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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 June 2021
• Main ID: NCT04922788
• Date of registration: 08/06/2021
• Prospective Registration: Yes
• Primary sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company
• Public title: Study to Evaluate the Safety, Immunogenicity, and Efficacy of Nanocovax Vaccine Against COVID-19
• Scientific 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.
• Date of first enrolment: June 7, 2021
• Target sample size: 13000
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04922788
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Vietnam

Contacts

• Name: Men Chu, PhD

• Name: Nhan Ho, PhD

• Name: Thuy Nguyen, MD
• Affiliation: Medical Affairs Department

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

COVID-19

SARS-CoV-2 Infection

Intervention(s)

Biological: Nanocovax

Biological: Placebo

Primary Outcome(s)

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]

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]

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 [Time Frame: 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 [Time Frame: From dose 1 through one year after the last dose]

Secondary Outcome(s)

Number of participants who death due to covid-19 confirmed with (RT-PCR) positive [Time Frame: 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} asymptomatic case of COVID-19 [Time Frame: 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 [Time Frame: 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 [Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year]

Percentage of participants reporting solicited local and systemic reactions [Time Frame: 7 days after each study vaccination]

Percentage of participants reporting unsolicited vaccine-related = Grade 2 adverse events [Time Frame: 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 [Time Frame: days 0,42, 180, 365 after vaccination]

T-cell responses (intracellular cytokine staining) [Time Frame: days 0, 42 after vaccination]

Secondary ID(s)

NNG27

Source(s) of Monetary Support

Please refer to primary and secondary sponsors