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Status unknownNCT05119738Updated Feb 2, 2022

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

An observational study in Sars-CoV-2 Infection, sponsored by Pontificia Universidad Catolica de Chile. Status unknown at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-02.

Sponsored by Pontificia Universidad Catolica de Chile · Observational

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
122
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Sars-CoV-2 Infection

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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 122 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
122 participants (estimated)
Patient registry
No

Groups and cohorts

  • Three doses of BNT162b2.

    Cancer patients on active cytotoxic treatment who received three doses of BNT162b2.

    Biological: Three doses of BNT162b2 (observational)

  • 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)

Interventions

  • BiologicalThree doses of BNT162b2 (observational)

    BNT162b2 (COVID 19 mRNA vaccine)

  • BiologicalTwo doses of Coronavac and one dose BNT162b2 (observational)

    BNT162b2 (COVID 19 mRNA vaccine) Coronavac (COVID 19 inactive vaccine)

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What researchers measure

Primary outcomes

  1. Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster vaccine).

    Time frame: 8 to12 weeks after third dose BNT162b2.

Secondary outcomes

  1. Neutralizing geometric mean titers 8 to 12 weeks after third dose BNT162b2 (booster vaccine)

    Time frame: 8 to12 weeks after third dose BNT162b2.

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Study locations

1 of 1 sites recruiting
  • Red de Salud UC Christus
    Santiago, Chile
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05119738
Lead sponsor
Pontificia Universidad Catolica de Chile
Responsible party
Sponsor
First posted
Nov 15, 2021
Start date
Oct 27, 2021
Primary completion
Mar 1, 2022 (estimated)
Completion
Jun 1, 2022 (estimated)
Last update
Feb 2, 2022

Study contacts

Bruno Nervi
Contact
bnervi@gmail.com
9978073559

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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