COVID-19 Vaccination for Cancer

Not currently recruiting at 81 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Oncology Group

Must not be taking: SARS-CoV-2 antibodies, Convalescent plasma

Disqualifiers: Radiation therapy only, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how children, adolescents, and young adults with cancer respond to the COVID-19 vaccine. Researchers seek to determine the vaccine's effectiveness after cancer treatments, which can weaken the immune system. Participants will receive the COVID-19 vaccine (specifically the SARS-CoV-2 vaccine COH04S1) and provide blood samples over time to track their immune response. The trial seeks individuals who are undergoing or have recently completed cancer treatments and are either planning to get or have recently received the COVID-19 vaccine. As an unphased trial, this study offers a unique opportunity for participants to contribute to important research on vaccine effectiveness in cancer patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It seems to focus on the timing of the COVID-19 vaccine in relation to cancer treatments, so it's best to discuss your specific medications with the trial team.

What prior data suggests that this COVID-19 vaccine is safe for children, adolescents, and young adults with cancer?

Research shows that COVID-19 vaccines are generally safe for most people. Previous studies found that vaccines like COH04S1 were well-tolerated, causing few serious side effects. Specifically, these studies demonstrated that COH04S1 effectively helped the body produce antibodies (proteins that fight infections) without harmful reactions.

The COVID-19 vaccines in these studies often led to mild side effects, such as soreness at the injection site, tiredness, or a mild fever, which typically resolve on their own in a few days.

The FDA has approved COVID-19 vaccines for use in many people, indicating their safety in numerous cases. For children, adolescents, and young adults with cancer who might have weaker immune systems, the vaccines remain considered safe based on past research. However, discussing any concerns with a doctor is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to understand how children, adolescents, and young adults with cancer respond to the COVID-19 vaccine. Unlike typical vaccine studies that focus on healthy individuals, this trial investigates the immune response in a vulnerable population with compromised immune systems due to cancer and its treatments. By collecting data over two years, including surveys and blood samples, researchers hope to uncover how effective the vaccine is in building immunity in these patients and if additional boosts are needed. This could lead to tailored vaccination strategies that better protect young cancer patients from COVID-19.

What evidence suggests that the COVID-19 vaccine is effective for children, adolescents, and young adults with cancer?

Research has shown that COVID-19 vaccines help the immune system fight the virus. For individuals without health issues, vaccines have significantly reduced the risk of severe illness or hospitalization. However, people with cancer or those undergoing cancer treatment might not respond as strongly to the vaccine due to weaker immune systems. Early research suggests that the timing of the vaccine in relation to cancer treatment and the number of doses received could affect its effectiveness. This trial will observe how these factors influence the vaccine's effectiveness in children, teens, and young adults with cancer. Participants will receive the COVID-19 vaccine per standard of care and will undergo surveys and biospecimen collection.

Who Is on the Research Team?

Emad K Salman

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

Inclusion Criteria

>= 6 months and =< 37 years of age at time of enrollment

Patient plans to receive one of the food and drug administration (FDA) approved/FDA-emergency use authorization (EUA) approved COVID-19 vaccines

Note: for this observational study, the decision to vaccinate is according to local discretion and should be made prior to consideration of enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination and Initial Monitoring

Participants receive COVID-19 vaccine per standard of care and complete a survey at 1 month. Blood samples are collected at 1, 3, and 6 months.

6 months

Multiple visits for blood sample collection

Extended Monitoring

Participants undergo collection of blood samples at 12, 18, and 24 months to assess durability of immune response.

18 months

Visits at 12, 18, and 24 months

Follow-up

Participants are monitored for post-vaccination symptomatic SARS-CoV-2 infections and longer-term impacts of vaccine immune response.

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• COVID-19 Vaccine

How Is the Trial Designed?

Group I: Observational (survey, biospecimen collection) Experimental Treatment 2 Interventions

Patients receive COVID-19 vaccine per standard of care. Patients also complete a survey at 1 month and undergo collection of blood samples at 1, 3, 6, 12, 18, and 24 months. Patients may complete an additional survey at 1 month after each vaccine boost and undergo collection of blood samples before each vaccine boost, 1 month after each vaccine boost, and at the time of COVID-19 infection.

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04639466

NCT04639466 | A Synthetic MVA-based SARS-CoV-2 ... This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previously designated as COH04S1), a synthetic modified vaccinia Ankara ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8906816/

Safety and immunogenicity of a synthetic multiantigen ... COH04S1 was well tolerated and induced spike-specific and nucleocapsid-specific antibody and T-cell responses. Future evaluation of this COVID- ...

3. nature.com nature.com/articles/s41541-023-00640-y

Synthetic multiantigen MVA vaccine COH04S1 and variant- ... We report efficacy of COH04S1 and analogous Omicron BA.1- and Beta-specific vaccines to protect Syrian hamsters from Omicron subvariants.

4. geovax.com geovax.com/investors/press-releases/geovax-next-generation-covid-19-vaccine-demonstrates-potent-antibody-and-cellular-immunity-in-immunocompromised-patients

GeoVax Next-Generation COVID-19 Vaccine ... The Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024) is evaluating the safety and immunogenicity of GEO-CM04S1, compared to ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04977024

SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA ... This phase 2 trial studies the immune response to GEO-CM04S1 (previously designated as COH04S1) compared to standard of care (SOC) mRNA SARS-COV-2 vaccine ...