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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Biological: Covid -19 (recombinante) 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). 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.

• Study Type: Interventional
• Enrollment (Anticipated): 662
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Robson Leite de Souza Cruz; Phone Number: 3689 (21) 3882-7000; Email: robson.cruz@bio.fiocruz.br

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 21040-900
    • Recruiting
    • Unidade de Ensaios Clínicos em Imunobiológicos
    • Contact: Maria Vitoria Hadland Seidl, MD; Phone Number: (21)99711-1070; Email: maria.seidl@bio.fiocruz.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 8 week interval; 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.	Biological: Covid -19 (recombinante) vaccine; Third dose of the Covid-19 (recombinante) vaccine, 6 months after the second dose of a two dose Covid-19 (recombinante) homologous vaccine schedule.
Active Comparator: 12 week interval; 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.	Biological: Covid -19 (recombinante) vaccine; Third dose of the Covid-19 (recombinante) vaccine, 6 months after the second dose of a two dose Covid-19 (recombinante) homologous vaccine schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 months
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.	15 months
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.	28 days
IgG Anti-S response after a third dose of Covid-19 (recombinante) vaccine by age groups	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. Compare results between participants with 40 years or less, 40 to 60 years, or more than 60 years.	1 month
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.	15 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Anticipated): March 30, 2022
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): December 2, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ASCLIN 009/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No