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OpenTrials
Completed

NCT Number: NCT04936997

Immune Response to the COVID-19 Vaccine

Explore the effects on immune response to include a potential third vaccine for the cancer cohort.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Arizona

Tucson, Arizona, 85719, United States

About this study

In recent work performed by the University of Arizona Cancer Center team, 59 patients with a known diagnosis of a solid tumor malignancy on active immunosuppressive cancer therapy were enrolled through the University of Arizona Cancer Center during their routine care. These subjects had a decreased response with the vaccine when compared to the health cohort. The investigators are amending this study to explore the effects on immune response to include a potential third vaccine for the cancer cohort. This will increase the visits required to approximately two more visits. It will require two additional blood samples, one 48 hours prior to third vaccine and the second, 5-11 days after the third vaccine. The following protocol will be for the subjects that decide to continue onto a third vaccination.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must have active solid tumor malignancy diagnosis
  • On active chemotherapy
  • Received two prior SARS-COV2 Pfizer vaccines
  • Age ≥ 18 years
  • Ability to understand and the willingness to sign a written informed consent
  • Agree to comply with study procedures
  • Subjects previously enrolled under the main study

Exclusion criteria

  • History of HIV or organ/bone marrow transplant
  • Actively receiving immunotherapy
  • On active, chronic immunosuppression (>10 mg daily dose of prednisone equivalent)
  • Currently incarcerated or residence of another state
  • Speaks a language other than English.

Treatment and study plan

SARS-COV2 Pfizer Vaccine

Biological

Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Primary outcomes

  1. Immune response

    Time frame: 3 months

    Evaluating immune response to a second COVID-19 vaccination booster (3rd vaccine) in patients with solid tumor malignancies on immunosuppressive cancer therapies by antibody quantification in blood samples.

Secondary outcomes

  1. Adverse events

    Time frame: 3 months

    Evaluating immune response to a second COVID-19 vaccination booster (3rd vaccine) in patients with solid tumor malignancies on immunosuppressive cancer therapies by T-cell quantification in blood samples.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jun 23, 2021
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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