COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=19304

Tariro Makadzange

tariro.makadzange@crmgresearch.com

2021-12-06

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Prevention

Male or Female aged above 18 years (inclusive) Phase I: Participants aged 18 to 45 years (both inclusive) Phase II: Participants aged above 18 years (inclusive) (Strata 1: 18 to 59 years (both inclusive), Strata 2: above 60 years (inclusive). Healthy participants as determined by medical history, physical examination, vital signs and clinical and laboratory examination. Test negative for SARS-CoV-2 infection by RT-PCR test at screening Test negative for -SARS-CoV-2 IgG antibody by serology test at screening Capable and willing to provide written informed consent prior to the performance of any study-specific procedures.

Receipt of medications or vaccines intended to prevent or treat COVID-19 infection in the past. Fever (non-axillary temperature > 37.5 ºC) or any other symptoms of infection that have not completely resolved including respiratory symptoms/illnesses within the past 3 days from randomization (Day 0) Participants with a BMI > 35 kg/m2. A major or clinically significant medical condition. Individuals currently working in occupations with high risk of exposure to SARS-CoV Pregnant or lactating women or willingness/intention to become pregnant during the study. History of allergy to any component of the RBD SARS-CoV-2 HBsAg VLP Vaccine, or serious adverse reactions to the vaccine A history of anaphylaxis to a vaccine, food, drug, toxin or other exposure Known hypersensitivity reactions to yeast. Positive test result at screening for HIV ½ antibody, HBsAg or HCV Ab Clinical laboratory tests of blood and urine not within the normal range and show clinically relevant deviations as judged by the Investigator. History of demyelinating disease or Guillain Barre syndrome Eczema or other significant skin lesion or infection at the site/s of vaccination Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination Positive screen for drugs of abuse or alcohol (breath test) at screening and randomization (Day 0). (Drugs of abuse include amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, phencyclidine, and tetrahydrocannabinol). Participants who currently smoke at least 10 cigarettes or equivalent per day Receipt of blood/blood products/immunoglobulins or donation of blood/blood products 8 weeks prior to vaccination or planned receipt or donation during the study period Any other medical condition which in the opinion of the Investigator may affect the subject’s safety or study participation and conduct.

7

Serum Institute of India

18

100

Zimbabwe

Healthy volunteers

N/A

350

Safety and reactogenicity

| Declared number of arm (7.0) differs from found arms (8.0)

Phase 1

[{"arm_notes": "1.25\u00b5g with SWE adjuvant;2;Days0-180", "treatment_id": 1070, "treatment_name": "Rbd sars-cov-2 hbsag vlp vaccine", "treatment_type": "Virus-like particle", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2.5\u00b5g with SWE adjuvant;2;Days0-180", "treatment_id": 1070, "treatment_name": "Rbd sars-cov-2 hbsag vlp vaccine", "treatment_type": "Virus-like particle", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1.25\u00b5g with SWE adjuvant;3;Days0-28-180", "treatment_id": 1070, "treatment_name": "Rbd sars-cov-2 hbsag vlp vaccine", "treatment_type": "Virus-like particle", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2.5\u00b5g with SWE adjuvant;2;Days0--28-180", "treatment_id": 1070, "treatment_name": "Rbd sars-cov-2 hbsag vlp vaccine", "treatment_type": "Virus-like particle", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "10\u00b5g with aluminium hydroxide adjuvant;3;Days0-28-56", "treatment_id": 1070, "treatment_name": "Rbd sars-cov-2 hbsag vlp vaccine", "treatment_type": "Virus-like particle", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "25\u00b5g with aluminium hydroxide adjuvant;3;Days0-28-56", "treatment_id": 1070, "treatment_name": "Rbd sars-cov-2 hbsag vlp vaccine", "treatment_type": "Virus-like particle", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Days0-28;IM", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]