A Phase II Non-Randomized Open Label, Clinical Trial to Evaluate the Safety and Immunogenicity of SARS-COV-2 Vaccine (Vero Cell) Inactivated as A Booster Dose Protocol Number: BOOST-VC-0221

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Clinical Epidemiology and Biostatistics Unit(CEBU) Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada (UGM)
No Registry
INA-A3BD6H9
Tanggal Input Registry : 30-04-2024

31-12-2021
a. Baseline Data 1.Data with continuous scale (age, body mass index, vital signs, time interval between the second dose of prime vaccine and booster dose, level of AST, ALT, Total Bilirubin) will be presented in mean and standard deviation (SD).Data with categorical scale (sex, smoking status, occupation, comorbidities, concomitant medications, type of prime vaccine) will be presented in number and proportion. 2.Comparation baseline with continuous scale will be tested with T-test/Mann-Whitney test. 3.Comparation baseline with categorical scale will be tested with Chi-Square test. b. Immunogenicity Data 1.Data with continuous scale (age, body mass index, vital signs, time interval between the second dose of prime vaccine and booster dose, level of AST, ALT, Total Bilirubin) will be presented in mean and standard deviation (SD).Data with categorical scale (sex, smoking status, occupation, comorbidities, concomitant medications, type of prime vaccine) will be presented in number and proportion. 2.Comparation baseline with continuous scale will be tested with T-test/Mann-Whitney test. 3.Comparation baseline with categorical scale will be tested with Chi-Square test. 4.Comparation of anti-sRBD IgG antibody, SARS-CoV-2 SVNT NAb, and SARS-CoV-2 MNT NAb (100 participant subset) between intervention and baseline will be tested with T-test or Mann-Whitney for baseline, 14 days, 28 days, 90 days,180 days for all participants, and 360 days for Sinovac-Sinopharm participants. 5.Immunogenicity analysis will be subgroup analyzed
a. Safety Analysis Data 1.Number of adverse events (serious and non-serious) will be presented in proportions 2.Solicited AE up to 7 days post booster dose will be presented in proportions. 3.Unsolicited AE up to 28 days post booster dose as System Organ Class and Preferred Term will be presented in proportions. 4.Serious Adverse Event (SAE) up to 180 days post booster dose as System Organ Class and Preferred Term will be presented in proportions. 5.Comparation of proportions of Adverse Event Special Interest (AESI) up to 180 days post b. PCR-Confirmed Covid Data Number of PCR-confirmed COVID-19 will be presented in proportion and comparation among intervention will be tested with Chi-Square test, subgroup analyzed based on primary vaccine population.
 
A Phase II Non-Randomized Open Label, Clinical Trial to Evaluate the Safety and Immunogenicity of SARS-COV-2 Vaccine (Vero Cell) Inactivated as A Booster Dose Protocol Number: BOOST-VC-0221
A Phase II Non-Randomized Open Label, Clinical Trial to Evaluate the Safety and Immunogenicity of SARS-COV-2 Vaccine (Vero Cell) Inactivated as A Booster Dose Protocol Number: BOOST-VC-0221
Interventional
Sinopharm Vaccine
600
 

Inclusion Criteria:

1.Adult males or females aged 18 years and above at the time of consent. 2.Participants who provide a voluntarily consent to participate in the study and sign the consent form. 3.Participants who have previously received homologous 2-dose of SARS-COV-2 Vaccine (either Vero Cell inactivated-Sinopharm SARS-COV-2 Vaccine, CoronaVac SARS-COV-2 Vaccine, or AstraZeneca Vaccine) authorized for emergency use, at between 6 to 12 months post second prime vaccine dose prior to Day 1. 4.Participants who have negative results for swab SARS-COV-2 rapid antigen test.

Exclusion Criteria:

1.Participants who are unable to follow clinical and follow-up procedures. 2.Participants with acute fever with temperature above 38℃, coughing, breathing difficulty, chills, muscle ache, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to the dosing. 3.Participants with a history of swab antigen or PCR-confirmed SARS-CoV-2 infection in the last 90 days prior to dosing. 4.Females who are pregnant or breastfeeding. 5.Participants with a history of hypersensitivity or allergic reactions including anaphylaxis. 6.Participants with immune dysfunction, including immunodeficiency disorder, or family history of such conditions, except HIV-positive participants in stable/well-controlled condition. 7.Participants who received chronic administration (defined as more than 14 continuous days) of immunosuppressant medication such as immunomodulator, immune-modifying drug, immunoglobulin, immunotherapy, chemotherapy, systemic corticosteroid, etc. except topical steroids or short-term oral steroids (course lasting ≤ 14 days), or blood-derived products in the last 90 days prior to dosing. 8.Participants with a current clinically significant chronic and unstable cardiovascular, endocrine, gastrointestinal, hepatic (including hepatitis B and C), renal, neurological, respiratory, psychiatric or other medical disorders not excluded by other exclusion criteria, that are assessed by the investigator as being clinically unstable within the prior 90 days as evidenced by: Hospitalization for the condition, including day surgical interventions New significant organ function deterioration Needing addition of new treatments or major dose adjustments of current treatments (mild or moderate well-controlled comorbidities are allowed) 9.Participants with hemophilia or people using anticoagulants who are at a risk of serious bleeding from IM injection. 10.Participants with a current dependent on antipsychotic drugs and narcotic analgesics, or suspected of alcohol or drug dependency. 11.Participants who have received or plan to receive other vaccination(s) within 28 days prior to or during study duration (except for influenza vaccine which is not allowed within 14 days before, or 4 weeks after final dose of IP). 12.Participants who have received or have plans to receive other investigational drug(s) while participating in another clinical study or bioequivalence study within 28 days prior to vaccination
 
Ref: KE/FK/1340/EC/2021
Not applicable
PPUK/PPUB number
dr. Prenali Dwisthi Sattwika, SpPD