AzTrials
AzTrials

Acute LeukemiaPhase 1/2PACIFICNCT04969601

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

A Phase 1/2 study testing vaccine COMIRNATY® (BNT162b2) in people with Acute Leukemia and Acute Lymphoblastic Leukemia, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 1 year to 15 yearsHealthy volunteers can take part
What is being tested?
vaccine COMIRNATY® (BNT162b2)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
2 sitesFrance
Study dates
29 Sep 2021to 1 Mar 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Hôpital Armand Trousseau

    Paris, 75012

  • Hôpital Robert Debré

    Paris, 75019

Other trials in France

About this study

Official title: 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.

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.

Being tested
vaccine COMIRNATY® (BNT162b2)
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vaccine COMIRNATY® (BNT162b2)Biological

    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

Study groups in NCT04969601
Study groupRoleWhat they receive
Anti Covid with COMIRNATY® (BNT162b2) vaccineExperimentalTwo injections of COMIRNATY® (BNT162b2) vaccine 21-28 days apart
Receives: Biological: vaccine COMIRNATY® (BNT162b2)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: within 7 days from first dose

  2. co-primary endpoint: anti-Spike Immunoglobulin G (IgG) titer >= 260 BAU/mL

    Quantitative detection of anti-spike antibodies by chemiluminescence technique

    Measured: at 1 month from second dose

Secondary outcomes (20)

  1. Anti-Spike IgG levels

    Measured: between 21 and 28 days from first dose

  2. Anti-Spike IgG levels

    Measured: at 6 months from first dose

  3. Anti-Spike IgG levels

    Measured: at 12 months from the 1st dose

  4. Anti-nucleocapsid IgG levels

    Measured: between 21 and 28 days from the first dose

  5. Anti-nucleocapsid IgG levels

    Measured: 6 months from the first dose

  6. Anti-nucleocapsid IgG levels

    Measured: 12 months from the first dose

  7. Neutralization ability of anti-Spike IgG (in case of anti-Spike IgG detection)

    Measured: at 2 months from the first injection

  8. Neutralization ability of anti-Spike IgG (in case of anti-Spike IgG detection)

    Measured: at 6 months from the first injection

  9. Neutralization ability of anti-Spike IgG (in case of anti-Spike IgG detection)

    Measured: at 12 months from the first injection

  10. Anti-SARS-CoV-2 T cell specific response (Elispot)

    Measured: at 2 months after the first injection

  11. Anti-SARS-CoV-2 T cell specific response (Elispot)

    Measured: at 6 months after the first injection

  12. Anti-SARS-CoV-2 T cell specific response (Elispot)

    Measured: at 12 months after the first injection

  13. Positivity of SARS-CoV-2 polymerase chain reaction (PCR) in nasopharynx

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

    Measured: at 8 days

  14. Positivity of SARS-CoV-2 PCR in nasopharynx

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

    Measured: at 15 days

  15. Positivity of SARS-CoV-2 PCR in nasopharynx

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

    Measured: at 28 days from infection

  16. Rate of symptomatic SARS-CoV-2 infections

    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,

    Measured: within 12 months after vaccination

  17. Genotype of the SARS-CoV-2 variant in case of infection

    Measured: within 12 months after vaccination

  18. Time between chemotherapy planned date and effective date in case of infection

    Measured: within 12 months after vaccination

  19. Covid19 World Health Organization (WHO) progression scale

    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

    Measured: within 12 months after vaccination

  20. Incidence of SARS-CoV-2 of the household (contact cases)

    In case of infection in a vaccinated child

    Measured: within 12 months after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2021
  2. Study start29 Sep 2021
  3. Primary completion28 Feb 2022
  4. Study completion1 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Dose finding, stratified on the age group (≥1-\<2 years, ≥2-\<5 years, ≥5-\<12 years)
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04969601
Sponsor's protocol ID
APHP210639
Acronym
PACIFIC
Status last verified
Jun 2024
First submitted
19 Jul 2021
Last updated
26 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing vaccine COMIRNATY® (BNT162b2) in people with Acute Leukemia and Acute Lymphoblastic Leukemia, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT) (time frame: within 7 days from first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04969601.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in