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Immunogenicity Study of the Covid-19 (Recombinante) Vaccine With a 4 or 8 Week Interval Between the First Doses.

Primary Purpose

COVID-19

Status
Active
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Covid-19 (recombinante) vaccine
Sponsored by
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • 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.
  • Ability to fill out the adverse events journal at home

Exclusion Criteria:

  • Pregnancy or puerperium
  • Having received any other Covid-19 vaccine any time before inclusion in the study
  • Having received any other vaccine 30 days before inclusion in the study
  • Covid-19 disease confirmed by RT-PCR (Real time polymerase chain reaction) up to 28 days before inclusion in the study.
  • Covid-19 symptoms during evaluation of inclusion in the study (Day 0).
  • 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.
  • 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

  • Instituto de Tecnologia do Paraná (TECPAR)
  • Hospital Universitário Pedro Ernesto/ UERJ
  • Policlinica Lincoln de Freitas Filho
  • Unidade de Ensaios Clínicos em Imunobiológicos

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

4 week interval

8 week interval

12 week interval

Arm Description

Administration of two doses of the Covid-19 (recombinante) vaccine, with a 4 week interval between the two doses.

Administration of two doses of the Covid-19 (recombinante) vaccine, with a 8 week interval between the two doses.

Administration of two doses of the Covid-19 (recombinante) vaccine, with a 12 week interval between the two doses.

Outcomes

Primary Outcome Measures

Geometric mean titers of IgG Anti-S antibody after two doses of Covid-19 (recombinante)
Geometric mean titers of IgG Anti-S antibodies, obtained immediately before the first dose and 28 days after the second dose of the Covid-19 (recombinante) vaccine, comparing 4 and 8 week intervals to 12 weeks interval between the first two to doses

Secondary Outcome Measures

Seroconversion of IgG Anti-S antibodies after two doses of Covid-19 (recombinante) vaccination
Seroconversion proportion, defined by an elevation of Anti-S antibody titers four times after two doses of Covid-19 (recombinante), in comparison to baseline (immediately before the first dose), comparing 4 and 8 week intervals to 12 weeks interval between the first two to doses
Seroconversion of IgG Anti-S antibodies after two doses of Covid-19 (recombinante) by serologic status before vaccination
Seroconversion proportion, defined by an elevation of Anti-S antibody titers four times after two doses of Covid-19 (recombinante), in comparison to baseline (immediately before the first dose), comparing 4 and 8 week intervals to 12 weeks interval between the first two to doses and serologic status before vaccination
Geometric mean titer of Anti-S IgG antibodies 6 and 12 months after Covid-19 (recombinante) vaccination
Geometric mean titer of Anti-S IgG antibodies 6 and 12 months after the vaccination, according to vaccination interval group (4, 8 ans 12 weeks) and serologic status before vaccination.
Reactogenicity and Safety of Covid-19 (recombinante) vaccine
Frequency, intensity and causality of solicited and non solicited adverse events up to 28 days after vaccination with Covid-19 (recombinante) vaccine. Frequency and causality of severe adverse events throughout participation in the study.

Full Information

First Posted
December 10, 2021
Last Updated
June 12, 2023
Sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
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1. Study Identification

Unique Protocol Identification Number
NCT05157178
Brief Title
Immunogenicity Study of the Covid-19 (Recombinante) Vaccine With a 4 or 8 Week Interval Between the First Doses.
Official Title
Immunogenicity Study of the Covid-19 (Recombinante) Vaccine - Fiocruz/AstraZeneca When Administered With a 4 or 8 Weeks Interval Between the First Two Doses.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
June 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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this clinical trial is to compare antibody response and safety of the Covid-19 (recombinante) vaccine according to different time intervals between the first two doses (4, 8 and 12 weeks) and serologic status immediately before the vaccine.
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). Eligible participants will be placed in one of three vaccination interval groups (4, 8 or 12 weeks between the first two Covid -19 (recombinante) vaccine doses) in a randomized manner, via a computer program created by the statistical annalist. Both participant and research team will know the allocated group. Eligible and consenting participants will have a blood sample collected (IgG Anti-S antibodies) and immediately after be administered 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 each dose. The research team will contact the participant remotely at least twice during the first two weeks. The participant will return for a follow-up visit to the research center 28 days after each dose, to evaluate adverse events, collect blood samples (IgG Anti-S antibodies) and undergo a thorough medical evaluation. The participant will also return to the research center to collect blood samples (IgG Anti-S antibodies) in two more follow-up visits: 6 and 12 months after vaccination with Covid-19 (recombinante).

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 is blind
Allocation
Randomized
Enrollment
1264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4 week interval
Arm Type
Experimental
Arm Description
Administration of two doses of the Covid-19 (recombinante) vaccine, with a 4 week interval between the two doses.
Arm Title
8 week interval
Arm Type
Experimental
Arm Description
Administration of two doses of the Covid-19 (recombinante) vaccine, with a 8 week interval between the two doses.
Arm Title
12 week interval
Arm Type
Active Comparator
Arm Description
Administration of two doses of the Covid-19 (recombinante) vaccine, with a 12 week interval between the two doses.
Intervention Type
Biological
Intervention Name(s)
Covid-19 (recombinante) vaccine
Intervention Description
Administration of the Covid-19 (recombinante) vaccine
Primary Outcome Measure Information:
Title
Geometric mean titers of IgG Anti-S antibody after two doses of Covid-19 (recombinante)
Description
Geometric mean titers of IgG Anti-S antibodies, obtained immediately before the first dose and 28 days after the second dose of the Covid-19 (recombinante) vaccine, comparing 4 and 8 week intervals to 12 weeks interval between the first two to doses
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Seroconversion of IgG Anti-S antibodies after two doses of Covid-19 (recombinante) vaccination
Description
Seroconversion proportion, defined by an elevation of Anti-S antibody titers four times after two doses of Covid-19 (recombinante), in comparison to baseline (immediately before the first dose), comparing 4 and 8 week intervals to 12 weeks interval between the first two to doses
Time Frame
6 months
Title
Seroconversion of IgG Anti-S antibodies after two doses of Covid-19 (recombinante) by serologic status before vaccination
Description
Seroconversion proportion, defined by an elevation of Anti-S antibody titers four times after two doses of Covid-19 (recombinante), in comparison to baseline (immediately before the first dose), comparing 4 and 8 week intervals to 12 weeks interval between the first two to doses and serologic status before vaccination
Time Frame
6 months
Title
Geometric mean titer of Anti-S IgG antibodies 6 and 12 months after Covid-19 (recombinante) vaccination
Description
Geometric mean titer of Anti-S IgG antibodies 6 and 12 months after the vaccination, according to vaccination interval group (4, 8 ans 12 weeks) and serologic status before vaccination.
Time Frame
15 months
Title
Reactogenicity and Safety of Covid-19 (recombinante) vaccine
Description
Frequency, intensity and causality of solicited and non solicited adverse events up to 28 days after vaccination with Covid-19 (recombinante) vaccine. Frequency and causality of severe adverse events throughout participation in the study.
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Ability to fill out the adverse events journal at home Exclusion Criteria: Pregnancy or puerperium Having received any other Covid-19 vaccine any time before inclusion in the study Having received any other vaccine 30 days before inclusion in the study Covid-19 disease confirmed by RT-PCR (Real time polymerase chain reaction) up to 28 days before inclusion in the study. Covid-19 symptoms during evaluation of inclusion in the study (Day 0). 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clarice Monteiro Vianna
Organizational Affiliation
Bio-Manguinhos/Fiocruz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Tecnologia do Paraná (TECPAR)
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
81.050-000
Country
Brazil
Facility Name
Hospital Universitário Pedro Ernesto/ UERJ
City
Rio De Janeiro
ZIP/Postal Code
20.551-030
Country
Brazil
Facility Name
Policlinica Lincoln de Freitas Filho
City
Rio de Janeiro
Country
Brazil
Facility Name
Unidade de Ensaios Clínicos em Imunobiológicos
City
Rio de Janeiro
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity Study of the Covid-19 (Recombinante) Vaccine With a 4 or 8 Week Interval Between the First Doses.

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