Clinical trial NCT04922788: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: SARS-CoV-2 Infection
COVID-19
Lead sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company
Sponsor class: INDUSTRY
First posted: 2021-06-11
Enrollment: 13006
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: 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
timeFrame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year
measure: Percentage of participants reporting Serious adverse events or medically attended adverse events
timeFrame: From dose 1 through one year after the last dose
measure: Geometric mean of Anti-S IgG concentrations at each time point in a subset of participants
timeFrame: days 0, 42, 180, 365 after vaccination
measure: Geometric mean of SARS-CoV-2 serum neutralizing titers by Plaque reduction neutralization test (PRNT) at each time point in a subset of participants
timeFrame: days 0, 42 after vaccination
Secondary outcomes:
measure: Percentage of participants reporting solicited local and systemic reactions
timeFrame: 7 days after each study vaccination
measure: Percentage of participants reporting unsolicited vaccine-related ≥ Grade 2 adverse events
timeFrame: 28 days after each study vaccination
measure: Proportion of participants achieving ≥4-fold rise of Anti-S IgG at each time point in a subset of participants
timeFrame: days 0,42, 180, 365 after vaccination
measure: T-cell responses (intracellular cytokine staining)
timeFrame: days 0, 42 after vaccination
measure: Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} asymptomatic case of COVID-19
timeFrame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year
measure: Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} mild case of COVID-19
timeFrame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year
measure: 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
timeFrame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year
measure: Number of participants who death due to covid-19 confirmed with (RT-PCR) positive
timeFrame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Military Medical Academy
Study officials:
affiliation: Medical Affairs Department
name: Thuy Nguyen, MD
role: STUDY_DIRECTOR
References: