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

COVID-19 Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04922788
• Other study ID #: NNG27
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 7, 2021
• Est. completion date: December 7, 2022

Study information

• Verified date: November 2022
• Source: Nanogen Pharmaceutical Biotechnology Joint Stock Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13000
• Est. completion date: December 7, 2022
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Biological:
• Nanocovax
Recombinant Protein spike (s) SARS-CoV-2 and 0,5 mg Aluminum adjuvant
• Placebo
0,5 mg Aluminum adjuvant

Locations

Country	Name	City	State
Vietnam	Military Medical Academy	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Nanogen Pharmaceutical Biotechnology Joint Stock Company

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of participants reporting Serious adverse events or medically attended adverse events		From dose 1 through one year after the last dose
Primary	Geometric mean of Anti-S IgG concentrations at each time point in a subset of participants		days 0, 42, 180, 365 after vaccination
Primary	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	Percentage of participants reporting solicited local and systemic reactions		7 days after each study vaccination
Secondary	Percentage of participants reporting unsolicited vaccine-related = Grade 2 adverse events		28 days after each study vaccination
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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