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

NCT ID: NCT04922788

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 13006 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-07
• Study Completion Date: 2022-07-20

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.

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).

Conditions

SARS-CoV-2 Infection; COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

25 mcg Dose

Intramuscular injection, two doses given 28 days apart

Group Type: EXPERIMENTAL

Nanocovax

Intervention Type: BIOLOGICAL

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

Placebo

Intramuscular injection, two doses given 28 days apart

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

0,5 mg Aluminum adjuvant

Interventions

Nanocovax

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

Intervention Type: BIOLOGICAL

Placebo

0,5 mg Aluminum adjuvant

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanogen Pharmaceutical Biotechnology Joint Stock Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thuy Nguyen, MD

Role: STUDY_DIRECTOR

Medical Affairs Department

Locations

Military Medical Academy

Hanoi, , Vietnam

Countries

Vietnam

Other Identifiers

NNG27

Identifier Type: -

Identifier Source: org_study_id