Back to results

Study of Immunogenicity Equivalence of a Homologous Third Dose of Covid-19 (Recombinante) Vaccine

Primary Purpose

COVID-19

Status

Recruiting

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Covid -19 (recombinante) vaccine

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

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

Inclusion Criteria:

Employee of Fundação Oswaldo Cruz, stationed in Manguinhos campus, in Rio de Janeiro.
Previous two-dose vaccine schedule with Covid-19 (recombinante) in both doses, with an interval of8 or 12 weeks between doses.
A 6-month interval (5 to 7 month window) between the second and the third dose of Covid-19 (recombinante) vaccine.
Availability to participate during the entire study, and ability to follow study protocol strictly.
Consent to supply personal contact information, such as telephone numbers, address and other information so the research team may contact the participant (For example, in case the participant fails to attend a scheduled visit without previous notice)
Ability to understand and sign the volunteered and informed consent form, and ability to fill in the adverse events journal at home, according to the evaluation of the principal investigator ou delegated research team members.
Understanding the impossibility of participating in another clinical trial while participating in this clinical trial.

Exclusion Criteria:

Receiving another Covid-19 vaccine after inclusion in the study
Receiving any vaccine 28 days after administration of a third dose of Covid-19 (recombinante) vaccine.
Refusal to sign the voluntary and informed consent form or refusal to permit collection of blood samples before the third dose of the Covid-19 (recombinante) vaccine.
Receiving any other vaccine 28 days before the inclusion in the study
Previous vaccine schedule with other Covid-19 vaccines, in the first and/or second dose.
Covid-19 disease confirmed by RT-PCR (Real time polymerase chain reaction) up to 28 days before inclusion in the study.
Covid-19 symptoms up to 10 days before the inclusion in the study.
Fever (Axillary temperature above 37,8 º C / 100,04 °F) 72 hours before vaccination in the study.
Contraindications to the Covid-19 (recombinante) vaccine - Fiocruz/AstraZeneca
Use of immunosuppressive medication, such as systemic corticosteroids or chemotherapy, or immunosuppressive diseases. We will consider as immunosuppressive doses of systemic corticosteroids daily doses of prednisone of 10mg or more, for more than 14 days.
Incapacitating mental illness
Any discoveries made by the principal investigator that would enhance the risk of an adverse result following the participation in the study, or that in some other way justifies exclusion from the study.

Sites / Locations

Unidade de Ensaios Clínicos em ImunobiológicosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

8 week interval

12 week interval

Arm Description

Third dose Covid-19 (recombinante) vaccine 6 months after the second dose of a two dose vaccine schedule with a 8 week interval between the first two doses.

Third dose Covid-19 (recombinante) vaccine 6 months after the second dose of a two dose vaccine schedule with a 12 week interval between the first two doses.

Outcomes

Primary Outcome Measures

IgG Anti-S response after a third dose of Covid-19 (recombinante) vaccine

Equivalence of antibody IgG Anti-S response in geometric mean titers, measured immediately before and 28 days after a third dose of Covid-19 (recombinante) vaccine, administered 6 months after the second dose of a two-dose homologous Covid-19 (recombinante) vaccine schedule, between participants with an 8 and 12 week interval between the first two doses.

Secondary Outcome Measures

Duration of Immunogenicity after the third dose of Covid-19 (recombinate) vaccine after 3, 6 and 12 months

Antibody IgG Anti-S collected immediately before, 28 days, 3 months, 6 months and 12 months after the third dose of Covid-19 (recombinante) vaccine.

Safety and reactogenicity of a third dose of Covid-19 (recombinate) vaccine

Safety and reactogenicity after a third dose of Covid-19 (recombinate) vaccine, 7 days for solicited adverse events, 28 days for non-solicited adverse events and 12 months for serious adverse events.

Neutralizing antibodies in plaque reduction neutralization test (PRNT) in a smaller sample

Measure neutralizing antibodies in plaque reduction neutralization test (PRNT) in a smaller sample of participants, immediately before and 28 days after the third dose.

IgG Anti-S response after a third dose of Covid-19 (recombinante) vaccine by age groups

Duration of Immunogenicity after the third dose of Covid-19 (recombinate) vaccine after 3, 6 and 12 months by age groups

Antibody IgG Anti-S collected immediately before, 28 days, 3 months, 6 months and 12 months after the third dose of Covid-19 (recombinante) vaccine. Compare results between participants with 40 years or less, 40 to 60 years, or more than 60 years.

Full Information

NCT ID

NCT05142488

First Posted

November 30, 2021

Last Updated

December 1, 2021

Sponsor

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

1. Study Identification

Unique Protocol Identification Number

NCT05142488

Brief Title

Study of Immunogenicity Equivalence of a Homologous Third Dose of Covid-19 (Recombinante) Vaccine

Official Title

Study of Immunogenicity Equivalence After a Homologous Third Dose of Covid-19 (Recombinante) Vaccine, 6 Months After the Second Dose, Comparing Intervals of 8 and 12 Weeks Between the First Two Doses.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 9, 2021 (Actual)

Primary Completion Date

March 30, 2022 (Anticipated)

Study Completion Date

March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the antibody response, safety and reactogenicity of a third dose Covid-19 (recombinante) vaccine, 6 months after a two-dose vaccine schedule using the same vaccine in all doses.

Detailed Description

After being informed about the study and potential risks, all participants giving written informed consent will be evaluated for eligibility criteria. At day 0, participants who meet the eligibility requirements will undergo a thorough medical evaluation and a urine pregnancy test (if applicable). Previous vaccination information will be collected with the participant and checked via digital Covid-19 vaccine certification from the Brazilian public health national immunization program system (SI-PNI) ou from Fundação Oswaldo Cruz (Fiocruz) institutional occupational medicine data. According to the data collected, participants will be placed in one of two groups: 8 or 12 weeks interval between the first two vaccine doses in the vaccine schedule. Eligible and consenting participants will have a blood sample collected and receive immediately after a third dose of the Covid-19 (recombinante) vaccine. Participants will be instructed to fill out an adverse events journal for solicited adverse events for 7 days and non-solicited adverse events for 28 days after the third dose. The research team will contact the participant remotely at least once during the first two weeks. The participant will return for a follow-up visit to the research center 28 days after the third dose, to evaluate adverse events, collect a second blood sample and undergo a thorough medical evaluation. The participant will return to the research center to collect blood samples in three more follow-up visits: 3 months, 6 months and 12 months after the third dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

Only the laboratory technician will be blinded

Allocation

Non-Randomized

Enrollment

662 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

8 week interval

Arm Type

Experimental

Arm Description

Third dose Covid-19 (recombinante) vaccine 6 months after the second dose of a two dose vaccine schedule with a 8 week interval between the first two doses.

Arm Title

12 week interval

Arm Type

Active Comparator

Arm Description

Third dose Covid-19 (recombinante) vaccine 6 months after the second dose of a two dose vaccine schedule with a 12 week interval between the first two doses.

Intervention Type

Biological

Intervention Name(s)

Covid -19 (recombinante) vaccine

Intervention Description

Third dose of the Covid-19 (recombinante) vaccine, 6 months after the second dose of a two dose Covid-19 (recombinante) homologous vaccine schedule.

Primary Outcome Measure Information:

Title

IgG Anti-S response after a third dose of Covid-19 (recombinante) vaccine

Description

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Duration of Immunogenicity after the third dose of Covid-19 (recombinate) vaccine after 3, 6 and 12 months

Description

Antibody IgG Anti-S collected immediately before, 28 days, 3 months, 6 months and 12 months after the third dose of Covid-19 (recombinante) vaccine.

Time Frame

15 months

Title

Safety and reactogenicity of a third dose of Covid-19 (recombinate) vaccine

Description

Safety and reactogenicity after a third dose of Covid-19 (recombinate) vaccine, 7 days for solicited adverse events, 28 days for non-solicited adverse events and 12 months for serious adverse events.

Time Frame

15 months

Title

Neutralizing antibodies in plaque reduction neutralization test (PRNT) in a smaller sample

Description

Measure neutralizing antibodies in plaque reduction neutralization test (PRNT) in a smaller sample of participants, immediately before and 28 days after the third dose.

Time Frame

28 days

Title

IgG Anti-S response after a third dose of Covid-19 (recombinante) vaccine by age groups

Description

Time Frame

1 month

Title

Duration of Immunogenicity after the third dose of Covid-19 (recombinate) vaccine after 3, 6 and 12 months by age groups

Description

Time Frame

15 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Employee of Fundação Oswaldo Cruz, stationed in Manguinhos campus, in Rio de Janeiro. Previous two-dose vaccine schedule with Covid-19 (recombinante) in both doses, with an interval of8 or 12 weeks between doses. A 6-month interval (5 to 7 month window) between the second and the third dose of Covid-19 (recombinante) vaccine. Availability to participate during the entire study, and ability to follow study protocol strictly. Consent to supply personal contact information, such as telephone numbers, address and other information so the research team may contact the participant (For example, in case the participant fails to attend a scheduled visit without previous notice) Ability to understand and sign the volunteered and informed consent form, and ability to fill in the adverse events journal at home, according to the evaluation of the principal investigator ou delegated research team members. Understanding the impossibility of participating in another clinical trial while participating in this clinical trial. Exclusion Criteria: Receiving another Covid-19 vaccine after inclusion in the study Receiving any vaccine 28 days after administration of a third dose of Covid-19 (recombinante) vaccine. Refusal to sign the voluntary and informed consent form or refusal to permit collection of blood samples before the third dose of the Covid-19 (recombinante) vaccine. Receiving any other vaccine 28 days before the inclusion in the study Previous vaccine schedule with other Covid-19 vaccines, in the first and/or second dose. Covid-19 disease confirmed by RT-PCR (Real time polymerase chain reaction) up to 28 days before inclusion in the study. Covid-19 symptoms up to 10 days before the inclusion in the study. Fever (Axillary temperature above 37,8 º C / 100,04 °F) 72 hours before vaccination in the study. Contraindications to the Covid-19 (recombinante) vaccine - Fiocruz/AstraZeneca Use of immunosuppressive medication, such as systemic corticosteroids or chemotherapy, or immunosuppressive diseases. We will consider as immunosuppressive doses of systemic corticosteroids daily doses of prednisone of 10mg or more, for more than 14 days. Incapacitating mental illness Any discoveries made by the principal investigator that would enhance the risk of an adverse result following the participation in the study, or that in some other way justifies exclusion from the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robson Leite de Souza Cruz

Phone

(21) 3882-7000

Ext

3689

robson.cruz@bio.fiocruz.br

Facility Information:

Facility Name

Unidade de Ensaios Clínicos em Imunobiológicos

City

Rio de Janeiro

ZIP/Postal Code

21040-900

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Vitoria Hadland Seidl, MD

Phone

(21)99711-1070

maria.seidl@bio.fiocruz.br

12. IPD Sharing Statement

Learn more about this trial

Study of Immunogenicity Equivalence of a Homologous Third Dose of Covid-19 (Recombinante) Vaccine

We'll reach out to this number within 24 hrs