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

Phase 1

• Conditions: - Children aged 1-15 years with LA undergoing chemotherapy or whose last chemotherapy session date is less than or equal to 12 months. - Siblings of children with LA (living in the same household > 50% of the time): 12-15 years old.; MedDRA version: 21.0Level: LLTClassification code 10000835Term: Acute leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2021-002966-41-FR
• Lead Sponsor: Assistance Publique – Hôpitaux de Paris / DRCI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-28
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified