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

• Status: Active, not recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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 Observational, unpublished data also indicate that vaccine effectiveness against Covid-19 wanes over time.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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidad del Desarrollo
• Collaborators: Ministry of Health, Chile; Pontificia Universidad Catolica de Chile; University of Chile
• Treatments: Vaccines

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