> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-immunogenicity-of-booster-sars-cov-2-vaccine-vero-520b7370-e288-4c76-b206-ec48560fe2a5 > Record changed: 2026-10-13 # Safety & Immunogenicity of Booster SARS-CoV-2 Vaccine (Vero Cell) NCT05172193 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) Participants 600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) Lead sponsor PT. Kimia Farma (Persero) Tbk Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) Start date 2021-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) Number of sites 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) ## Title and summary **Summary** The 2019 Coronavirus disease outbreak (COVID-19) was first reported at the end of 2019 in Wuhan China as a severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) infection. In less than a year, SARS-CoV-2 infection has become a pandemic and spread to almost all countries in the world, including Indonesia. World Health Organization data states that there are 4,240,479 confirmed cases of SARS-CoV-2 in Indonesia until 25 October 2021 with a death rate of 143,235 (WHO, 2021a). The Indonesian National Agency of Drug and Food Control (NA-DFC) has issued an Emergency Use Authorization for several SARS-COV-2 Vaccines, including the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm (BPOM, 2021). Clinical data that the actual immune responses decrease after several months are continuously being reported (Marmot et al., 2021), and the decrease of vaccine efficacy due to the appearance of variants is also known (Abu-Raddad et al., 2021; Lopez Bernal et al., 2021). These potential risks suggest the need for a booster dose or periodic booster doses of the SARS-COV-2 Vaccine. In fact, there is a study result given several months after vaccination, which leads to the generation of a higher immune responses (Pan H et al., 2021). Booster dose of SARS-COV-2 Vaccine will either induce a high level of antibody responses against original strain, or enhance the broadly formed T cell immunity regardless of mutant strain to improve individual protection. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Short title** Safety & Immunogenicity of Booster SARS-CoV-2 Vaccine (Vero Cell) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Official title** A Phase II Non-Randomized Open Labelled Clinical Trial to Evaluate the Safety & Immunogenicity of SARS-COV-2 Vaccine (Vero Cell) Inactivated as A Booster Dose Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) ## Dates **Completion date** 2023-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **First posted** 2021-12-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Registry last updated** 2022-09-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Primary completion date** 2023-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Start date** 2021-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) ## Size and sites **Participants** 600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Planned participants** 600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Number of sites** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Lead sponsor** PT. Kimia Farma (Persero) Tbk Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) ## Identifiers **Registry ID** NCT05172193 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **ClinicalTrials.gov ID** NCT05172193 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) ## Outcomes ### Primary outcomes 1. The geometric mean titer (GMT) of anti-SARS-CoV-2 neutralizing antibody at 14 and 28 days Timeframe: Within 28 days after one booster dose To evaluate the immunogenicity at 14 and 28 days after one booster dose of 0.5 mL intramuscular (IM) injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months 2. The geometric mean fold rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody at 14 and 28 days Timeframe: Within 28 days after one booster dose To evaluate the immunogenicity at 14 and 28 days after one booster dose of 0.5 mL intramuscular (IM) injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months 3. The geometric mean titer (GMT) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 14 and 28 days Timeframe: Within 28 days after one booster dose To evaluate the immunogenicity at 14 and 28 days after one booster dose of 0.5 mL intramuscular (IM) injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months 4. The geometric mean fold rise (GMFR) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 14 and 28 days Timeframe: Within 28 days after one booster dose To evaluate the immunogenicity at 14 and 28 days after one booster dose of 0.5 mL intramuscular (IM) injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months ### Secondary outcomes 1. The geometric mean titer (GMT) of anti-SARS-CoV-2 neutralizing antibody at 90, 180, and 360 days Timeframe: At 90, 180, and 360 days after one booster To evaluate the immunogenicity at 90, 180, and 360 days after one booster dose 0.5 mL IM injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months 2. The geometric mean fold rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody at 90, 180, and 360 days Timeframe: At 90, 180, and 360 days after one booster To evaluate the immunogenicity at 90, 180, and 360 days after one booster dose 0.5 mL IM injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months 3. The geometric mean titer (GMT) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 90, 180, and 360 days Timeframe: At 90, 180, and 360 days after one booster To evaluate the immunogenicity at 90, 180, and 360 days after one booster dose 0.5 mL IM injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months 4. The geometric mean fold rise (GMFR) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 90, 180, and 360 days Timeframe: At 90, 180, and 360 days after one booster To evaluate the immunogenicity at 90, 180, and 360 days after one booster dose 0.5 mL IM injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months 5. To proportion of solicited adverse events within 7 days after one booster dose Timeframe: Within 7 days after one booster To evaluate the safety profile of one booster dose 0.5 mL IM injection of SARSCOV-2 Vaccine (Vero Cell) Inactivated in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months 6. To proportion of unsolicited adverse events within 28 days after one booster dose Timeframe: Within 28 days after one booster To evaluate the safety profile of one booster dose 0.5 mL IM injection of SARSCOV-2 Vaccine (Vero Cell) Inactivated in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months 7. To proportion of clinically significant abnormal liver function (AST, ALT, Total Bilirubin) at 14 days and 28 days Timeframe: Within 28 days after one booster To evaluate the safety profile of one booster dose 0.5 mL IM injection of SARSCOV-2 Vaccine (Vero Cell) Inactivated in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months 8. To proportion of serious adverse events within 180 days after one booster dose Timeframe: Within 180 days after one booster To evaluate the safety profile of one booster dose 0.5 mL IM injection of SARSCOV-2 Vaccine (Vero Cell) Inactivated in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes ### 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 Cominarty/Pfizer mRNA COVID-19 Vaccine) authorized for emergency use, 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 PCR-confirmed SARS-CoV-2 infection in the last 90 days prior to dosing. 4. Female 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: 1. Hospitalization for the condition, including day surgical interventions 2. New significant organ function deterioration 3. 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 plans 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. - Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) ## Sites - Universitas Udayana HospitalBadung, IndonesiaCompleted - Bali Mandara HospitalDenpasar, IndonesiaCompleted - Kimia Farma Soetomo Clinic and LaboratoriumSemarang, IndonesiaRecruiting - JIH HospitalSleman, IndonesiaCompleted - Kimia Farma Adisucipto Clinic and LaboratoriumYogyakarta, IndonesiaCompleted - Kimia Farma Diponegoro Clinic and LaboratoriumBandung, IndonesiaRecruiting - Kimia Farma Radio Dalam Clinic and LaboratoriumJakarta, IndonesiaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05172193) ## Related records ### Drugs (1) - [Adintrevimab](https://trialight.com/data/asset/adintrevimab-54fe54a2-887b-412b-94e4-d15b7c142b42.md) ### Lead sponsors (1) - [PT. Kimia Farma (Persero) Tbk](https://trialight.com/data/company/pt-kimia-farma-persero-tbk-832d1490-dfd4-4f4e-843e-830c6e54b7e7.md) ### Conditions (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. Registries lag, and so can we. - Trialight puts clinical, regulatory, genetic and commercial data for biotech and pharma in one place, with every value linked to its source. 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