Anti-Covid-19 vaccine protection in immunocompromised children (1-15 years) with acute leukemia and their siblings (= 12 years). Phase I-II trial evaluating safety and post-vaccination humoral and cellular immunogenicity / PACIFIC STUDY - PACIFIC

Assistance Publique – Hôpitaux de Paris / DRCI0 个研究点目标入组 150 人开始时间: 2021年6月28日最近更新: 2021年8月24日

试验速览

暂无简介。

•- Children 1-15 years of age:
•With acute lymphoblastic leukemia undergoing chemotherapy (minimum 2 weeks after the last PEG-ASPARAGINASE injection) or whose last chemotherapy is less than or equal to 12 months.
•With acute myeloid leukemia within 12 months after the end of treatment
•- Brother or sister between 12 and 15 years of age living in the same household as the child with ALL more than 50% of the time
•- Informed consent of parents
•- Patient affiliated to a social security plan
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 150
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Documented SARS-CoV-2 infection in progress or within the last three months
•- Known clinical allergy to polyethylene glycol (PEG)
•- Pregnant in the first trimester or breastfeeding
•- Platelet count < 50 G/L or PNN count < 0.5G/L at time of vaccination
•- Vaccinated within 4 weeks prior to the first injection or scheduled to receive a licensed vaccine 4 weeks after the last injection.
•- Any bleeding disorder considered a contraindication to intramuscular injection
•- History of severe adverse events following vaccine administration including anaphylactic reaction and associated symptoms such as rash, difficulty breathing, angioedema, and abdominal pain, or a history of allergic reaction that may be exacerbated by a vaccine component
•- Participant who has been vaccinated with BCG within the past year.

发起方

Assistance Publique – Hôpitaux de Paris / DRCI