COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05069623

Not reported

Not reported

2021-10-06

Completed

nonRCT

Non-randomized

Parallel

Open label

multi-center

Prevention

main inclusion criteria: give informed consent by signing the informed consent form (icf) sars cov 2 vaccination status for part 1: vb10.2129 (c1): have received 2 or 3 doses of an approved mrna sars cov 2 vaccine, minimum 4.5 months (20 weeks) prior to visit 1. vb10.2210 (c2): have received 2 doses (primary vaccination) or 3 (primary and boost) doses of an approved mrna sars cov 2 vaccine, minimum 8 weeks prior to visit 1. sars cov 2 vaccination status for part 2: vb10.2129 (c1) and vb10.2210 (c2) vaccination status prior to visit 1 will be decided based on data from part 1. willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (eg, local law and regulations [county specific lock down rules] regarding covid-19), and other requirements of the study. healthy, in the clinical judgement of the investigator, based on medical history, physical examination, 12-lead electrocardiogram (ecg), vital signs (systolic/diastolic blood pressure, pulse rate, body temperature, respiratory rate), and clinical laboratory tests (blood chemistry, haematology, and urine chemistry) at visit 0 (screening). women of childbearing potential (wocbp) must have a negative pregnancy test and must agree to practice a highly effective form agree not to be vaccinated with any other vaccine during the study until 28 days after receiving the last study vaccination negative rtpcr-test for sars-cov-2 main

- have had any acute illness with or without fever, within 72 hours prior to the first vaccination - symptoms of upper respiratory infection, fever, persistent cough, shortness of breath, runny nose and breathing difficulties - breastfeeding or who plan to breastfeed during the study - have a known allergy, hypersensitivity, or intolerance to aminoglycosides - had any clinically significant or chronic medical condition or any major surgery within the past 5 years which - have any surgery planned during the study - had any chronic use of any systemic medications, including immunosuppressant's, oral corticosteroids or other immune-modifying drugs, within the 12 months prior to screening - received any vaccination within the 28 days prior to screening - received any prescription medicines (except hormonal contraception for wocbp) within 14 days prior to visit 0 (screening) or over the counter medicines (except paracetamol and acetaminophen at a dose of (≤2 grams/day)) within 48 hours of visit 0. - have a known history or a positive test of hiv 1 or 2, hep b, or hep c - have a positive rtpcr test for sars-cov-2 within 2 days of screening - documented history of previous infection with sars-cov-2 and/or who have the presence of serum ab indicative of a previous sars-cov-2 infection - have a history of hypersensitivity or have had a serious reaction to a previous vaccination - have any abnormality or permanent body art (eg, tattoo) that, would obstruct the ability to observe local reactions at the injection site. - have a condition known to put them at high risk for severe covid-19, including those with any of the following risk factors: hypertension, diabetes mellitus, chronic pulmonary disease, asthma, chronic liver disease, known stage 3 or worse chronic kidney disease - anticipating the need for immunosuppressive treatment within the next 6 months. other inclusion or exclusion criteria may apply.

4

Nykode Therapeutics ASA

18

60

Norway

Healthy volunteers

N/A

68

Incidence and frequency of local and systemic solicited adverse events (AEs);Incidence and frequency of local and systemic unsolicited AEs;Incidence and frequency of serious AEs (SAEs)

None

Phase 1/Phase 2

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