Study to Evaluate the Safety, Immunogenicity, and Efficacy of Nanocovax Vaccine Against COVID-19

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.

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS-CoV-2 Infection
• Intervention / Treatment: Biological: Nanocovax; Biological: Placebo

Detailed Description

This is a phase 3, adaptive, multicenter, randomized, double-blind, placebo control study to evaluate the safety, immunogenicity, and efficacy of the Nanocovax vaccine against COVID-19 in volunteer subjects 18 years of age and older.

Age stratified as 18-45, 45-60, and > 60 years of age.

The assessment of immunogenicity will be further expanded in a subset of Phase 3 (1000 participants).

Randomly assigned to vaccine or placebo group with a ratio of 2:1 (2 subjects injected with Nanocovax 25 mcg : 1 subject injected with placebo).

• Study Type: Interventional
• Enrollment (Actual): 13006
• Phase: Phase 3

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • Military Medical Academy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Intramuscular injection, two doses given 28 days apart	Biological: Placebo; 0,5 mg Aluminum adjuvant
Experimental: 25 mcg Dose; Intramuscular injection, two doses given 28 days apart	Biological: Nanocovax; Recombinant Protein spike (s) SARS-CoV-2 and 0,5 mg Aluminum adjuvant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Per 1000 person-years of follow-up	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants reporting solicited local and systemic reactions		7 days after each study vaccination
Percentage of participants reporting unsolicited vaccine-related ≥ Grade 2 adverse events		28 days after each study vaccination
Proportion of participants achieving ≥4-fold rise of Anti-S IgG at each time point in a subset of participants		days 0,42, 180, 365 after vaccination
T-cell responses (intracellular cytokine staining)	Change from baseline in the cell-mediated immune response in a subset of participants	days 0, 42 after vaccination
Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} asymptomatic case of COVID-19	Per 1000 person-years of follow-up	From 14 days after the second dose of study intervention to the end of the study, up to 1 year
Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} mild case of COVID-19	Per 1000 person-years of follow-up	From 14 days after the second dose of study intervention to the end of the study, up to 1 year
Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} moderate to severe case of COVID-19	Per 1000 person-years of follow-up	From 14 days after the second dose of study intervention to the end of the study, up to 1 year
Number of participants who death due to covid-19 confirmed with (RT-PCR) positive	Per 1000 person-years of follow-up	From 14 days after the second dose of study intervention to the end of the study, up to 1 year

Collaborators and Investigators

• Sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company
• Investigators: Study Director: Thuy Nguyen, MD, Medical Affairs Department

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): July 20, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: NNG27

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No