Clinical trial NCT04508075: Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine
Official title: A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: SARS-CoV2 Infection
Keywords: vaccine
SARS-CoV-2
infection
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
Collaborators: name: Faculty of Medicine Universitas Padjadjaran
name: National Intitute of Health Research and Development, Ministry of Health Republic of Indonesia
name: Sinovac Life Sciences Co., Ltd.
First posted: 2020-08-11
Enrollment: 1620
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects 18-59 years of age: Randomized, observer blind, placebo-controlled two arms parallel group, prospective intervention study, to evaluate efficacy, safety, immunogenicity SARS-CoV-2 vaccine (inactivated)
Primary purpose: PREVENTION

Brief summary: This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation

Detailed description: This trial is Randomized, observer-blind, placebo-controlled two arms parallel group, prospective intervention study

Approximately 1620 subjects aged 18-59 years will be enrolled in this trial for efficacy evaluation. Subjects will be divided into 2 treatment arms that are the vaccinated group and placebo group with ratio 1:1. The vaccinated arms will be grouped into three different lot number (lot 1/lot 2/ lot 3) of SARS-CoV-2 vaccine.

Eligibility criteria: Inclusion Criteria:

1. Clinically healthy adults aged 18 - 59 years.
2. Subjects have been informed properly regarding the study and signed the informed consent form.
3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
2. Contact with novel coronavirus infected persons (positive for nucleic acid detection) within 14 days prior to the trial.
3. Contact to patients with fever or respiratory symptoms surrounding areas or from communities with reported cases within 14 days prior to the trial.
4. Two or more cases of fever and/or respiratory symptoms in a small area such as home, office, school and class within 14 days prior to the trial.
5. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
6. The result of RT-PCR of swab nasopharyngeal is positive
7. Reactive IgG and IgM for SARS-CoV-2 (by standardize rapid test).
8. Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
9. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
10. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
11. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.
12. Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\> 2 weeks)).
13. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome
14. Subjects receive any vaccination within 1 month before and after IP immunization.
15. Subjects plan to move from the study area before the end of study period.

Primary outcomes:
measure: Incidence of laboratory-confirmed COVID-19 after the second dose
timeFrame: 14 days to 6 months after the second dose
Secondary outcomes:
measure: Incidence of suspected COVID-19 cases
timeFrame: within 14 days to 6 months after the second dose.
measure: Incidence of laboratory-confirmed cases (severe, critical and death)
timeFrame: within 14 days to 6 months after the second dose
measure: Seroconversion rate anti-S antibody IgG titer (ELISA)
timeFrame: 14 days after two doses of vaccination
measure: Seroconversion rate anti-S antibody IgG titer (ELISA)
timeFrame: 6 months after two doses of vaccination
measure: Seropositive rate of neutralizing antibodies
timeFrame: 14 days after two doses of vaccination
measure: Seropositive rate of neutralizing antibodies
timeFrame: 6 months after two doses of vaccination
Other outcomes:
measure: Local reaction and systemic events
timeFrame: 30 minutes to 14 days after each vaccination
measure: Local reaction and systemic events occurring after the last vaccination
timeFrame: 14 days to 28 days following last vaccination
measure: Serious adverse events during study
timeFrame: 6 months after the last dose
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin Hospital/School of Medicine, Padjadjaran University
state: West Java
Study officials:
References: