NCT04992182

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 534 (actual)
• Sponsor: Universidad del Desarrollo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 Observational, unpublished data also indicate that vaccine effectiveness against Covid-19 wanes over time.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

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	0.3 mL IM saline solution
BIOLOGICAL	Inactivated vaccine booster	0.5 mL IM
BIOLOGICAL	mRNA vaccine booster	0.3 mL IM
DRUG	Viral vector vaccine booster	0.5 mL IM

Timeline

• Start date: 2021-07-08
• Primary completion: 2021-08-31
• Completion: 2022-06-30
• First posted: 2021-08-05
• Last updated: 2021-08-05

Locations

2 sites across 1 country: Chile

Regulatory

• FDA-regulated drug study