Clinical Trial of Efficacy and Safety of Sinovac's Adsorbed COVID-19 (Inactivated) Vaccine in Healthcare Professionals

NCT04456595 | Completed Phase 3 DMC

• 1 other identifier: COV-02-IB
• Study Type: interventional
• Target: 12,688
• Locations: 1 country
• Sites: 16

Brief Summary

This is a phase III clinical trial to assess efficacy and safety of the Adsorbed COVID-19 (inactivated) vaccine manufactured by Sinovac in health care professionals

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Incidence of COVID-19 cases after two-doses immunization schedule

  Number of virologically-confirmed symptomatic COVID-19 two weeks after second dose of vaccine

  Two weeks after second dose up to one year after first dose

• Frequency of adverse events up to seven days after immunization

  Frequency of adverse reaction in the seven days following each immunization per age group

  Seven days after each immunization

Secondary Outcomes (10)

• Incidence of COVID-19 cases after two-doses immunization schedule according to previous exposure

  Two weeks after first dose up to one year after first dose

• Incidence of COVID-19 cases after 14-days of first immunization

  Two weeks after last dose uup to one year after first dose

• Combined incidence of SARS-CoV-2 infection

  Two weeks after second dose up to one year after first dose

• Incidence of severe COVID-19 cases after two-doses immunization schedule

  Two weeks after second dose up to one year after first dose

• Frequency of adverse events up to 28 days after immunization

  28 days after each immunization

Study Arms (4)

Adult - Vaccine

EXPERIMENTAL

Participants aging 18-59 years receiving two doses with 14-days interval of Adsorbed COVID-19 (inactivated) Vaccine

Biological: Adsorbed COVID-19 (inactivated) Vaccine

Elderly - Vaccine

EXPERIMENTAL

Participants aging 60 years or above receiving two doses with 14-days interval of Adsorbed COVID-19 (inactivated) Vaccine

Biological: Adsorbed COVID-19 (inactivated) Vaccine

Adult - Placebo

PLACEBO COMPARATOR

Participants aging 18-59 years receiving two doses with 14-days interval of placebo

Biological: Placebo

Elderly - Placebo

PLACEBO COMPARATOR

Participants aging 60 years or above receiving two doses with 14-days interval of placebo

Biological: Placebo

Interventions

Adsorbed COVID-19 (inactivated) Vaccine BIOLOGICAL

Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac

Also known as: CoronaVac

Adult - Vaccine; Elderly - Vaccine

Placebo BIOLOGICAL

Placebo of Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac

Adult - Placebo; Elderly - Placebo

Eligibility Criteria

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

You may qualify if:

• Adults 18 years of age or older;
• Healthcare professionals who work in direct contact care of people with possible or confirmed COVID-19 cases;
• Agree with periodic contacts by phone or electronic means, and home visits;
• Show voluntary intention to participate in the study, documented by the informed consent form signed by participant.

You may not qualify if:

• For females: Pregnancy (confirmed by positive beta-hCG test), breastfeeding or intent to engage in sexual relations with reproductive intent without use of birth control methods in the three months following vaccination;
• Evidence of uncontrolled neurological, cardiac, pulmonary, hepatic or renal disease, according to anamnesis or physical examination. Significant changes in treatment or hospitalizations due to worsening of the condition in the last three months are indicators of uncontrolled disease;
• Diseases with impaired immune system including: neoplasms (except basal cell carcinoma), congenital or acquired immunodeficiencies and autoimmune diseases not controlled according to anamnesis or physical examination. Significant changes in treatment or hospitalizations due to worsening of the condition in the last three months are indicators of uncontrolled disease;
• Behavioral, cognitive or psychiatric disease that, in the opinion of the principal investigator or his or her representative physician, affects the participant's ability to understand and cooperate with all study protocol requirements;
• Any alcohol or drug abuse over the 12 months prior to enrollment in the study that has caused medical, professional or family problems, indicated by clinical history;
• History of severe allergic reactions or anaphylaxis to the study vaccine or to components thereof;
• History of asplenia;
• Participation in another clinical trial with an investigational product in the six months prior to enrollment in the study or planned participation in another clinical trial within the two years following enrollment;
• Previous participation in a study to evaluate a COVID-19 vaccine or prior exposure to a COVID-19 vaccine;
• Use of immunosuppressant therapy regimens within the six months prior to enrollment in the study for planned use within the two years following enrollment. Immunosuppressant therapy regimens include: antineoplastic chemotherapy, radiation therapy and immunosuppressants to induce transplant tolerance, among others.
• Use of immunosuppressive doses of corticosteroids within the three months prior to the enrollment in the study and planned use of immunosuppressive doses of corticoids within the three months following enrollment in the study. Immunosuppressive doses of corticosteroids will be considered the equivalent prednisone 20 mg/day for adults, for longer than one week. Continued use of topical or nasal corticosteroids is not considered an immunosuppressant;
• Received blood products (transfusions or immunoglobulins) within the three months prior to enrollment in the study, or planned administration of blood products or immunoglobulins within the two years following enrollment in the study;
• Suspected or confirmed fever within the 72 hours prior to vaccination or axillary temperature greater than 37.8 °C\* on the day of vaccination (enrollment may be postponed until participant has gone 72 hours without fever);
• Possible or confirmed case of COVID-19 on the day of vaccination (vaccination can be postponed until the participant completes 72 hours without symptoms or the diagnosis is ruled out);
• Received live attenuated virus vaccine or inactivated vaccine within the 28 days or 14 days, respectively, prior to enrollment in the study, or immunization planned within the 28 days after enrollment in the study;

Sponsors & Collaborators

• Butantan Institute: lead
• Sinovac Life Sciences Co., Ltd.: collaborator

Study Sites (16)

Universidade de Brasília

Brasília, Federal District, 71691-082, Brazil

Location

Hospital Universitário Maria Aparecida Pedrossian

Campo Grande, Mato Grosso do Sul, 79080-190, Brazil

Location

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30750-140, Brazil

Location

Hospital Universitário Júlio Müller

Cuiabá, Mount, 78048-902, Brazil

Location

Hospital das Clínicas da Universidade Federal do Paraná

Curitiba, Paraná, 80060-900, Brazil

Location

Hospital Escola da Universidade Federal de Pelotas

Pelotas, Rio Grande do Sul, 96020-360, Brazil

Location

Hospital São Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90619-900, Brazil

Location

Hospital de Amor - Fundação Pio XII

Barretos, São Paulo, 14780-070, Brazil

Location

Hospital das Clínicas da UNICAMP

Campinas, São Paulo, 13083-888, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Ribeirão Preto, São Paulo, 14015-069, Brazil

Location

Universidade Municipal de São Caetano do Sul

São Caetano do Sul, São Paulo, 09521-160, Brazil

Location

Faculdade de Medicina de São José do Rio Preto - FAMERP

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Instituto de Infectologia Emílio Ribas

São Paulo, São Paulo, 01246-900, Brazil

Location

Centro de Pesquisas Clínicas do Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05403 000, Brazil

Location

Instituto Israelita de Ensino e Pesquisa Albert Einstein

São Paulo, São Paulo, 05652-900, Brazil

Location

Instituto de Infectologia Evandro Chagas - Fiocruz

Rio de Janeiro, 21710-232, Brazil

Location

Related Publications (2)

• Palacios R, Patino EG, de Oliveira Piorelli R, Conde MTRP, Batista AP, Zeng G, Xin Q, Kallas EG, Flores J, Ockenhouse CF, Gast C. Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Oct 15;21(1):853. doi: 10.1186/s13063-020-04775-4.

  PMID: 33059771 BACKGROUND

• Luan N, Li T, Wang Y, Cao H, Yin X, Lin K, Liu C. Th2-Oriented Immune Serum After SARS-CoV-2 Vaccination Does Not Enhance Infection In Vitro. Front Immunol. 2022 Apr 8;13:882856. doi: 10.3389/fimmu.2022.882856. eCollection 2022.

  PMID: 35464483 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Vaccines; sinovac COVID-19 vaccine

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

• Ricardo Palacios, MD, PhD

  Butantan Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 2, 2020
• Study Start: July 21, 2020
• Primary Completion: December 17, 2020
• Study Completion: February 17, 2022
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

BR (16)