Clinical trial NCT05193279: Safety and Immunogenicity of SCB-2019 in Children <18 Years of Age
Official title: A Randomized, Controlled, Dose-finding, Observer-blind, Phase 2/3 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of CpG/Alum-adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccines (SCB-2019 Vaccine) in Children <18 Years of Age
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: COVID-19
Lead sponsor: Clover Biopharmaceuticals, Ltd
Sponsor class: INDUSTRY
First posted: 2022-01-14
Enrollment: 0
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a phase 2/3, randomized, controlled study to assess the reactogenicity, safety and immunogenicity of adjuvanted recombinant SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019), when administered as 2-dose vaccination series in children below 18 years of age.


Eligibility criteria: Inclusion Criteria:

* Male or female \<18 years of age. Participants will be stratified into different age cohorts (≥12 to \< 18 years, ≥5 to \< 12 years, ≥2 to \< 5 years, and \< 2 years of age) based on the age on the day of inclusion.
* Individuals and their legally authorized representative (LAR) are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.
* Individuals are willing and able to give an assent (if applicable) and their LARs are willing and able to give informed consent on their behalf, prior to screening
* Healthy participants (phase 2 and phase 3) or participants with pre-existing medical conditions who are in a stable medical condition (phase 2)
* For infants (\<1-year-old) - born at full term (gestational age ≥37 weeks) and with a normal birth weight (≥2500 grams).
* Female participants of childbearing potential may be enrolled in the study, if the participant has practiced highly effective contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination and has agreed to continue adequate contraception for 3 months after the last vaccination

Exclusion Criteria:

* Individuals with fever \>38.0°C \[≥ 100.4°F\] (irrespective of method used), or any acute illness at baseline (Day 1) or within 3 days prior to randomization.
* Individuals with laboratory-confirmed SARS-CoV-2 infection \[as defined by Rapid COVID Antigen Test or an equivalent at Day 1\] or with history of laboratory-confirmed/medically-diagnosed COVID-19 (for phase 2 participants only).
* Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1, or plan to receive an investigational or licensed COVID-19 vaccine during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease \[e.g., malignancy, human immunodeficiency virus (HIV) infection\] or immunosuppressive/cytotoxic therapy (e.g., systemic corticosteroids, medications used for cancer chemotherapy, organ transplantation or to treat autoimmune disorders) within 3 months prior to Day 1. Inhaled, intranasal, topical steroids as well as a single dose of systemic steroids, are allowed.
* Individuals with any progressive or severe neurologic disorder, seizure disorder (including febrile seizures) or history of Guillain-Barré syndrome.
* Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period.
* Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction
* Individuals who have received any other investigational product within 30 days prior to Day 1 or intend to participate in another clinical study at any time during the conduct of this study.
* Individuals who have received any other licensed vaccines within 14 days prior to enrollment in this study or who are planning to receive any vaccine up to 28 days after the second (phase 2) or third (phase 3) vaccination.
* Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular injection
* Administration of intravenous immunoglobulins and/or any blood products within 3 months prior to enrollment or planned administration during the study period
* Individuals with any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant

Primary outcomes:
measure: Phase 2, select optimal dose level of SCB-2019 vaccine by age cohort (5-11 years, 2-4 years, and < 2 years), based on safety
timeFrame: 7 days after dose 1 (Day 1-7)
measure: Phase 2, select optimal dose level of SCB-2019 vaccine by age cohort (5-11 years, 2-4 years, and < 2 years), based on safety
timeFrame: 7 days after dose 2 (Day 22-28)
measure: Phase 2, select optimal dose level of SCB-2019 vaccine in phase 2 by age cohort (5-11 years, 2-4 years, and < 2 years), based on immunogenicity
timeFrame: Day 36
measure: Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 5 to < 12 years as compared to young adults (18 to < 25 years)
timeFrame: 21/15 days after second SCB-2019 dose
measure: Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 2 to < 5 years as compared to young adults (18 to < 25 years)
timeFrame: 21/15 days after second SCB-2019 dose
measure: Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants birth to < 2 years as compared to young adults (18 to < 25 years)
timeFrame: 21/15 days after second SCB-2019 dose
Secondary outcomes:
measure: Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 5 to < 12 years as compared to young adults (18 to < 25 years)
timeFrame: 21/15 days after second SCB-2019 dose
measure: Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 2 to < 5 years as compared to young adults (18 to < 25 years)
timeFrame: 21/15 days after second SCB-2019 dose
measure: Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants birth to < 2 years as compared to young adults (18 to < 25 years)
timeFrame: 21/15 days after second SCB-2019 dose
measure: In phase 2 and 3, GMT of SARS-CoV-2 nAb
timeFrame: Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)
measure: In phase 2 and 3, proportion of participants achieving seroconversion for SARS-CoV-2 nAb
timeFrame: Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)
measure: In phase 2 and 3, GMFR in SARS-CoV-2 nAb
timeFrame: Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)
measure: In phase 2 and 3, proportion of participants with SARS-CoV-2 nAb above a certain threshold
timeFrame: Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)
measure: In phase 2 and 3, GMT of SCB-2019 Binding Antibody
timeFrame: Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)
measure: In phase 2 and 3, proportion of participants achieving seroconversion for SCB-2019 binding antibody
timeFrame: Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)
measure: In phase 2 and 3, GMFR of SCB-2019 binding antibody
timeFrame: Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)
measure: In phase 2 and 3, proportion of participants with SCB-2019 binding antibody above a certain threshold
timeFrame: Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)
measure: In phase 3, reactogenicity of the vaccine as indicated by the occurrence of solicited local and systemic reactions
timeFrame: 7 days after dose 1 (Day 1-7), dose 2 (Day 22-Day 28) and Dose 3 (Day 43-49)
measure: Phase 2 and 3, safety of the vaccine in terms of occurrence of unsolicited adverse events
timeFrame: Up to 21 days after the last vaccination
measure: Phase 2 and 3, safety of the vaccine in terms of occurrence of MAAEs, SAEs, adverse events leading to discontinuation from study, and AESIs.
timeFrame: During the entire study period
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Clínica de la Costa Ltda
city: Cali
country: Colombia
facility: Centro de Estudios en Infectología Pediátrica S.A.S. - CEIP S.A.S.
Study officials:
References: