COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04922788

Not reported

Not reported

2021-06-11

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

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.

- 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.

2

Nanogen Pharmaceutical Biotechnology Joint Stock Company

18

100

Vietnam

Healthy volunteers

N/A

13000

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

None

Phase 3

[{"arm_notes": "25 mcg + 0,5 mg adjuvant aluminium;2;Days0-28;IM", "treatment_id": 857, "treatment_name": "Nanocovax", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]