Safety & Immunogenicity of Booster SARS-CoV-2 Vaccine (Vero Cell)
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
1 other identifier
interventional
600
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started Dec 2021
Longer than P75 for phase_2 covid19
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2021
CompletedFirst Posted
Study publicly available on registry
December 29, 2021
CompletedStudy Start
First participant enrolled
December 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedSeptember 8, 2022
September 1, 2022
1.7 years
December 23, 2021
September 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
The geometric mean titer (GMT) of anti-SARS-CoV-2 neutralizing antibody at 14 and 28 days
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
Within 28 days after one booster dose
The geometric mean fold rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody at 14 and 28 days
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
Within 28 days after one booster dose
The geometric mean titer (GMT) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 14 and 28 days
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
Within 28 days after one booster dose
The geometric mean fold rise (GMFR) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 14 and 28 days
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
Within 28 days after one booster dose
Secondary Outcomes (8)
The geometric mean titer (GMT) of anti-SARS-CoV-2 neutralizing antibody at 90, 180, and 360 days
At 90, 180, and 360 days after one booster
The geometric mean fold rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody at 90, 180, and 360 days
At 90, 180, and 360 days after one booster
The geometric mean titer (GMT) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 90, 180, and 360 days
At 90, 180, and 360 days after one booster
The geometric mean fold rise (GMFR) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 90, 180, and 360 days
At 90, 180, and 360 days after one booster
To proportion of solicited adverse events within 7 days after one booster dose
Within 7 days after one booster
- +3 more secondary outcomes
Other Outcomes (1)
To proportion of symptomatic PCR-confirmed SARS-CoV-2 infection within 90 and 180 days after one booster dose
Within 180 days after one booster
Study Arms (1)
SARS-COV-2 Vaccine (Vero Cell-Sinopharm) Inactivated
EXPERIMENTALOne booster dose 0.5 mL IM injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated
Interventions
SARS-CoV-2 vaccine (Vero cell) inactivated developed by Beijing Bio-Institute Biological Products Co., Ltd, can induce active immunity and prevent diseases caused by the SARS-CoV-2 virus by producing neutralizing antibody. The inactivated SARSCoV-2 Vaccine (Vero cell) is prepared by inoculating Verda Reno cells (Vero cell) with SARS-CoV-2 HB02 strain, culturing, harvesting, inactivating, clarifying, concentrating, purifying and adding aluminum hydroxide adjuvant.
Eligibility Criteria
You may qualify if:
- Adult males or females aged 18 years and above at the time of consent.
- Participants who provide a voluntarily consent to participate in the study and sign the consent form.
- 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.
- Participants who have negative results for swab SARS-COV-2 rapid antigen test.
You may not qualify if:
- Participants who are unable to follow clinical and follow-up procedures.
- 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.
- Participants with a history of PCR-confirmed SARS-CoV-2 infection in the last 90 days prior to dosing.
- Female who are pregnant or breastfeeding.
- Participants with a history of hypersensitivity or allergic reactions including anaphylaxis.
- Participants with immune dysfunction, including immunodeficiency disorder, or family history of such conditions, except HIV-positive participants in stable/well-controlled condition.
- 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.
- 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)
- Participants with hemophilia or people using anticoagulants who are at a risk of serious bleeding from IM injection.
- Participants with a current dependent on antipsychotic drugs and narcotic analgesics, or suspected of alcohol or drug dependency.
- 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).
- 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Universitas Udayana Hospital
Badung, Bali, Indonesia
Bali Mandara Hospital
Denpasar, Bali, Indonesia
Kimia Farma Soetomo Clinic and Laboratorium
Semarang, Central Java, Indonesia
JIH Hospital
Sleman, D.I. Yogyakarta, Indonesia
Kimia Farma Adisucipto Clinic and Laboratorium
Yogyakarta, D.I. Yogyakarta, Indonesia
Kimia Farma Diponegoro Clinic and Laboratorium
Bandung, West Java, Indonesia
Kimia Farma Radio Dalam Clinic and Laboratorium
Jakarta, Indonesia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 23, 2021
First Posted
December 29, 2021
Study Start
December 31, 2021
Primary Completion
September 30, 2023
Study Completion
September 30, 2023
Last Updated
September 8, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share