SARS-CoV-2 InfectionPhase 3NCT04922788
Study to Evaluate the Safety, Immunogenicity, and Efficacy of Nanocovax Vaccine Against COVID-19
A Phase 3 study testing Nanocovax in people with SARS-CoV-2 Infection and COVID-19, run by Nanogen Pharmaceutical Biotechnology Joint Stock Company at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection, COVID-19
- What is being tested?
- Nanocovax
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13,006 participants
- Where
- 1 siteVietnam
- Study dates
- 7 Jun 2021to 20 Jul 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- Nanocovax, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanocovaxBiological
Recombinant Protein spike (s) SARS-CoV-2 and 0,5 mg Aluminum adjuvant
PlaceboBiological
0,5 mg Aluminum adjuvant
| Study group | Role | What they receive |
|---|---|---|
| 25 mcg Dose | Experimental | Intramuscular injection, two doses given 28 days apart Receives: Biological: Nanocovax |
| Placebo | Placebo comparator | Intramuscular injection, two doses given 28 days apart Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From dose 1 through one year after the last dose
Geometric mean of Anti-S IgG concentrations at each time point in a subset of participants
Measured: 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
Measured: days 0, 42 after vaccination
Secondary outcomes (8)
Percentage of participants reporting solicited local and systemic reactions
Measured: 7 days after each study vaccination
Percentage of participants reporting unsolicited vaccine-related ≥ Grade 2 adverse events
Measured: 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
Measured: days 0,42, 180, 365 after vaccination
T-cell responses (intracellular cytokine staining)
Change from baseline in the cell-mediated immune response in a subset of participants
Measured: days 0, 42 after vaccination
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
Measured: 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
Per 1000 person-years of follow-up
Measured: 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
Per 1000 person-years of follow-up
Measured: From 14 days after the second dose of study intervention to the end of the study, up to 1 year
Number of participants who death due to covid-19 confirmed with (RT-PCR) positive
Per 1000 person-years of follow-up
Measured: From 14 days after the second dose of study intervention to the end of the study, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start7 Jun 2021
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thuy Nguyen, MD, Study director, Medical Affairs Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922788
- Sponsor's protocol ID
- NNG27
- Status last verified
- Mar 2025
- First submitted
- 8 Jun 2021
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04922788
- Acronym / sponsor ID
- NNG27
- Conditions
- SARS-CoV-2 Infection, COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,006 participants (actual)
- Lead sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock CompanyIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25 mcg Dose | Experimental | Biological: NanocovaxIntramuscular injection, two doses given 28 days apart |
| Placebo | Placebo comparator | Biological: PlaceboIntramuscular injection, two doses given 28 days apart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanocovaxRecombinant Protein spike (s) SARS-CoV-2 and 0,5 mg Aluminum adjuvant | Biological | 25 mcg Dose |
| Placebo0,5 mg Aluminum adjuvant | Biological | Placebo |
Primary outcome
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
Per 1000 person-years of follow-up
Percentage of participants reporting Serious adverse events or medically attended adverse events
Time frame: From dose 1 through one year after the last dose
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
8 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thuy Nguyen, MD study director
Medical Affairs Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nanocovax in people with SARS-CoV-2 Infection and COVID-19, run by Nanogen Pharmaceutical Biotechnology Joint Stock Company at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.