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

NCT05142488 | Unknown Phase 4 DMC

• 1 other identifier: ASCLIN 009/2021
• Study Type: interventional
• Target: 662
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  15 months

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

  15 months

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

  28 days

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

  1 month

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

  15 months

Study Arms (2)

8 week interval

EXPERIMENTAL

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

12 week interval

ACTIVE COMPARATOR

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

Interventions

Covid -19 (recombinante) vaccine BIOLOGICAL

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

12 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:

• 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.

You may not qualify if:

• 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.
• Previous vaccine schedule with other Covid-19 vaccines, in the first and/or second dose.
• 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

Sponsors & Collaborators

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

Study Sites (1)

Unidade de Ensaios Clínicos em Imunobiológicos

Rio de Janeiro, 21040-900, Brazil

RECRUITING

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

Central Study Contacts

Robson Leite de Souza Cruz

CONTACT

(21) 3882-7000; robson.cruz@bio.fiocruz.br

Study Design

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

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 2, 2021
• Study Start: November 9, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2023
• Last Updated: December 2, 2021

Record last verified: 2021-12

Locations

BR (1)