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

Primary Purpose

SARS-CoV-2 Infection, COVID-19

Status

Active

Phase

Phase 3

Locations

Vietnam

Study Type

Interventional

Intervention

Nanocovax

Placebo

About this trial

This is an interventional prevention trial for SARS-CoV-2 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Military Medical Academy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

25 mcg Dose

Placebo

Arm Description

Intramuscular injection, two doses given 28 days apart

Outcomes

Primary Outcome Measures

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

Percentage of participants reporting Serious adverse events or medically attended adverse events

Geometric mean of Anti-S IgG concentrations at each time point in a subset of participants

Geometric mean of SARS-CoV-2 serum neutralizing titers by Plaque reduction neutralization test (PRNT) at each time point in a subset of participants

Secondary Outcome Measures

Percentage of participants reporting solicited local and systemic reactions

Percentage of participants reporting unsolicited vaccine-related ≥ Grade 2 adverse events

Proportion of participants achieving ≥4-fold rise of Anti-S IgG at each time point in a subset of participants

T-cell responses (intracellular cytokine staining)

Change from baseline in the cell-mediated immune response in a subset of participants

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

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

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

Number of participants who death due to covid-19 confirmed with (RT-PCR) positive

Per 1000 person-years of follow-up

Full Information

NCT ID

NCT04922788

First Posted

June 8, 2021

Last Updated

November 3, 2022

Sponsor

Nanogen Pharmaceutical Biotechnology Joint Stock Company

1. Study Identification

Unique Protocol Identification Number

NCT04922788

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 7, 2021 (Actual)

Primary Completion Date

December 7, 2022 (Anticipated)

Study Completion Date

December 7, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nanogen Pharmaceutical Biotechnology Joint Stock Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS-CoV-2 Infection, COVID-19

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

13000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

25 mcg Dose

Arm Type

Experimental

Arm Description

Intramuscular injection, two doses given 28 days apart

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intramuscular injection, two doses given 28 days apart

Intervention Type

Biological

Intervention Name(s)

Nanocovax

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

0,5 mg Aluminum adjuvant

Primary Outcome Measure Information:

Title

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

Description

Per 1000 person-years of follow-up

Time Frame

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

Title

Percentage of participants reporting Serious adverse events or medically attended adverse events

Time Frame

From dose 1 through one year after the last dose

Title

Geometric mean of Anti-S IgG concentrations at each time point in a subset of participants

Time Frame

days 0, 42, 180, 365 after vaccination

Title

Geometric mean of SARS-CoV-2 serum neutralizing titers by Plaque reduction neutralization test (PRNT) at each time point in a subset of participants

Time Frame

days 0, 42 after vaccination

Secondary Outcome Measure Information:

Title

Percentage of participants reporting solicited local and systemic reactions

Time Frame

7 days after each study vaccination

Title

Percentage of participants reporting unsolicited vaccine-related ≥ Grade 2 adverse events

Time Frame

28 days after each study vaccination

Title

Proportion of participants achieving ≥4-fold rise of Anti-S IgG at each time point in a subset of participants

Time Frame

days 0,42, 180, 365 after vaccination

Title

T-cell responses (intracellular cytokine staining)

Description

Change from baseline in the cell-mediated immune response in a subset of participants

Time Frame

days 0, 42 after vaccination

Title

Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} asymptomatic case of COVID-19

Description

Per 1000 person-years of follow-up

Time Frame

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

Title

Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} mild case of COVID-19

Description

Per 1000 person-years of follow-up

Time Frame

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

Title

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

Description

Per 1000 person-years of follow-up

Time Frame

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

Title

Number of participants who death due to covid-19 confirmed with (RT-PCR) positive

Description

Per 1000 person-years of follow-up

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thuy Nguyen, MD

Organizational Affiliation

Medical Affairs Department

Official's Role

Study Director

Facility Information:

Facility Name

Military Medical Academy

City

Hanoi

Country

Vietnam

12. IPD Sharing Statement

Learn more about this trial

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

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