A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers

Launched by CANSINO BIOLOGICS INC. · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new vaccine called VLP-Polio to see how safe it is and how well it works in preventing polio in infants and toddlers. The trial is divided into two phases: in the first phase, toddlers aged 12 to 18 months will receive one dose of either a high dose of the vaccine or a control vaccine (which does not contain the active ingredient) in a 3:1 ratio. For infants aged 6 weeks to 2 months, there will be four different groups receiving lower, medium, or high doses of the vaccine or the control vaccine. Each infant will get three doses of the assigned vaccine, spaced 28 days apart, and a booster dose when they are between 12 and 18 months old.

To participate, children must be healthy and have certain criteria met. For instance, toddlers should have completed their initial polio vaccinations, while infants should not have received any polio vaccines yet. Parents or guardians will need to give written consent, and children must be able to follow the study's requirements. Throughout the study, blood and other samples will be collected to check how well the vaccine works in building immunity against polio. This trial is currently not recruiting participants, but it aims to gather important information that could help protect young children from polio in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy toddlers aged 12-18 months at the time of screening, and have completed primary immunization of polio vaccine according to the national government program in the first year of life.
• • Healthy infants aged 6 weeks to 2 months (42 to 98 days, with the day of birth considered day of life 1), and who have not received any polio vaccines.
• • Able to obtain written informed consent from parent(s) or legal guardian(s).
• • Participants and their parents or legal guardian(s) can comply with trial procedures, are available for the duration of follow-up, and have a suitable telephone contact available.
• Exclusion Criteria:
• Exclusion criteria for the first dose:
• • Current polio disease or history of polio disease.
• • Toddlers who have an interval of less than 5 months since their last dose of the polio vaccine.
• • Infants born at \< 37 weeks of gestation.
• • Children with a birth weight \< 2500g and a body weight \< 3500g at the time of enrollment.
• • Body temperature ≥37.5°C (the visit may be rescheduled when this criterion is met).
• • Have congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
• • Any moderate or severe acute illness.
• • Any abnormal vital signs.
• • History of epilepsy, convulsions, or parent with congenital cognitive disability, dementia, or intellectual disabilities.
• • Have received immunosuppressive treatment, cytotoxic treatment, glucocorticoid treatment, etc. (excluding local treatment, surface treatment of acute non-concurrent dermatitis, or spray treatment of allergic rhinitis).
• • Received or plan to receive blood/plasma products or immunoglobulins throughout the study period or prior to study vaccination.
• • History of serious adverse events and/or severe allergic reactions (e.g., systemic allergic reactions) to any component of the study vaccine.
• • History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (e.g., thalassemia, coagulation factor deficiencies, severe anemia at birth).
• • Immunocompromised individuals with known or suspected immunodeficiency as determined by medical history and/or physical examination (e.g., history of pancreatic, liver, spleen, kidney disease or history of resection).
• • Administration of other vaccines within 7 days.
• • Participation in other interventional studies within 28 days prior to screening and/or during study participation.
• • Household member or sibling who has received or is scheduled to receive OPV in the previous 3 months until 5 weeks after the third dose of the primary immunization series.
• • The participant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the contract research organization (CRO), the investigator, or study site personnel.
• • History or current evidence of any condition or therapy which might confound the results of the study, interfere with the participant's participation for the full duration of the study, indicate suspected diseases, or is not in the best interest of the participants to participate, in the opinion of the treating investigator.
• • Family history of any medical conditions, that in the investigating doctor's opinion, could affect the trial outcomes.
• • Any reason or condition the investigator considers sufficient to make a participant ineligible for participation in the study.
• Exclusion criteria for the subsequent doses:
• • Severe allergic reaction after the previous vaccination.
• • Serious adverse events caused by the previous vaccination.
• • Newly identified symptoms or newly occurred cases after the first vaccination that do not meet the inclusion criteria for the first dose, or that meet the exclusion criteria for the first dose. The decision to discontinue participation is determined by the investigator.
• • Other reasons for exclusion considered by the investigating doctor .