Reactogenicity, Safety, and Immunogenicity of Covid-19 Vaccine Booster

Covid19 Clinical Trial

— REFUERZO  

Official title:

Reactogenicidad, Seguridad e Inmunogenicidad de Dosis de Refuerzo de Vacunas Contra SARS-CoV-2 en Chile (Estudio REFUERZO)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04992182
• Other study ID #: 2021-71
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 8, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2021
• Source: Universidad del Desarrollo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Preliminary data suggest that inactivated vaccine-induced neutralizing antibodies against SARS-CoV-2 decrease at six months after vaccination. Observational, unpublished data also indicate that vaccine effectiveness against Covid-19 wanes over time. Thus, the investigators aimed to determine the reactogenicity, safety, and immunogenicity of a homologous or heterologous booster of SARS-CoV-2 vaccines among people already immunized with an inactivated SARS-CoV-2 vaccine. The study focuses on the elderly population and healthcare workers.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 534
• Est. completion date: June 30, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Full immunization with CoronaVac (2 doses; 0,28) prior to April 15, 2021

• Being a resident of any of the eligible Nursing Homes (located in the Metropolitan Region of Chile)

• Healthcare workers of one of the eligible Nursing Homes.

• Healthcare workers of Hospital de Urgencia Asistencia Publica (HUAP, Santiago, Chile)

Exclusion Criteria:

• Prior history of Covid-19

• Not able to consent

Related Conditions & MeSH terms

• Covid19

Intervention

Biological:
• Placebo
0.3 mL IM saline solution
• Inactivated vaccine booster
0.5 mL IM
• mRNA vaccine booster
0.3 mL IM

Drug:
• Viral vector vaccine booster
0.5 mL IM

Locations

Country	Name	City	State
Chile	ELEAMs (Nursing Homes)	Santiago
Chile	Hospital de Urgencia Asistencia Publica	Santiago

Sponsors (4)

Lead Sponsor	Collaborator
Universidad del Desarrollo	Ministry of Health, Chile, Pontificia Universidad Catolica de Chile, University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early humoral response	Change in SARS-CoV-2 neutralizing antibody levels	Baseline (90-120 days after second dose of CoronaVac) and 15 days post booster dose
Primary	Immunogenicity	Change in SARS-CoV-2 neutralizing antibody levels	Baseline, 15, 30, 60, and 90 days post booster dose
Secondary	Reactogenicity	Solicited and unsolicited. Events will be assessed by scheduled visits performed by nursing home´s nurse stuff. Telephone numbers, including the PI´s cell phone will be available 24/7 for reporting any unsolicited reaction. Reporting will follow national regulations available at the Institute of Public Health web page (https://www.ispch.cl/anamed/farmacovigilancia/vacunas/como-notificar-esavi/)	days 7, 28, and 3 months post booster dose
Secondary	Safety of booster dose	Number of subjects presenting serious adverse events post booster dose.	In addition to the scheduled visits mentioned in Outcome 3, Telephone numbers, including the PI´s cell phone will be available 24/7 throughout the study (1 year) for reporting any unsolicited reaction.