Vaccination Against COVID-19 in Cancer

NCT04715438 | Active Not Recruiting

• 1 other identifier: 202000865
• Study Type: interventional
• Target: 791
• Locations: 1 country
• Sites: 3

Brief Summary

This study will collect information on immune response and adverse events after vaccination against coronavirus disease (COVID-19) in a vulnerable patient cohort. Understanding the ability or disability to mount a protective immune response after vaccination will help to counsel patients during the pandemic and support decisions on whom to vaccinate and to identify patients who require other measures to protect them from COVID-19.

Conditions

Cancer

Keywords

vaccination; COVID-19; solid tumors; immune response

Outcome Measures

Primary Outcomes (1)

• Immune response to vaccination against COVID-19 measured as antibody response expressed as geometric mean concentration: arbitrary units (AU)/ml

  The primary endpoint is the antibody based immune response to vaccination against COVID-19 on day 28 after the second vaccination in patients receiving cancer treatment as compared to individuals without cancer. Expressed as antibody response expressed as geometric mean concentration: arbitrary units (AU)/ml

  Measured at 28 days after vaccination

Secondary Outcomes (5)

• Safety assessment (S)AEs; Incidence and severity of solicited AEs during 7 days after each vaccination with incidence and nature of SAEs reported during 7 days after each vaccination

  During 7 days after vaccination

• Safety assessment immune related (ir), with incidence and nature of newly occurring irAEs grade ≥ 3 in cohort B and D reported up to 28 days

  From start till 28 days after second vaccination

• Safety assessment AE of special interest (SI)s with Incidence, nature and severity of AESIs graded according to CTCAE v5.0 reported up to 12 months after vaccination

  From start till 12 months after vaccination

• Assessment of immune response: expressed as geometric mean antibody concentration: arbitrary units (AU)/ml

  measured at 6 to 18 months after vaccination

• Assessment of immune response: measured as levels of SARS-CoV-2 specific T-cell responses expressed as number of IFNg producing T cells/ million peripheral blood mononuclear cells (PBMCs)

  measured 28 days to 18 months after vaccination

Study Arms (4)

Cohort A: Individuals without cancer

EXPERIMENTAL

A cohort of individuals without a cancer diagnosis is included for comparison. Because age is an important predictor of the ability to mount an effective immune response to vaccination, partners of patients in cohort B, C, and D.

Biological: mRNA-1273 SARS-CoV-2 vaccine from Moderna

Cohort B: patients receiving immunotherapy

EXPERIMENTAL

Cancer patients receiving immunotherapy

Biological: mRNA-1273 SARS-CoV-2 vaccine from Moderna

Cohort C: patients receiving chemotherapy

EXPERIMENTAL

Cancer patients receiving chemotherapy

Biological: mRNA-1273 SARS-CoV-2 vaccine from Moderna

Cohort D: patients receiving chemo-immunotherapy

EXPERIMENTAL

Cancer patients receiving chemo-immunotherapy

Biological: mRNA-1273 SARS-CoV-2 vaccine from Moderna

Interventions

mRNA-1273 SARS-CoV-2 vaccine from Moderna BIOLOGICAL

All participants will receive two vaccinations against COVID-19 according to standard of care.

Cohort A: Individuals without cancer; Cohort B: patients receiving immunotherapy; Cohort C: patients receiving chemotherapy; Cohort D: patients receiving chemo-immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to participate in this study, a subject must meet all of the following criteria:
• Age of 18 years or older
• Life expectancy \> 12 months
• Ability to provide informed consent
• Additional criteria for cohort A:
• Partner of a participating patient
• Additional criteria for cohort B:
• Histological diagnosis of a solid malignancy
• Treatment with monotherapy immune checkpoint inhibitor (ICI) against Programmed Death 1 (PD1) or its ligand PD-L1 (in curative or non-curative setting)
• Last ICI administration within 3 months of vaccination
• Additional criteria for cohort C:
• Histological diagnosis of a solid malignancy
• Treatment with cytotoxic chemotherapy (monotherapy and combination chemotherapy is allowed, as well as a combination with radiotherapy, in curative or non-curative setting)
• Last chemotherapy administration within 4 weeks of vaccination
• Additional criteria for cohort D:

You may not qualify if:

• Confirmed SARS-CoV-2 infection (current or previous)
• Women who are pregnant or breastfeeding
• Active hematologic malignancy
• Any immune deficiency not related to cancer or cancer treatment (e.g. inherited immune deficiency or known infection with Human Immunodeficiency Virus)
• Systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medication within 14 days of vaccination. Inhaled or topical steroids, and adrenal replacement steroids (\> 10 mg daily prednisone equivalent) are permitted. In addition, standard of care with short course steroids to prevent nausea and allergic reactions from chemotherapy or iodinated CT contrast is allowed.
• Additional criteria for cohort A:
• Current or previous diagnosis of a solid malignancy, unless treated with curative intent \>5 years before enrolment and without signs of recurrence during proper follow-up
• Previous history of a hematologic malignancy
• Additional criteria for cohort B:
• Treatment with cytotoxic chemotherapy within 4 weeks of vaccination
• Additional criteria for cohort C:
• Treatment with an ICI within 3 months of vaccination

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (3)

NKI-AvL

Amsterdam, Netherlands

Location

UMCG

Groningen, 9700 RB, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Related Publications (2)

• Piening A, Ebert E, Khojandi N, Alspach E, Teague RM. Immune responses to SARS-CoV-2 in vaccinated patients receiving checkpoint blockade immunotherapy for cancer. Front Immunol. 2022 Dec 13;13:1022732. doi: 10.3389/fimmu.2022.1022732. eCollection 2022.

  PMID: 36582225 DERIVED

• Oosting SF, van der Veldt AAM, GeurtsvanKessel CH, Fehrmann RSN, van Binnendijk RS, Dingemans AC, Smit EF, Hiltermann TJN, den Hartog G, Jalving M, Westphal TT, Bhattacharya A, van der Heiden M, Rimmelzwaan GF, Kvistborg P, Blank CU, Koopmans MPG, Huckriede ALW, van Els CACM, Rots NY, van Baarle D, Haanen JBAG, de Vries EGE. mRNA-1273 COVID-19 vaccination in patients receiving chemotherapy, immunotherapy, or chemoimmunotherapy for solid tumours: a prospective, multicentre, non-inferiority trial. Lancet Oncol. 2021 Dec;22(12):1681-1691. doi: 10.1016/S1470-2045(21)00574-X. Epub 2021 Nov 9.

  PMID: 34767759 DERIVED

MeSH Terms

Conditions

Neoplasms; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• E G de Vries, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 20, 2021
• Study Start: January 8, 2021
• Primary Completion: June 4, 2021
• Study Completion: April 1, 2025
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: we start the make interim results available second half of 2021
• Access Criteria: we aim to share as much as possible also through own website, and COVID-19 platforms that are considered for this kind of research

Locations

NL (3)