Clinical trial • Phase IV • Oncology

VARICELLA VIRUS OKA STRAIN (LIVE, ATTENUATED) for Pediatric cancer

Phase IV trial of VARICELLA VIRUS OKA STRAIN (LIVE, ATTENUATED) for Pediatric cancer. 160 participants.

Overview

Phase IV trial in Sweden.

Recruits 160 paediatric patients.

Pregnancy Exclusion: Female participants with an ongoing pregnancy at diagnosis or during the study
Vulnerable Population: Children and adolescents 0-18 years are included. Consent requirement: "Oral and written information about the trial along with signed consent". Subject information and consent forms are provided for different age groups and guardians (documents for ages 6-11, 12-14, 15-18, versions for healthy volunteers, and a version for guardians are listed in the trial documents).

{"criterion_text":"- Children and adolescents (0-18.0 years) initiating cancer treatment through the childrens cancer centre in Gothenburg.\n- Vaccination status for measles and chickenpox before cancer treatment is known.\n- Oral and written information about the trial along with signed consent\n- Female participants of reproductive age with menarche who are sexually active must consent to using effective contraception and have a negative pregnancy test at the times of all vaccinations. (Effective contraception refers to combined preparations with estrogen and progesterone taken orally, intravaginal ring, known as the p-ring, or preparations used transdermally, such as the contraceptive patch. Contraception with progesterone taken orally, via injections, or implants such as the contraceptive implant. Intrauterine hormone-releasing coil or copper coil. Completed sterilization with blockage of both fallopian tubes. Sexual abstinence)"}

{"criterion_text":"- Known primary immunodeficiency.\n- Ongoing treatment with immunomodulatory or immunosuppressive agents\n- Patients planned for relapse therapy or stem cell transplantation (SCT)\n- Known contraindication to any of the proposed vaccines.\n- Female participants with an ongoing pregnancy at diagnosis or during the study\n- Ongoing breastfeeding."}

{"endpoint_text":"- Difference in VZ IgG antibody levels before and after revaccination against chickenpox","definition_or_measurement_approach":"Measured by IgG antibodies to VZV before and after vaccination; primary objective framed as proportion (%) of patients with protective level of VZ-IgG after vaccination compared to before vaccination."}
{"endpoint_text":"- Difference in measles IgG antibody level before and after revaccination against measles","definition_or_measurement_approach":"Measured by IgG antibodies to measles (morbilli) before and after vaccination; primary objective framed as proportion (%) of patients with protective morbilli-IgG level after vaccination compared to prior to vaccination."}

{"endpoint_text":"- Percentage of patients with immunity against chickenpox and measles before and after treatment measured in IgG","definition_or_measurement_approach":"Measured as percentage (%) immune patients using IgG serology before and after treatment."}
{"endpoint_text":"- Changes in cellmediated immunity (CMI) against chickenpox and measles before and after revaccination. Comparisons with a healthy control group.","definition_or_measurement_approach":"Assessment of cell-mediated immunity (CMI) changes pre- and post-revaccination with comparisons to a healthy control group (specific CMI assays not detailed in provided record)."}
{"endpoint_text":"- Differences in antibody levels and CMI between various diagnostic groups (leukemias, solid tumors), different age groups, low- vs. high-intensity treatment, and pre-immune versus non-immune groups","definition_or_measurement_approach":"Subgroup analyses comparing antibody levels and CMI across diagnostic groups, age groups, treatment intensity, and baseline immune status (measurement methods referenced above: IgG and CMI assessments)."}

Planned Sample Size: 160
Recruitment Window Months: 47
Consent Approach: Oral and written information provided and signed consent required ("Oral and written information about the trial along with signed consent"). Age-specific subject information and consent forms are available (documents for ages 6-11, 12-14, 15-18), there is a specific guardian/parent consent document, and versions exist for healthy volunteers.

Site Name: Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vastra Gotalandsregionen
Department Name: Children´s cancer centre
Contact Person Name: Torben Ek
Contact Person Email: torben.ek@vgregion.se

Investigational Product Name: MEASLES, COMBINATIONS WITH MUMPS AND RUBELLA, LIVE ATTENUATED
Active Substance: MEASLES VIRUS EDMONSTON-SCHWARZ STRAIN (LIVE, ATTENUATED); MUMPS VIRUS RIT 4385 STRAIN (LIVE, ATTENUATED); RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED)
Modality: Vaccine
Routes Of Administration: INTRAMUSCULAR INJECTION
Route: INTRAMUSCULAR INJECTION
Starting Dose: 0.5 ml
Maximum Dose: 1.0 ml

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