Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Cancer Patients on Active Treatment

February 1, 2022 updated by: Pontificia Universidad Catolica de Chile

The Coronavirus Disease 2019 (COVID-19) pandemic has claimed over 5 million lives globally. Fortunately, a substantial and growing number of SARS-CoV-2 vaccines with very high efficacy have been developed, manufactured, and rapidly approved. Novel mRNA vaccines such as the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) have reported a stunning >94% efficacy against COVID-19. However, global access has not been equitable, with many low- and middle-income countries having no vaccine access or access under emergency use mainly to traditional inactivated SARS-CoV2-2 vaccines such as BBIBP-CorV (Sinopharm Beijing), CoronaVac (Sinovac) and BBV152 (Bharat Biotech). Emerging studies have shown that lower concentrations of neutralizing antibodies (Nab) are attained after CoronaVac than after a mRNA-based vaccine in healthy individuals. This difference seems to be more pronounced in immunocompromised patients who are at higher risk of severe COVID-19 and death from COVID-19. As such several countries including United States, Israel and Chile have recommended a third vaccine dose for this vulnerable population.

In this observational study we will explore the humoral response to the BNT162b2 vaccine in patients who received two previous doses of the inactivated vaccine Coronavac or two doses of BNT162b2.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Chile
      • Santiago, Chile
        • Recruiting
        • Red de Salud UC Christus
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cancer patients receiving their care at the Red de Salud UC Christus in Santiago Chile will be invited

Description

Inclusion Criteria:

  • Vaccination with two doses of Coronavac vaccine or BNT162b2 vaccine
  • Eastern Cooperative Oncology group performance status < 3

Exclusion Criteria:

  • Previous SARS-CoV-2 infection
  • Vaccination with booster vaccine more than 12 weeks before informed consent
  • Intravenous inmunoglobulin therapy 60 days before informed consent
  • Any condition that could interfere with the paticipant´s participation during the study in the opinion of the treating investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Three doses of BNT162b2.
Cancer patients on active cytotoxic treatment who received three doses of BNT162b2.
Biological: Three doses of BNT162b2 (observational)
BNT162b2 (COVID 19 mRNA vaccine)
Two doses of Coronavac and one of BNT162b2.
Cancer patients on active cytotoxic treatment who received two doses of Coronavac and one dose of BNT162b2.
Biological: Two doses of Coronavac and one dose BNT162b2 (observational)
BNT162b2 (COVID 19 mRNA vaccine) Coronavac (COVID 19 inactive vaccine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster vaccine).
Time Frame: 8 to12 weeks after third dose BNT162b2.
8 to12 weeks after third dose BNT162b2.

Secondary Outcome Measures

Outcome Measure
Time Frame
Neutralizing geometric mean titers 8 to 12 weeks after third dose BNT162b2 (booster vaccine)
Time Frame: 8 to12 weeks after third dose BNT162b2.
8 to12 weeks after third dose BNT162b2.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

November 10, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

February 2, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 210410004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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