COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04977024

Chief Medical Officer

info@geovax.com

2021-07-26

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: - documented informed consent of the participant - age >=18 years - eastern cooperative oncology group (ecog) =< 2 - allogeneic or autologous hematopoietic cell transplant (hct), cellular therapy (chimeric antigen receptor [car] t-cell) recipients who are at >= 3 months of infusion date of respective regimen - platelets >= 50,000/mm^3 (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated) - white blood cells (wbcs) >= 1000/mm^3 (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated) - total bilirubin < 1.5 x upper limit of normal (uln) (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated) - aspartate aminotransferase (ast) < 2.5 x uln (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated) - alanine aminotransferase (alt) < 2.5 x uln (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated) - creatinine < 1.5 x uln (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated) - women of childbearing potential (wocbp): negative urine or serum pregnancy test (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated). if the urine pregnancy test is inconclusive a serum pregnancy test will be required - agreement by females and males of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 weeks after the last dose of protocol therapy - childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

- patients who have received second allogeneic hct are not eligible (patients who have undergone a previous autologous hct are eligible - systemic corticosteroids required for chronic conditions at doses > 0.5mg/kg/day prednisone equivalent - patients on maintenance therapies (e.g. rituximab, bruton tyrosine kinase inhibitors, janus kinase inhibitors), who may have significantly attenuated response to vaccination - subjects using investigational or licensed agents that may prevent or treat sars-cov-2 are excluded such as any previous sars-cov-2 vaccine - subjects who have had a live vaccine ≤30 days prior to administration of study vaccine or subjects who are =< 2 weeks within administration of inactivated vaccines (e.g. influenza vaccine). flu shots are allowed > 2 weeks before the first injection and > 2 weeks post 2nd injection - history of allergic reactions attributed to compounds of similar chemical or biologic composition to vaccine agents - history of adverse event with a prior smallpox vaccination - any mva vaccine or poxvirus vaccine in the last 12 months - clinically significant uncontrolled illness - females only: pregnant or breastfeeding - any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures - prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics) - anyone considered to be in a vulnerable population

2

GeoVax, Inc.

18

100

United States

High risk patients

N/A

240

Biological response

None

Phase 2

[{"arm_notes": "2;Days0-28;IM", "treatment_id": 309, "treatment_name": "Coh04s1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Days0-28;IM", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]