COVID-19
Conditions
Interventions
Cohort 1 HIV negative
Cohort 2 HIV positive
Sponsors
Novavax Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. • Medically stable at screening, as determined by the investigator. • Have a HIV-1 viral load < 1000 copies/mL within 45 days of randomization in the stud
Exclusion criteria
Exclusion criteria: • 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; i. chronic neurological diseases (such as multiple sclerosis, dementia, transient ischemic attacks, Parkinson's disease, degenerative neurological conditions, neuropathy, epilepsy, or a history of stroke or previous neurological disorder within the past 12 months with residual symptoms). Subjects with a history of migraine or chronic headaches, or nerve root compression that have been stable on treatment for the last 4 weeks are not excluded. • Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination. • Prior receipt of investigational or approved COVID-19 vaccine at any time. • History of a diagnosis of suspected or confirmed COVID-19. • Received influenza (flu) vaccination within 14 days prior to first study vaccination; or any other vaccine within 4 weeks prior to first study vaccination; or planned vaccination with 5 weeks after first st
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive (+) PCR-confirmed SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19 in serologically naïve (to SARS-CoV-2) healthy HIV-negative and medically stable HIV-positive adult subjects, analyzed overall, with a lower bound confidence interval (CI) of > 0, from 7 days after the second vaccine dose (e.g, Day 28) until the endpoint-driven efficacy analysis is triggered by the occurrence of a prespecified number of blinded endpoints across the 2 study vaccine arms and/or at prespecified time points. Except as otherwise specified, Cohort 1 (HIV-negative subjects) and Cohort 2 (HIV-positive subjects) will be analyzed overall and as separate populations.;Numbers and percentages (with 95% CIs) of healthy HIV-negative and medically stable HIV-positive adult subjects, with solicited AEs (local, systemic) for 7 days following each vaccination (Days 0 and 21) by severity score, duration, and peak intensity in healthy HIV-negative and medically stable HIV-positive adult subjects, regardless of baseline serostatus and stratified by baseline serostatus. ;Numbers and percentages (with 95% CI) of subjects with unsolicited AEs (e.g, treatment-emergent, serious, suspected unexpected serious, those of special interest, MAAEs) through Day 49 by Medical Dictionary for Regulatory Activities (MedDRA) classification, severity score, and relatedness in healthy HIV-negative and medically stable HIV-positive adult subjects, regardless of baseline serostatus and stratified by baseline serostatus. | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive (+) PCR-confirmed SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19 in serologically naïve (to SARS-CoV-2) healthy HIV-negative and medically stable HIV-positive adult subjects, analysed separately, with a lower bound confidence interval (CI) of > 0, from 7 days after the second vaccine dose (e.g, Day 28) until the endpoint-driven efficacy analysis is triggered by the occurrence of a prespecified number of blinded endpoints across the 2 study vaccine arms and/or at prespecified time points.;Positive (+) PCR-confirmed SARS-CoV-2 illness with symptomatic moderate or severe COVID-19 in serologically naïve (to SARS-CoV-2), healthy HIV-negative and medically stable HIV-positive adult subjects, with a lower bound CI > 0, from 7 days after the second vaccine dose (e.g, Day 28) until the endpoint- driven efficacy analysis is triggered by the occurrence of a prespecified number of blinded endpoints across the 2 study vaccine arms and/or at prespecified time points ;Positive (+) PCR-confirmed SARS-CoV-2 illness with asymptomatic, symptomatic virologically confirmed, mild, moderate, or severe COVID-19 in serologically naïve (to SARS-CoV-2) healthy HIV-negative and medically stable HIV-positive adult subjects from 7 days after the second vaccine dose (eg, Day 28). ;(+) PCR-confirmed SARS-CoV-2 with COVID-19 in serologically naïve (to SARS-CoV-2) healthy HIV-negative and medically stable HIV-positive adult subjects, in terms of individual strata of symptomatic virologically confirmed, mild, moderate, or severe categories of COVID-19 as previously described.;(+) PCR-confirmed SARS-CoV-2 with COVID-19 in serologically naïve (to SARS-CoV-2) healthy HIV-negative and medically stable HIV-positive adult subjects, requiring hospitalization (regardless of severity).;Incidence, maximum severity score, and symptom duration of SARS-CoV-2 infection by classification of symptomatic virologically confirmed, mild, moderate, and/or severe COVID-19 in serological | — |
Countries
South Africa
Contacts
Public ContactGary Albert
Central Contact Person
Outcome results
None listed