Official Title
Reactogenicidad, Seguridad e Inmunogenicidad de Dosis de Refuerzo de Vacunas Contra SARS-CoV-2 en Chile (Estudio REFUERZO)
Brief 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 Observational, unpublished data also indicate that vaccine effectiveness against Covid-19 wanes over time.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.

Active, not recruiting
COVID19

Biological: Placebo

0.3 mL IM saline solution

Biological: Inactivated vaccine booster

0.5 mL IM
Other Name: CoronaVac

Biological: mRNA vaccine booster

0.3 mL IM
Other Name: BNT162b2

Drug: Viral vector vaccine booster

0.5 mL IM
Other Name: ChAdOx1

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Chile
Locations

ELEAMs (Nursing Homes)
Santiago, Chile

Hospital de Urgencia Asistencia Publica
Santiago, Chile

Universidad del Desarrollo
NCT Number
Keywords
Covid-19
inactivated vaccine
Booster
Chile
MeSH Terms
COVID-19
Vaccines