A Phase 2A/B, Randomized, Observer-blinded, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in South African Adult Subjects Living Without HIV; and Safety and Immunogenicity in Adults Living With HIV. COVID-19

ovavax Inc0 sites4,704 target enrollmentAugust 25, 2020

ConditionsCOVID-19

Overview

No summary available.

Registry

who.int

Start Date

August 25, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

ovavax Inc

•All subjects:
•Body mass index (BMI) of 17 to 40 kg/m².
•Provides informed consent prior to study participation and is willing to comply with study procedures, including potential home visits.
•Women of child\-bearing potential must agree not to have sexual intercourse with men, or must consistently use an agreed method of contraception from at least 21 days prior to enrolment in the study, through 6 months after the last vaccination.
•HIV\-negative subjects only:
•Documentation of HIV\-negative test result by a method approved in South Africa.
•Healthy at study screening, as determined by the investigator.
•HIV\-positive subjects only:
•Documentation of HIV\-positive test result by a method approved in South Africa.
•Receiving highly active antiretroviral therapy (HAART) and has been using the same regimen for at least 8 weeks before screening. Changes in antiretroviral dosage within 8 weeks of entering the study are allowed, as are exchanges in pharmacological formulations.

•Any current acute illness requiring medical or surgical care, or chronic illness (excluding HIV in HIV\-positive subjects) that requires changes in medication in the past 2 months indicating that chronic illness/disease is not stable.
•Chronic disease, including:
•a. hypertension (elevated blood pressure \[BP]) \= grade 2 (systolic BP \= 160 mmHg; and/or diastolic BP \= 100 mmHg) according to the South African Hypertension Society’s Practice Guidelines;
•b. congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years;
•c. chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbation of any severity in the past 2 years. Stable coronary heart disease is NOT exclusionary;
•d. evidence of unstable coronary artery disease in the past 3 months, as determined by the investigator;
•e. asthma requiring regular/chronic control medication;
•f. Type 1 and 2 diabetes (adult onset) requiring treatment with insulin;
•g. chronic kidney disease/renal insufficiency;
•h. Chronic gastrointestinal and hepatic diseases;