A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.

Официальное название

A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children 1 to <12 Years of Age

Обзор

The goal of this multi-center, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity of CHIKV VLP Vaccine in children 1 to \<12 years of age.

Вмешательства

• Биопрепарат CHIKV VLP vaccine
  CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%
• Биопрепарат Placebo
  Placebo is comprised of formulation buffer

Первичные конечные точки

• Safety Endpoint 3: Incidence of AESI, MAAEs, and SAEs [Срок оценки: From vaccination through the end of the trial, planned to be Day 732 for study completers.]
• Primary Immunogenicity Endpoint: Day 22 anti-CHIKV SNA seroresponse rate in seronegative children [Срок оценки: Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.]
• Safety Endpoint 2: Incidence of unsolicited AEs through Day 29 [Срок оценки: From vaccination on Day 1 through Day 29, 28 days after vaccination with CHIKV VLP vaccine or placebo.]

Вторичные конечные точки (11)

• Key Secondary Immunogenicity Endpoint 2: Day 22 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children [Срок оценки: Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.]
• Secondary Immunogenicity Endpoint 1: Day 15 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children [Срок оценки: Study Day 15, 14 days after vaccination with CHIKV VLP vaccine or placebo.]
• Safety Endpoint 1: Incidence of solicited adverse events through Day 8 [Срок оценки: From vaccination on study Day 1 through Day 8, 7 days after vaccination with CHIKV VLP vaccine or placebo.]
• Key Secondary Immunogenicity Endpoint 1: Day 15 anti-CHIKV SNA seroresponse rate in seronegative children [Срок оценки: Study Day 15, 14 days after vaccination with CHIKV VLP vaccine or placebo.]
• Secondary Immunogenicity Endpoint 2: Day 183 and Day 366 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children [Срок оценки: Study Day 183 and Day 366, 182 and 365 days after vaccination with CHIKV VLP vaccine or placebo, respectively.]
• Secondary Immunogenicity Endpoint 3: Day 15, Day 22, Day 183, and Day 366 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children [Срок оценки: Day 15, Day 22, Day 183, and Day 366, 14, 21, 182, and 365 days after vaccination with CHIKV VLP vaccine or placebo, respectively.]
• Secondary Immunogenicity Endpoint 4: GMTs of anti-CHIKV SNA at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only [Срок оценки: Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.]
• Secondary Immunogenicity Endpoint 5a: GMFIs from Day 1 to Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only [Срок оценки: Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.]
• Secondary Immunogenicity Endpoint 5b: Frequency of participants with titer ≥15 and 4-fold rise over baseline at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for the CHIKV VLP vaccine group only [Срок оценки: Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.]
• Secondary Immunogenicity Endpoint 6: Anti-CHIKV SNA seroresponse rates at Day 732 in the CHIKV VLP vaccine group only [Срок оценки: Study Day 732, 731 days after vaccination with CHIKV VLP vaccine.]
• Secondary Immunogenicity Endpoint 7: Day 22 anti-CHIKV SNA seroresponse rate between seronegative children in the IEP versus adolescents and adults study EBSI-CV-317-004 [Срок оценки: Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.]

Критерии участия

Критерии включения

• Males or females between 1 and <12 years of age at Day 1 (day of vaccination). Note: Screening should only occur in the active/open cohorts. Please see Section 6.1 for details
• Body weight ≥6.5 kg.
• In general good health, in the opinion of the investigator, based on medical history and physical examination.
• Able and willing to provide informed assent for study participation and primary caregiver is able and willing to provide informed consent for study participation, in accordance with the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) determination and applicable federal and local regulations and guidelines.
• Able and willing to complete all scheduled visits and comply with all study procedures.

Критерии исключения

• Participation or planned participation in an investigational clinical study (eg, vaccine, drug) within 30 days before Day 1 and for the duration of the study. Note: Participation in an observational study or follow-up phase of a study may be allowed; these instances should be discussed with the sponsor's medical monitor and written agreement obtained prior to enrollment.
• Current acute illness, with or without fever.
• Current or recent CHIKV infection indicated by positive immunoglobulin M (IgM) and negative immunoglobulin G (IgG) rapid diagnostic test (RDT) results at screening in the Philippines only; participants in the US will not be tested using the RDT.
• History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product.
• History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to vaccination.
• Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from 180 days prior to screening through Day 22. Note: Systemic corticosteroid use at a dose or equivalent dose of 20 mg or greater (≥0.5 mg/kg for children <40 kg) of prednisone for 14 consecutive days or more within 90 days of screening through Day 22 is exclusionary. The use of inhaled, intranasal, topical, or ocular steroids is allowed.
• Receipt or anticipated receipt of immunoglobulin from 180 days prior to screening through the duration of the study.
• Any administration or planned administration of:

• A licensed live attenuated vaccine within 28 days before administration of investigational product and until Visit 2 (Day 15 or 22, as applicable) has occurred.
• Other licensed (not live) vaccine within 14 days before administration of investigational product and until Visit 2 (Day 15 or 22, as applicable) has occurred.
• Another licensed or investigational CHIKV vaccine.
• Known infection with human immunodeficiency virus, hepatitis C virus (HCV), or hepatitis B virus. Note: Positive anti-HCV antibodies and negative HCV polymerase chain reaction would NOT be exclusionary. Polymerase chain reaction testing will not be performed as part of this protocol.
• Bleeding disorder or receipt of anticoagulants in the 21 days before Day 1, contraindicating intramuscular vaccination, as judged by the investigator.
• Receipt or anticipated receipt of blood products from 90 days before Day 1 through the duration of the study.
• Onset of menarche prior to study vaccination.
• Planned medical or surgical procedure that could adversely impact the participant's participation or the conduct of the study.
• Identified as an immediate family member of the investigator or employee with direct involvement in the study. Bavarian Nordic staff members and their families, contractors, agents, business partners, and anyone with a financial interest in the outcome of the study.
• Any other medical condition, including severe malnutrition, that, in the opinion of the investigator, could adversely impact the participant's participation or conduct of the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

США · 8 центров

• ARK Clinical Research, LLC — Fountain Valley
• Emerson Clinical Research Institute- DC — Washington D.C.
• Acevedo Clinical Research — Miami
• Hope Research Network — Miami
• Velocity Clinical Research-Omaha — Omaha
• Cincinnati Children's Hospital Medical Center — Cincinnati
• KidCare Pediatrics — Beaumont
• Velocity Clinical Research - Salt Lake City — West Jordan

Филиппины · 6 центров

• CARE CT Group Inc. — Dasmariñas
• HIMC Research and Development on Medical Sciences — Imus
• Silang Specialist Medical Center — Silang
• University of Perpetual Help DALTA Medical Center, Biomedical Research Institute — Las Piñas
• Institute of Child Health and Human Development, University of the Philippines — Manila
• University of the Philippines-Philippine General Hospital — Manila

Пуэрто-Рико · 1 центр

• CMRC Headlands LLC — San Juan

Публикации

• Bennett SR, McCarty JM, Ramanathan R, Mendy J, Richardson JS, Smith J, Alexander J, Ledgerwood JE, de Lame PA, Royalty Tredo S, Warfield KL, Bedell L. Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial. Lancet Infect Dis. 2022 Sep;22(9):1343-1355. doi: 10.1016/S1473-3099(22)0022 PMID 35709798
• McCarty JM, Bedell L, Mendy J, Coates EE, Chen GL, Ledgerwood JE, Tredo SR, Warfield KL, Richardson JS. Chikungunya virus virus-like particle vaccine is well tolerated and immunogenic in chikungunya seropositive individuals. Vaccine. 2023 Oct 6;41(42):6146-6149. doi: 10.1016/j.vaccine.2023.08.086. Epub 2023 Sep 9. PMID 37690874
• Richardson JS, Anderson DM, Mendy J, Tindale LC, Muhammad S, Loreth T, Tredo SR, Warfield KL, Ramanathan R, Caso JT, Jenkins VA, Ajiboye P, Bedell L; EBSI-CV-317-004 Study Group. Chikungunya virus virus-like particle vaccine safety and immunogenicity in adolescents and adults in the USA: a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025 Apr 19;405(10487):1343-1352. doi: 1 PMID 40158526

Идентификаторы

NCT: NCT07003984 · EBSI-CV-317-006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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