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

NCT04922788 | Completed Phase 3 DMC

• 1 other identifier: NNG27
• Study Type: interventional
• Target: 13,006
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SARS-CoV-2 Infection; COVID-19

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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)

  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

  From 14 days after the second dose of study intervention to the end of the study, up to 1 year

Study Arms (2)

25 mcg Dose

EXPERIMENTAL

Intramuscular injection, two doses given 28 days apart

Biological: Nanocovax

Placebo

PLACEBO COMPARATOR

Intramuscular injection, two doses given 28 days apart

Biological: Placebo

Interventions

Nanocovax BIOLOGICAL

Recombinant Protein spike (s) SARS-CoV-2 and 0,5 mg Aluminum adjuvant

25 mcg Dose

Placebo BIOLOGICAL

0,5 mg Aluminum adjuvant

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanogen Pharmaceutical Biotechnology Joint Stock Company: lead

Study Sites (1)

Military Medical Academy

Hanoi, Vietnam

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Thuy Nguyen, MD

  Medical Affairs Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 11, 2021
• Study Start: June 7, 2021
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

VN (1)