Reactogenicity, Safety, and Immunogenicity of Covid-19 Vaccine Booster (REFUERZO)

August 4, 2021 updated by: Rafael Araos, Universidad del Desarrollo

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

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 Observational, unpublished data also indicate that vaccine effectiveness against Covid-19 wanes over time.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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

534

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • ELEAMs (Nursing Homes)
      • Santiago, Chile
        • Hospital de Urgencia Asistencia Publica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inactivated vaccine booster
One standard IM CoronaVac dose (0.5 mL)
Biological: Inactivated vaccine booster
0.5 mL IM
Other Names:
  • CoronaVac
Experimental: mRNA vaccine booster
One standard IM BNT162b2 dose (0.3 mL)
Biological: mRNA vaccine booster
0.3 mL IM
Other Names:
  • BNT162b2
Experimental: Viral vector vaccine booster
One standard IM ChAdOx1 dose (0.5 mL)
Drug: Viral vector vaccine booster
0.5 mL IM
Other Names:
  • ChAdOx1
Placebo Comparator: Placebo
Saline solution IM (0.3 mL)
Biological: Placebo
0.3 mL IM saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early humoral response
Time Frame: Baseline (90-120 days after second dose of CoronaVac) and 15 days post booster dose
Change in SARS-CoV-2 neutralizing antibody levels
Baseline (90-120 days after second dose of CoronaVac) and 15 days post booster dose
Immunogenicity
Time Frame: Baseline, 15, 30, 60, and 90 days post booster dose
Change in SARS-CoV-2 neutralizing antibody levels
Baseline, 15, 30, 60, and 90 days post booster dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reactogenicity
Time Frame: days 7, 28, and 3 months post booster dose
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
Safety of booster dose
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad del Desarrollo

Collaborators

Pontificia Universidad Catolica de Chile
University of Chile
Ministry of Health, Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2021

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-71

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Owing to data privacy regulations, the individual-level data in this study cannot be shared (Law N19.628).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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