SARS-CoV-2 Specific Immune Response After COVID-19 Vaccination in Cancer Patients

NCT ID: NCT05313074

Last Updated: 2022-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-23

Study Completion Date

2022-02-25

Brief Summary

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Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response.

Detailed Description

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A total of 311 participants, including 107 patients with solid tumor and 204 healthy volunteers who received 2 doses of CoronaVac were recruited from National Cancer Institute of Thailand between 2020-2021. Blood samples were collected after second dose of CoronaVac for 15 days and the neutralizing antibody (NAb) titers were detected using live-virus neutralization.SARS-CoV-2 antibody positivity was detected in 77 (72%) patients and 199 (97.5%) healthy volunteers. Antibody positivity rate was lowest (67.2%) in patients who received chemotherapy, followed by patients with post-treatment (74.2%) and patients who planned to start treatment (91.7%). Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, heterologous or otherwise, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response.

Conditions

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COVID-19 Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Cancer patients and healthy volunteers will be compared for effectiveness of CoronaVac vaccine in parallel after 2 doses of vaccination for 15 days by neutralizing antibody test
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

All participants, including patients with solid tumor and healthy volunteers will be received 2 doses of CoronaVac at National Cancer Institute of Thailand between 2020-2021. Blood samples will be collected after second dose of Sinovac for 15 days and the neutralizing antibody (NAb) titers will be detected using live-virus neutralization

Study Groups

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Healthy volunteers

Healthcare workers at National Cancer Institute

Group Type PLACEBO_COMPARATOR

CoronaVac vaccine

Intervention Type BIOLOGICAL

An inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech.

Cancer patients

Cancer patients were divided into 3 groups based on treatment status including

1. active cancer on treatment
2. Planned to start treatment
3. Post-treatment (\<6 months)

Group Type ACTIVE_COMPARATOR

CoronaVac vaccine

Intervention Type BIOLOGICAL

An inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech.

Interventions

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CoronaVac vaccine

An inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech.

Intervention Type BIOLOGICAL

Other Intervention Names

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Sinovac

Eligibility Criteria

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Inclusion Criteria

* Male or Female age at least 18 years
* Patients with a diagnosis of solid tumors
* Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure
* Willing and able to comply with the study procedures.
* Willing to receive a Coronavac vaccine (Sinovac).

Exclusion Criteria

* Patients who cannot provide consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role collaborator

National Cancer Institute, Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Thanarath Imsuwansri, MD

Head of Research Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thanarath Imsuwansri, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute of Thailand

Locations

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National Cancer Institute

Ratchathewi, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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013_2021RC_IN695

Identifier Type: -

Identifier Source: org_study_id

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