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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

534 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-08

Study Completion Date

2022-06-30

Brief Summary

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 Observational, unpublished data also indicate that vaccine effectiveness against Covid-19 wanes over time.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

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Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Inactivated vaccine booster

One standard IM CoronaVac dose (0.5 mL)

Group Type EXPERIMENTAL

Inactivated vaccine booster

Intervention Type BIOLOGICAL

0.5 mL IM

mRNA vaccine booster

One standard IM BNT162b2 dose (0.3 mL)

Group Type EXPERIMENTAL

mRNA vaccine booster

Intervention Type BIOLOGICAL

0.3 mL IM

Viral vector vaccine booster

One standard IM ChAdOx1 dose (0.5 mL)

Group Type EXPERIMENTAL

Viral vector vaccine booster

Intervention Type DRUG

0.5 mL IM

Placebo

Saline solution IM (0.3 mL)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

0.3 mL IM saline solution

Interventions

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Placebo

0.3 mL IM saline solution

Intervention Type BIOLOGICAL

Inactivated vaccine booster

0.5 mL IM

Intervention Type BIOLOGICAL

mRNA vaccine booster

0.3 mL IM

Intervention Type BIOLOGICAL

Viral vector vaccine booster

0.5 mL IM

Intervention Type DRUG

Other Intervention Names

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CoronaVac BNT162b2 ChAdOx1

Eligibility Criteria

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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)