COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05172193

Prenali Dwisthi Sattwika

boost.vctrial@gmail.com

2021-12-29

Recruiting

nonRCT

Non-randomized

Single group assignment

Open label

multi-center

Prevention

inclusion criteria: 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.

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. 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) 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. -

1

PT. Kimia Farma (Persero) Tbk

18

100

Indonesia

Healthy volunteers

N/A

600

The geometric mean fold rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody at 14 and 28 days;The geometric mean fold rise (GMFR) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 14 and 28 days;The geometric mean titer (GMT) of anti-SARS-CoV-2 neutralizing antibody at 14 and 28 days;The geometric mean titer (GMT) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 14 and 28 days

None

Phase 2

[{"arm_notes": "0,5mL;IM", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]