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

Inclusion criteria

• Children aged 1 to 15 years old :

• With acute lymphoblastic leukemia undergoing chemotherapy (at least 2 weeks from the last injection of PEG-asparaginase) or for whom the last chemotherapy is less than or equal to 12 months
• OR With acute myeloid leukemia within 12 months from the end of treatment
• Healthy siblings aged 5 to 15 years old living in the same household than the child with AL more than 50% of the time
• Informed consent from parents
• Patient affiliated to health insurance
• For women of childbearing age :

• A negative blood test at the inclusion visit
• AND use of an effective contraceptive method at least at least 4 weeks prior to vaccination and until at least 12 weeks after the last vaccination

Exclusion criteria

• Documented SARS-CoV-2 infection ongoing or that occurred less than 2 months ago
• Known clinical allergy to polyethylene glycol (PEG)
• Platelet <50 Giga(G) G/L or neutrophils <0.5 G/L at time of vaccination
• Vaccination apart from influenza virus within 4 weeks from the 1st injection or planning to receive an approved vaccine 4 weeks after the last injection
• Vaccination against influenza virus within 14 days before first injection
• Any hemorrhagic trouble considered as a contraindication to intramuscular injection
• History of severe adverse event after a vaccine administration including anaphylaxis and associated symptoms such as rash, respiratory issues, angioedema and abdominal pain, or history of allergic reaction that could be exacerbated by a vaccine component
• Participant vaccinated against tuberculosis within the past year
• Participant ill or febrile (body temperature ≥38°C) in the previous 72 hours with symptoms suggesting the presence of COVID-19.
• Allergy to any component of the vaccine or history of severe allergy (anaphylactic type)
• Treatment received for Covid-19 infection (60 days prior to 1st injection).
• Known HIV, HCV or HBV infection.
• Use of experimental Ig, experimental monoclonal antibodies or convalescent anti-covid-19 serum within 90 days prior to study entry
• Pregnant, breast-feeding or positive pregnancy test at inclusion visit.
• Participation in a vaccination trial
• Participation in other research without investigator's consent research within 4 weeks prior to the inclusion visit and for the duration of the trial

Translated with DeepL.com (free version)