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Vaccines

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

vaccine COMIRNATY® (BNT162b2)

Arnaud PETIT, Pr

Matthieu RESCHE-RIGON, Pr

Arnaud Petit, Pr

Marion Strullu

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 12 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 (≥12-15 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.

Dose finding, stratified on the age group (≥1-\<2 years, ≥2-\<5 years, ≥5-\<12 years)

Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings

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.

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.

Increase in anti-Spike IgG will be defined as four times or more increase in anti-Spike IgG titer AND positive neutralizing test (from 1/5 dilution). The patient will be considered as having a " significant seroconversion " to vaccination if these 2 efficacy criteria are present

- If these 2 efficacy criteria are present, the patient is considered as having a " significant seroconversion " to vaccination

Positivity of SARS-CoV-2 PCR in nasopharynx in case of infection

Symptomatic SARS-CoV-2 infections will be defined by the presence of at least one symptom amongst fever, dyspnea, cough, chest pain, anosmia, ageusia, diarrhea or vomiting, AND a positive SARS-CoV-2 PCR,

Covid19 WHO scale in 10 items in case of infection Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by non-invasive ventilation (NIV) or High flow: 6 Intubation and Mechanical ventilation, pO2/Fraction of inspired oxygen (FIO2)\>=150 OR saturation by pulse oximetry (SpO2) SpO2/FIO2\>=200: 7 Mechanical ventilation, (pO2/FIO2\<150 OR SpO2/FIO2\<200) OR vasopressors (norepinephrine \>0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2\<150 AND vasopressors (norepinephrine \>0.3 microg/kg/min), OR Dialysis OR extracorporeal membrane oxygenation (ECMO): 9 Dead: 10

In case of infection in a vaccinated child, SARS-CoV-2 PCR of the household (contact cases) from the diagnosis and within 7 days of contact, depending on the contagion (if 1st PCR is negative)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings	NCT04969601	Acute Leukemia Acute Lymphobla... Acute Myeloid L...	vaccine COMIRNA...	1 Year - 15 Years	Assistance Publique - Hôpitaux de Paris
Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings	NCT04969601	Acute Leukemia Acute Lymphobla... Acute Myeloid L...	vaccine COMIRNA...	1 Year - 15 Years	Assistance Publique - Hôpitaux de Paris
Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings	NCT04969601	Acute Leukemia Acute Lymphobla... Acute Myeloid L...	vaccine COMIRNA...	1 Year - 15 Years	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for vaccine comirnaty® (bnt162b2)