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

NCT05119738 | Unknown

• 1 other identifier: 210410004
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sars-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

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

  8 to12 weeks after third dose BNT162b2.

Secondary Outcomes (1)

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

  8 to12 weeks after third dose BNT162b2.

Study Arms (2)

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

Three doses of BNT162b2 (observational) BIOLOGICAL

BNT162b2 (COVID 19 mRNA vaccine)

Three doses of BNT162b2.

Two doses of Coronavac and one dose BNT162b2 (observational) BIOLOGICAL

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

Two doses of Coronavac and one of BNT162b2.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Red de Salud UC Christus

Santiago, Chile

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine; sinovac COVID-19 vaccine

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

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Central Study Contacts

Bruno Nervi

CONTACT

9978073559; bnervi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 15, 2021
• Study Start: October 27, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 2, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)