search
Back to results

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

Primary Purpose

Covid19

Status
Unknown status
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Placebo
Inactivated vaccine booster
mRNA vaccine booster
Viral vector vaccine booster
Sponsored by
Universidad del Desarrollo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring covid-19, inactivated vaccine, booster, Chile

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ELEAMs (Nursing Homes)
  • Hospital de Urgencia Asistencia Publica

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Inactivated vaccine booster

mRNA vaccine booster

Viral vector vaccine booster

Placebo

Arm Description

One standard IM CoronaVac dose (0.5 mL)

One standard IM BNT162b2 dose (0.3 mL)

One standard IM ChAdOx1 dose (0.5 mL)

Saline solution IM (0.3 mL)

Outcomes

Primary Outcome Measures

Early humoral response
Change in SARS-CoV-2 neutralizing antibody levels
Immunogenicity
Change in SARS-CoV-2 neutralizing antibody levels

Secondary Outcome Measures

Reactogenicity
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/)
Safety of booster dose
Number of subjects presenting serious adverse events post booster dose.

Full Information

First Posted
August 2, 2021
Last Updated
August 4, 2021
Sponsor
Universidad del Desarrollo
Collaborators
Ministry of Health, Chile, University of Chile, Pontificia Universidad Catolica de Chile
search

1. Study Identification

Unique Protocol Identification Number
NCT04992182
Brief Title
Reactogenicity, Safety, and Immunogenicity of Covid-19 Vaccine Booster
Acronym
REFUERZO
Official Title
Reactogenicidad, Seguridad e Inmunogenicidad de Dosis de Refuerzo de Vacunas Contra SARS-CoV-2 en Chile (Estudio REFUERZO)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 8, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad del Desarrollo
Collaborators
Ministry of Health, Chile, University of Chile, Pontificia Universidad Catolica de Chile

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
covid-19, inactivated vaccine, booster, Chile

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
534 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inactivated vaccine booster
Arm Type
Experimental
Arm Description
One standard IM CoronaVac dose (0.5 mL)
Arm Title
mRNA vaccine booster
Arm Type
Experimental
Arm Description
One standard IM BNT162b2 dose (0.3 mL)
Arm Title
Viral vector vaccine booster
Arm Type
Experimental
Arm Description
One standard IM ChAdOx1 dose (0.5 mL)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline solution IM (0.3 mL)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
0.3 mL IM saline solution
Intervention Type
Biological
Intervention Name(s)
Inactivated vaccine booster
Other Intervention Name(s)
CoronaVac
Intervention Description
0.5 mL IM
Intervention Type
Biological
Intervention Name(s)
mRNA vaccine booster
Other Intervention Name(s)
BNT162b2
Intervention Description
0.3 mL IM
Intervention Type
Drug
Intervention Name(s)
Viral vector vaccine booster
Other Intervention Name(s)
ChAdOx1
Intervention Description
0.5 mL IM
Primary Outcome Measure Information:
Title
Early humoral response
Description
Change in SARS-CoV-2 neutralizing antibody levels
Time Frame
Baseline (90-120 days after second dose of CoronaVac) and 15 days post booster dose
Title
Immunogenicity
Description
Change in SARS-CoV-2 neutralizing antibody levels
Time Frame
Baseline, 15, 30, 60, and 90 days post booster dose
Secondary Outcome Measure Information:
Title
Reactogenicity
Description
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/)
Time Frame
days 7, 28, and 3 months post booster dose
Title
Safety of booster dose
Description
Number of subjects presenting serious adverse events post 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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
ELEAMs (Nursing Homes)
City
Santiago
Country
Chile
Facility Name
Hospital de Urgencia Asistencia Publica
City
Santiago
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Owing to data privacy regulations, the individual-level data in this study cannot be shared (Law N19.628).

Learn more about this trial

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

We'll reach out to this number within 24 hrs