (2-5 years old) Placebo | PLACEBO 0.5 mL Placebo injection intramuscular |
ExperimenteelArm A15 (15 months old) HPV Vaccine | HPV Vaccine 0.5 mL HPV Vaccine Injection Intramuscular Measles and rubella Vaccine Measles and rubella Vaccine according to EPI |
Placebo-comparatorArm P15 (15 months old) Placebo | PLACEBO 0.5 mL Placebo injection intramuscular Measles and rubella Vaccine Measles and rubella Vaccine according to EPI |
ExperimenteelArm A9 (9 months old) HPV + MR Vaccine | HPV Vaccine 0.5 mL HPV Vaccine Injection Intramuscular Measles and rubella Vaccine Measles and rubella Vaccine according to EPI |
Placebo-comparatorArm P9 (9 months old) Placebo + MR Vaccine | PLACEBO 0.5 mL Placebo injection intramuscular Measles and rubella Vaccine Measles and rubella Vaccine according to EPI |
Actieve comparatorArm E (15-20 years old) HPV Vaccine (Open Label) | HPV Vaccine 0.5 mL HPV Vaccine Injection Intramuscular |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 | 1 month and 7 months post HPV vaccination |
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). | At 1, 7, 12, and 24 months post-HPV vaccination |
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. | At 1, 7, 12, and 24 months post-HPV vaccination |
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. | 1 month post MR vaccination |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Kind, Volwassene
Minimumleeftijd
9 Months
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja
- 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 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.
International Vaccine InstituteCentraal Contactpersoon
Contact: Derick Kimathi, MBChB, PhD, +254 727161778, [email protected]
1 Studielocaties in 1 landen
Dodowa Health Research Center, Accra, Ghana
George Enyimah Armah, Prof., Contact, +233 208 246513, [email protected]