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

Sars-CoV-2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05119738
• Other study ID #: 210410004
• Status: Recruiting
• Start date: October 27, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2021
• Source: Pontificia Universidad Catolica de Chile
• Contact: Bruno Nervi
• Phone: 9978073559
• Email: bnervi[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: June 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Sars-CoV-2 Infection

Intervention

Biological:
• Three doses of BNT162b2 (observational)
BNT162b2 (COVID 19 mRNA vaccine)
• Two doses of Coronavac and one dose BNT162b2 (observational)
BNT162b2 (COVID 19 mRNA vaccine) Coronavac (COVID 19 inactive vaccine)

Locations

Country	Name	City	State
Chile	Red de Salud UC Christus	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster vaccine).		8 to12 weeks after third dose BNT162b2.
Secondary	Neutralizing geometric mean titers 8 to 12 weeks after third dose BNT162b2 (booster vaccine)		8 to12 weeks after third dose BNT162b2.