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

NCT05157178 | Unknown Phase 4 DMC

• 1 other identifier: ASCLIN 004/2021
• Study Type: interventional
• Target: 1,264
• Locations: 1 country
• Sites: 4

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (4)

• Seroconversion of IgG Anti-S antibodies after two doses of Covid-19 (recombinante) vaccination

  6 months

• Seroconversion of IgG Anti-S antibodies after two doses of Covid-19 (recombinante) by serologic status before vaccination

  6 months

• Geometric mean titer of Anti-S IgG antibodies 6 and 12 months after Covid-19 (recombinante) vaccination

  15 months

• Reactogenicity and Safety of Covid-19 (recombinante) vaccine

  15 months

Study Arms (3)

4 week interval

EXPERIMENTAL

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

Biological: Covid-19 (recombinante) vaccine

8 week interval

EXPERIMENTAL

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

Biological: Covid-19 (recombinante) vaccine

12 week interval

ACTIVE COMPARATOR

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

Biological: Covid-19 (recombinante) vaccine

Interventions

Covid-19 (recombinante) vaccine BIOLOGICAL

Administration of the Covid-19 (recombinante) vaccine

12 week interval; 4 week interval; 8 week interval

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or puerperium
• 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.

Sponsors & Collaborators

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

Study Sites (4)

Instituto de Tecnologia do Paraná (TECPAR)

Curitiba, Paraná, 81.050-000, Brazil

Location

Hospital Universitário Pedro Ernesto/ UERJ

Rio de Janeiro, 20.551-030, Brazil

Location

Policlinica Lincoln de Freitas Filho

Rio de Janeiro, Brazil

Location

Unidade de Ensaios Clínicos em Imunobiológicos

Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

COVID-19

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Clarice Monteiro Vianna

  Bio-Manguinhos/Fiocruz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Only the laboratory technician is blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 14, 2021
• Study Start: July 20, 2021
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

BR (4)