COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04776317

Not reported

Not reported

2021-03-01

Completed

nonRCT

Non-randomized

Parallel

Open label

multi-center

Prevention

inclusion criteria: subjects eligible to participate in this trial must meet all of the following inclusion criteria: provide written informed consent prior to initiation of any study procedures able and willing (in the investigator's opinion) to comply with all study requirements are men or non-pregnant women aged 18 years or older at enrollment are in good health* *as defined by absence of clinically significant medical conditions defined by the cdc as increasing risk for severe corona virus disease-19 (covid-19) (see exclusion criteria), or other acute or chronic medical conditions determined by medical history, physical examination (pe), screening laboratory test results, and/or clinical assessment of the investigator that are either listed as exclusion criteria below or in the opinion of the investigator would increase risk for study participation or affect the assessment of the safety of subjects. chronic medical conditions should be stable for the last 60 days (no hospitalizations, emergency room or urgent care for condition, or invasive medical procedures). any prescription change that is due to change of health care provider, insurance company, etc., or done for financial reasons, and in the same class of medication, will not be considered a deviation of this inclusion criterion. any change in prescription medication due to improvement of a disease outcome, as determined by the participating site pi or appropriate sub- investigator, will not be considered a deviation of this inclusion criterion. subjects may be on chronic or as needed (prn) medications if, in the opinion of the participating site pi or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity, and do not indicate a worsening of medical diagnosis/condition. similarly, medication changes in the 60 days prior to enrollment as well as subsequent to enrollment and study vaccination are acceptable provided the change was not precipitated by deterioration in the chronic medical condition, and there is no anticipated additional risk to the subject or interference with the evaluation of responses to study vaccination. agree to refrain from blood donation during the course of the study plan to remain living in the area for the duration of the study women of childbearing potential (wocbp)* must plan to avoid pregnancy for at least 60 days after the last study vaccination and be willing to use an adequate method of contraception** consistently for 30 days prior to first study vaccine and for at least 60 days after the last study vaccine. *not sterilized via bilateral oophorectomy, tubal ligation/salpingectomy, hysterectomy, or successful essure (r) placement (permanent, non-surgical, non-hormonal sterilization with documented radiological confirmation test at least 90 days after the procedure); still menstruating; or < 1 year has passed since the last menses if menopausal **acceptable methods of birth control include the following: oral contraceptives, injection hormonal contraceptive, implant hormonal contraceptive, hormonal patch, intrauterine device, spermicidal products and barrier methods (such as cervical sponge, diaphragm, or condom with spermicide), abstinence, monogamous with a vasectomized partner, non-male sexual relationship women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each study vaccination vital signs within acceptable ranges: pulse > 50 and = / < 100 beats per minute systolic blood pressure (bp) = / < 140 millimeters of mercury (mmhg) diastolic bp = / < 90 mmhg oral temperature < 37.8 degrees celsius (100.0 degrees fahrenheit) clinical screening lab evaluations (white blood cell (wbc), hemoglobin (hgb), platelets (plt), alanine aminotransferase (alt), aspartate aminotransferase (ast), alkaline phosphatase (alp), total bilirubin (t bili), creatine kinase (ck), serum creatinine (cr) and prothrombin time (pt)/partial thromboplastin time (ptt)) are within acceptable normal reference ranges at the clinical lab being used* *with the exception that alt, ast, alp, and creatinine values that are below the reference range will not be exclusionary as these values below reference range are clinically insignificant. any other screening lab value outside the reference range that is thought to be clinically insignificant by a site investigator must be discussed with the dmid medical officer prior to enrollment. must agree to genetic testing and storage of samples for secondary research received at least 2 doses of eua/licensed mrna vaccines or at least 1 dose of ad26 vaccine followed by an mrna booster, with the last covid-19 vaccine dose given at least 112 days prior to enrollment (stage 2 only), as confirmed via cdc vaccination card or other appropriate documentation. subjects may or may not have been previously infected with sars-cov-2. a subject must meet all of the following criteria to be eligible for leukapheresis: written informed consent for leukapheresis is provided weight > / = 110 pounds screening laboratory evaluations are within acceptable ranges at the site where the leukapheresis procedure will be performed negative urine or serum pregnancy test at screening and on the day of the leukapheresis procedure for women of childbearing potential adequate bilateral antecubital venous access no use of blood thinners, aspirin, or nonsteroidal anti-inflammatory drugs (nsaids) at least 5 days before the leukapheresis procedure

subjects eligible to participate in this trial must not meet any of the following

15

National Institute of Allergy and Infectious Diseases (NIAID)

18

60

United States

Healthy volunteers

N/A

81

Occurrence of Adverse Events of Special Interest (AESIs);Occurrence of clinical safety laboratory adverse events by severity grade;Occurrence of Serious Adverse Events (SAEs);Occurrence of solicited local reactogenicity adverse events (AEs);Occurrence of solicited systemic reactogenicity adverse events (AEs);Occurrence of unsolicited adverse events (AEs)

None

Phase 1

[{"arm_notes": "Stage 1 (Na\u00efve) Group 1\n5 x 10^10 viral particles of ChAdV68-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 30 mcg of SAM-LNP-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 29 in participants from 18 to 60 years of age. N=4", "treatment_id": 2279, "treatment_name": "Chadv68-s+sam-lnp-s", "treatment_type": "Non replicating viral vector+rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Stage 1 (Na\u00efve) Group 3A\n30 mcg of SAM-LNP-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 30 mcg of SAM-LNP-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 29 in participants from 18 to 60 years of age. N=3", "treatment_id": 1144, "treatment_name": "Sam-lnp-s", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Stage 1 (Na\u00efve) Group 3B\n30 mcg SAM-LNP-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 3 mcg of SAM-LNP-S administered through 0.25 mL intramuscular injection in the deltoid muscle on or after Day 85 and no later than Day 130 in participants from 18 to 60 years of age. N=7", "treatment_id": 1144, "treatment_name": "Sam-lnp-s", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Stage 1 (Na\u00efve) Group 4\n10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 3 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on or after Day 85 and no later than Day 130 in participants from 18 to 60 years of age. N=3", "treatment_id": 1145, "treatment_name": "Sam-lnp-s-tce", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 13\n5 x 10^10 viral particles of ChAdV68-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and on or after Day 113 in participants older than 60 years of age. N=7-10", "treatment_id": 270, "treatment_name": "Chadv68-s-tce", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 14\n1 x 10^11 viral particles of ChAdV68-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=7-10", "treatment_id": 270, "treatment_name": "Chadv68-s-tce", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 15\n5 x 10^11 viral particles of ChAdV68-S-TCE administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=7-10", "treatment_id": 270, "treatment_name": "Chadv68-s-tce", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 10A,B\n6 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=8-12", "treatment_id": 1145, "treatment_name": "Sam-lnp-s-tce", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 11A,B\n10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=8-12", "treatment_id": 1145, "treatment_name": "Sam-lnp-s-tce", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 12A,B\n10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 10 mcg SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 57 in participants older than 60 years of age. N=8-12", "treatment_id": 1145, "treatment_name": "Sam-lnp-s-tce", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 9\n3 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=8", "treatment_id": 1145, "treatment_name": "Sam-lnp-s-tce", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 5\n3 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 60 years of age. N=10", "treatment_id": 1145, "treatment_name": "Sam-lnp-s-tce", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 6\n6 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 60 years of age. N=10", "treatment_id": 1145, "treatment_name": "Sam-lnp-s-tce", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 7A,B\n10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 60 years of age. N=8-12", "treatment_id": 1145, "treatment_name": "Sam-lnp-s-tce", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 8A,B\n10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 57 in participants from 18 to 60 years of age. N=8-12", "treatment_id": 1145, "treatment_name": "Sam-lnp-s-tce", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]