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Clinical trial

a Phase 3, Adaptive, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Immunogenicity, and Efficacy of the Nanocovax Vaccine Against COVID-19 in Volunteer Subjects 18 Years of Age and Older.

ID
Name
NNG27
Description
The purpose of this study is to evaluate the safety, immunogenicity, and efficacy of Nanocovax vaccine in volunteer subjects 18 years of age and older.
Trial arms
Trial start
2021-06-07
Estimated PCD
2022-12-07
Trial end
2022-12-07
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Nanocovax
Recombinant Protein spike (s) SARS-CoV-2 and 0,5 mg Aluminum adjuvant
Arms:
25 mcg Dose
Placebo
0,5 mg Aluminum adjuvant
Arms:
Placebo
Size
13000
Primary endpoint
Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity
From 14 days after the second dose of study intervention to the end of the study, up to 1 year
Percentage of participants reporting Serious adverse events or medically attended adverse events
From dose 1 through one year after the last dose
Geometric mean of Anti-S IgG concentrations at each time point in a subset of participants
days 0, 42, 180, 365 after vaccination
Geometric mean of SARS-CoV-2 serum neutralizing titers by Plaque reduction neutralization test (PRNT) at each time point in a subset of participants
days 0, 42 after vaccination
Eligibility criteria
Inclusion Criteria: * Be a male or female 18 years of age or older. * For females: Be of non-childbearing potential or willing to use appropriate contraceptive measures for 30 days prior to vaccination through 6 months after completion of the vaccine series. * Willingness to provide a signed, printed, and dated informed consent form. * Able and willing to participate in all activities in the clinical trial. * Participants with HIV, HBV, HCV should have a health record, determined to be stable for 6 months prior to the screening. Exclusion Criteria: * Participants with unstable pre-existing medical conditions over the three months before enrollment (condition that has worsened to require hospitalization or significant changes in therapy). * Planned administration/administration of a vaccine not foreseen by the study protocol from within 45 days before the first dose of study vaccine. * Previous vaccination with any Covid-19 vaccine. * History of COVID-19 disease. * History of allergic reactions or anaphylaxis to previous immunizations or allergies to any components of the vaccine. * Planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase through 6 months after the second immunization. * History of bleeding disorders/hemostasis or use of anticoagulants. * Currently having cancer or undergoing cancer treatment. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose (inhaled and topical steroids are allowed). * Women who are pregnant or breastfeeding.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 13000, 'type': 'ESTIMATED'}}
Updated at
2022-11-04

1 organization

2 products

1 indication

Product
Nanocovax
Indication
COVID-19
Organization
Nanogen Pharmaceutical Biotechnology
Product
Placebo