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PACIFIC
Anti-Covid-19 Vaccine Protection in Immunocompromised Children (1 to 15 Years Old) With Acute Leukemia and Their Siblings (≥12 Years Old). Phase I-II Trial Evaluating Post-vaccine Safety and Humoral and Cellular Immunogenicity.
Sponsor study identifier
interventional
76
1 country
2
Study Start
September 29, 2021
Actual (reported)Primary Completion
February 28, 2022
Actual (reported)Study Completion
March 1, 2024
Actual (reported)Mortality in case of SARS-CoV-2 infection (Covid-19) during acute leukemia (AL) treatment is around 30%, i.e. more than 10 times the one of general population. Severe forms are reported in children receiving chemotherapy for AL. However, the main risk, largely underestimated, is related to delay in chemotherapy administration in case of infection, leading to an increased risk of relapse. Therefore, it is justified to propose an anti-Covid-19 vaccination to these patients. Vaccination of siblings also seems necessary given the uncertainty regarding vaccine response in children with AL and given that household is the main source of contamination. The messenger ribonucleic acid (mRNA) vaccine COMIRNATY® (BNT162b2) is already approved by health authorities for individuals older than 12. In immunocompromised children with AL, safety and efficacy data are unknown. The benefit/risk balance encourages to use the vaccine without health authority approval in children aged 1 to 15 with AL. Regarding household, parents are vaccinated for several months as standard of care, but vaccination will be proposed to siblings aged 5 to 15 years old in this protocol. The primary objective of this study is to evaluate safety and immunogenicity of COMIRNATY® (BNT162b2) vaccine (two injections 21-28 days apart) in children with acute leukemia (1 to 15 years old) and their siblings (5 to 15 years old). A secondary objective of the study is to compare the quality of humoral and cellular vaccine responses in children with AL and healthy children.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 19, 2021
Actual (reported)July 20, 2021
Actual (reported)September 29, 2021
Actual (reported)February 28, 2022
Actual (reported)March 1, 2024
Actual (reported)Dose limiting toxicity (DLT)
Dose limiting toxicity (DLT) defined by the presence within 7 days following vaccine injection of a grade ≥3 adverse event related to the vaccine. They are derived from CTCAE v5.0 and FDA guide " Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials ". Any other unexpected grade 3-4 clinical adverse event according to CTCAE v5.0 related to vaccination. A committee of critical events and DLTs surveillance will validate if declared grade 3-4 serious adverse events are related to vaccine.
within 7 days from first dose
co-primary endpoint: anti-Spike Immunoglobulin G (IgG) titer >= 260 BAU/mL
Quantitative detection of anti-spike antibodies by chemiluminescence technique
at 1 month from second dose
Anti-Spike IgG levels
between 21 and 28 days from first dose
Anti-Spike IgG levels
at 6 months from first dose
Anti-Spike IgG levels
at 12 months from the 1st dose
Anti-nucleocapsid IgG levels
between 21 and 28 days from the first dose
Anti-nucleocapsid IgG levels
6 months from the first dose
Two injections of COMIRNATY® (BNT162b2) vaccine 21-28 days apart
two injections of COMIRNATY® (BNT162b2) vaccine 21-28 days apart, of either 10, 20, 30 µg of vaccine, depending on the observed responses of previous children
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hôpital Armand Trousseau
Paris, 75012, France
Hôpital Robert Debré
Paris, 75019, France
76 participants (actual enrollment reported by the registry).
First Submitted
July 19, 2021
First Posted
July 20, 2021
Study Start
September 29, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
February 28, 2022
Actual (reported)Study Completion
March 1, 2024
Actual (reported)Last Updated
June 26, 2024
Record last verified: 2024-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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