COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04934111

Jonathan Kitonsa, MBchB, MPH

Jonathan.Kitonsa@mrcuganda.org

2021-06-22

Recruiting

nonRCT

Non-randomized

Single group assignment

Open label

single-center

Prevention

inclusion criteria: healthy adults from the following aged 18-45 years on the day of screening at similar risk of acquiring sars-cov-2 infection to the general population willing and able to provide informed consent if female and of childbearing potential, willing to use a highly effective method of contraception from screening until 18 weeks after last injection if male and not sterilised, willing to avoid impregnating female partners from screening until 18 weeks after last injection willing to avoid all other vaccines from within 4 weeks before the first injection through to 22 weeks after the second injection willing and able to comply with visit schedule, complete vaccine diaries and provide samples willing to grant authorised persons access to his/her trial-related medical record and gp records either directly or indirectly

pregnant or lactating has a significant clinical history, physical finding on clinical examination during screening, or presence of a disease that is active or requires treatment to control it, including cardiac, respiratory, endocrine, metabolic, autoimmune, liver, neurological, oncological, psychiatric, immunosuppressive/immunodeficient or other disorders which in the opinion of the investigator is not compatible with healthy status, increases the risk of severe covid-19, may compromise the volunteer's safety, preclude vaccination or compromise interpretation of the immune response to vaccine. individuals with mild/moderate, well-controlled comorbidities are allowed. history of anaphylaxis or angioedema active sars-cov-2 infection at enrolment, based on dna-pcr testing discordant rdt result history of severe or multiple allergies to drugs or pharmaceutical agents history of severe local or general reaction to vaccination defined as: local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours general: fever ≥39.5 °c within 48 hours; bronchospasm; laryngeal edema; collapse; convulsions or encephalopathy within 72 hours ever received an experimental vaccine against covid-19 receipt of any immunosuppressive agents within 18 weeks of screening by any route other than topical detection of antibodies to hepatitis c detection of antibodies to hiv grade 1 and above abnormalities in routine laboratory parameters using the fda toxicity table toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. https://www.fda.gov/media/73679/download participating in another clinical trial with an investigational drug or device, or treated with an investigational drug within 28 days of screening. has received an immunisation within 28 days of screening has received an authorised covid-19 vaccine

1

MRC/UVRI and LSHTM Uganda Research Unit

18

45

Uganda

Healthy volunteers

N/A

42

Number of participants with serious Adverse Events;Number of participants with solicited local injection site reactions;Number of participants with solicited systemic reactions starting within 7 days of administration of the vaccine;Number of participants with unsolicited adverse events;Number of participants with unsolicited adverse reactions (ARs) throughout the study;The titer of serum neutralizing antibodies 2 weeks after the second vaccination in the SARS-CoV-2 pseudovirus-based neutralization assay;The titer of vaccine-induced serum IgG binding antibody responses to the SARS-CoV-2 S glycoprotein 2 weeks after the first and second vaccinations

None

Phase 1

[{"arm_notes": "5.0ug;2;Weeks0-4", "treatment_id": 740, "treatment_name": "Lnp-ncovsarna-02 vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]