Vaccine Response After Cancer Therapy in Pediatric Patients
Recruiting in Palo Alto (17 mi)
Overseen byAshley Hinson, MD
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Atrium Health
Disqualifiers: Immunodeficiency, Pregnancy, Severe infection, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?Pediatric cancer survivors have increased infection-related morbidity and mortality. This study will evaluate immune dysfunction following cancer directed systemic therapy completion, with attention to clinical relevance and infection rate in this population compared to healthy siblings, when applicable. The investigators will also restart vaccinations at earlier time points than previously studied, at 3 months post therapy, and will assess whether boosters or revaccination schedules are superior for regaining immunity against potentially serious infections in survivors.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the treatment Vaccine in pediatric cancer patients?
Research shows that pediatric cancer patients can develop protective immune responses to vaccines, such as the influenza and COVID-19 vaccines, even after cancer treatment. For example, a study found that revaccinating children after cancer treatment led to protective antibody levels, and another study showed that a significant number of children responded well to the COVID-19 vaccine.
12345Is the vaccine safe for children who have undergone cancer therapy?
The safety of giving vaccines to children who have had cancer treatment is generally well-documented for inactivated vaccines (vaccines made from killed viruses or bacteria), but live vaccines (made from weakened viruses) can cause illness in these children. It's important to weigh the risks and benefits of live vaccines in this group.
26789How does the vaccine treatment differ from other treatments for pediatric cancer patients?
This vaccine treatment is unique because it focuses on assessing the immune response in pediatric cancer patients after receiving COVID-19 vaccinations, which is not commonly studied. It evaluates both antibody and T-cell responses, providing insights into how well these patients can develop immunity after cancer therapy.
234510Eligibility Criteria
This trial is for pediatric cancer survivors aged 2-21 who've finished their cancer therapy within the last 60 days. They should be able to perform daily activities (with some assistance if needed) and comply with study procedures. It's not for those treated only with surgery or radiotherapy, with severe vaccine allergies, immune deficiencies, pregnancy, or active severe infections.Inclusion Criteria
Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian
My cancer was confirmed by tests and is being treated by Levine Children's Hospital.
I have had cancer before and received at least one round of treatment for it.
+4 more
Exclusion Criteria
My cancer was treated with only surgery, radiation, or monitoring.
You have had a serious allergic reaction to a vaccine or any of its ingredients in the past.
I do not have a severe infection right now.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Lab evaluations for immune function at baseline
1 visit
1 visit (in-person)
Vaccination Phase
Participants receive either single booster vaccines or a full revaccination series starting at 3 months post therapy
3-9 months
3 visits (in-person) at 3, 6, and 9 months
Follow-up
Participants are monitored for immune response and infection rates at 12 and 24 months post therapy
24 months
2 visits (in-person) at 12 and 24 months
Participant Groups
The study evaluates how well pediatric cancer survivors' immune systems work after treatment and how they respond to vaccinations given earlier than usual—at just 3 months post therapy. The goal is to see if this timing or revaccination can better protect against serious infections.
2Treatment groups
Experimental Treatment
Group I: Arm B - Staged revaccination seriesExperimental Treatment1 Intervention
Those subjects randomized to Arm B, the full revaccination series, will receive applicable vaccines when titers are low (below normal range) at baseline. When indicated, non-live vaccines will be given at the 3, 6, and 9 month visits, live vaccines will be given at the 6 and 9 month visit. Subjects who have negative/undetectable titers to any vaccine at the 24 month visit will receive boosters to each applicable vaccine.
Group II: Arm A - Single booster vaccinesExperimental Treatment1 Intervention
Those subjects randomized to Arm A, single dose vaccine boosters, will receive non live vaccine boosters at the 3 month visit. Boosters for live vaccines will be given at the 6 month visit. Boosters will only be given as applicable for low titers tested at the baseline assessment visit. Subjects who have negative/undetectable titers to any vaccine at the 24 month visit will receive boosters to each applicable vaccine.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Levine Cancer InstituteCharlotte, NC
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Who Is Running the Clinical Trial?
Atrium HealthLead Sponsor
Wake Forest University Health SciencesLead Sponsor
Atrium Health Levine Cancer InstituteCollaborator
References
Assessment of the immune response to trivalent split influenza vaccine in children with solid tumors. [2009]To assess the immune response to influenza vaccine in children with solid tumors receiving chemotherapy or under the influence of chemotherapy.
Dynamic re-immunization of off-treatment childhood cancer survivors: An implementation feasibility study. [2018]There are no universally approved re-vaccination guidelines for non-transplant pediatric cancer survivors. We hypothesized that by utilizing a response-based re-vaccination schedule, we could tailor vaccine schedules in off-treatment cancer survivors. Pre-vaccination antibody levels were obtained in 7 patients at an average of 20 days after the end of treatment date. In those without protective antibody levels, we administered vaccines 3 months after completion of treatment. Revaccinating patients 3 months after the end of treatment date resulted in protective antibody levels for most vaccines. We showed, on a preliminary basis, that vaccinating non-transplanted pediatric cancer survivors can be dynamically implemented in children with recovering immune function.
Immune Response following BNT162b2 mRNA COVID-19 Vaccination in Pediatric Cancer Patients. [2023]COVID-19 vaccinations are recommended for children with cancer but data on their vaccination response is scarce. This study assesses the antibody and T-cell response following a 2- or 3-dose vaccination with BNT162b2 mRNA COVID-19 vaccine in children (5-17 years) with cancer. For the antibody response, participants with a serum concentration of anti-SARS-CoV-2 spike 1 antibodies of >300 binding antibody units per milliliter were classified as good responders. For the T-cell response, categorization was based on spike S1 specific interferon-gamma release with good responders having >200 milli-international units per milliliter. The patients were categorized as being treated with chemo/immunotherapy for less than 6 weeks (Tx 6 weeks) before the first immunization event. In 46 patients given a 2-dose vaccination series, the percentage of good antibody and good T-cell responders was 39.3% and 73.7% in patients with Tx 6 weeks, respectively. An additional 3rd vaccination in 16 patients with Tx
[Seroconversion in response to a reinforced primary hepatitis B vaccination in children with cancer]. [2016]Immune response against vaccine antigens may be impaired in children with cancer. The aim of this study was to evaluate the seroconversion response against hepatitis B vaccination (HBV) at the time of chemotherapy onset and/or remission in children with cancer.
Absolute lymphocyte count predicts the response to new influenza virus H1N1 vaccination in pediatric cancer patients. [2021]We measured the vaccination response to the new H1N1 virus in relation to the lymphocyte count prior to vaccination in pediatric cancer patients. The absolute lymphocyte count above the lower normal limits (LNL) for age prior to vaccination predicts the response to influenza vaccination in pediatric cancer patients treated with chemotherapy.
Vaccinations in children with cancer. [2010]Children with cancer may be immunocompromised as a result of their primary underlying disease and/or the use of prolonged and intensive chemotherapy administered with or without irradiation. The damage to the immune system varies with the age of the patient, the type of cancer, and the intensity of the chemotherapy used to treat it. This review analyses the data regarding the immunogenicity, efficacy, safety and tolerability of the vaccines usually recommended in the first years of life in order to help pediatricians choose the best immunisation programme against vaccine-preventable disease in children with cancer receiving standard-dose chemotherapy. Areas for future research are highlighted because new data are required to be able to draw up evidence-based recommendations that will ensure adequate protection against infectious diseases in such high-risk children.
Humoral immune response after post-chemotherapy booster diphtheria-tetanus-pertussis vaccine in pediatric oncology patients. [2008]The role of post-chemotherapy booster vaccination in pediatric oncology children remains to be established. In this randomized controlled study, we studied the effect of immune responses to diphtheria-tetanus-pertussis (DTP) booster vaccination in children 6 months after completing chemotherapy.
Active immunization of children with leukemia and other malignancies. [2019]Active immunization against measles, Haemophilus influenza B, tetanus, diphtheria, hepatitis B, influenza, poliomyelitis, and, when indicated varicella and pneumococcus induces long-lasting immunologic protection in most healthy pediatric vaccine recipients. Among children receiving immunosuppressive therapy for cancer, possible early loss of specific immunity acquired from prior vaccination or disease, and likely diminished responsiveness to initial or booster vaccination must be considered. In addition, the safety of vaccine administration requires separate study in this population. Published evidence demonstrates preservation of vaccine-induced antibody titers against tetanus, diphtheria, poliomyelitis and (in children treated for lymphoma) pneumococcus. In contrast, prior immunity to varicella, influenza, and hepatitis B (when naturally acquired), and measles (acquired by vaccination) is compromised during and/or after antineoplastic therapy. Studies of immunologic protection acquired by prior vaccination against hepatitis B, varicella, and H influenza have not been published. The safety of administering toxoids and inactivated vaccines in this population is well documented. In contrast, morbidity must be expected if live attenuated vaccines (oral polio vaccine, attenuated measles vaccine or attenuated varicella vaccine) are administered to children receiving anti-cancer therapy. The risks of using live vaccines should be measured against demonstrable benefits in any vaccine program. The response to initial or booster immunizations against tetanus and diphtheria are similar to those in healthy children. For all other immunizations reviewed, responsiveness is diminished during periods of chemotherapy, more strikingly in children treated for leukemia than for solid tumors. Antibody responses to these vaccines range from slightly blunted (in the case of H influenza B) to marginal (influenza) or completely useless (pneumococcus and hepatitis B in children treated for leukemia).
Loss of antibodies and response to (re-)vaccination in children after treatment for acute lymphocytic leukemia: a systematic review. [2018]Intensified chemotherapy regimens resulting in improved survival of children with acute lymphocytic leukemia (ALL) lead to concerns about therapy-induced immune damage reflected by the loss of protection of previous immunizations and the efficacy of (re-)vaccination. The severity of secondary immunodeficiency, however, is not clear and knowledge is based on a limited number of studies. We performed a systematic review on literature concerning vaccination data of children with ALL published since 1980. Eight studies fulfilled the inclusion criteria. Regarding antibody titers after treatment, the number of children who had preserved the defined protection level for antibodies differed widely, ranging from 17 to 98% for diphtheria, 27 to 82% for Bordetella pertussis, 20 to 98% for tetanus, 62 to 100% for poliomyelitis, 35 to 100% for Haemophilus influenzae type B (HiB), 29 to 92% for mumps, 29 to 60% for measles and 72 to 92% for rubella. Most patients however responded to revaccination, demonstrating immunological recovery. Although the designs and results of the included studies varied widely, it can be concluded that cytostatic therapy for ALL in children results in a temporarily reduction of specific antibody levels. Memory is preserved but revaccination may be warranted. This is the first systematic review and the best possible current approximation of chemotherapy-induced immune damage in children after ALL treatment.
SARS-CoV-2 vaccination response in pediatric oncology patients. [2023]There remains limited knowledge about the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in pediatric oncology patients, which is essential to provide counseling and risk adaptation in this vulnerable population. The goal of this study was to understand immunogenicity after vaccination in pediatric oncology patients, and determine if certain clinical factors impacted response.