A Study Looking at the Effectiveness and Safety of a COVID-19 Vaccine in South African Adults

  • STATUS
    Recruiting
  • days left to enroll
    62
  • participants needed
    4400
  • sponsor
    Novavax
Updated on 26 January 2021

Summary

This is a study to evaluate the effectiveness and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in a minimum of approximately 2,960 to a maximum of approximately 4,164 healthy HIV-negative (HIV-) adult participants and in approximately 240 medically stable HIV-positive (HIV+) adult participants in up to 15 sites across South Africa. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in these study populations. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections over the course of the study.

Details
Condition *COVID-19, Covid-19, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection
Treatment Placebo, SARS-CoV-2 rS/Matrix-M1 Adjuvant
Clinical Study IdentifierNCT04533399
SponsorNovavax
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

All subjects
to 64 years at screening for Cohort 2 and 18 to 84 years at screening for Cohort 1
Body mass index (BMI) of 17 to 40 kg/m
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, and free of opportunistic infections in the 1 year prior to first study vaccination
Have a HIV-1 viral load < 1000 copies/mL within 45 days of randomization in the study

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
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. NOTE: Hypertension [elevated BP] grade 1 (systolic BP 159 mmHg; diastolic BP 99 mmHg) according to the South African Hypertension Society's Practice Guidelines is NOT exclusionary
Congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years
Chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbation of any severity in the past 2 years
Evidence of unstable coronary artery disease in the past 3 months, as determined by the investigator; NOTE: Stable coronary heart disease is NOT exclusionary
Asthma requiring regular/chronic control medication (eg, short-acting beta2-agonist [SABA] > 2 days per week; or any chronic use of inhaled corticosteroids [ICS], long-acting beta2-agonist [LABA], leukotriene receptor antagonist [LTRA], or oral corticosteroids), and/or worsening of asthma symptoms in the past 3 months; NOTE: Asthma not requiring regular/chronic control medication, and not requiring SABA > 2 days per week, and not demonstrating worsening of symptoms in the past 3 months, will NOT be excluded
Type 1 or 2 diabetes (adult onset) requiring treatment with insulin; NOTE: Non-insulin dependent type 2 diabetes is NOT exclusionary
Chronic kidney disease/renal insufficiency
Chronic gastrointestinal and hepatic diseases
Chronic neurological diseases (such as multiple sclerosis, dementia, transient ischemic attacks, Parkinson's disease, degenerative neurological conditions, neuropathy, or epilepsy), or a history of stroke within 12 months with residual symptoms, or previous neurological disorder within 12 months with residual symptoms; NOTE: History of migraine or chronic headaches, or nerve root compression that have been stable on treatment for the last 4 weeks are NOT exclusionary
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 study vaccination
Any autoimmune or immunodeficiency disease/condition (excluding HIV in HIV-positive patients)
Chronic (more than 14 days continuous) administration of immunosuppressant, systemic glucocorticosteroids, or other immune-modifying drugs within 90 days prior to first study vaccination (excluding HAART in HIV-positive subjects). NOTE: An immunosuppressant dose of glucocorticoid is defined as a systemic dose 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted
Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination (excluding HAART in HIV-positive subjects)
Acute respiratory and/or non-respiratory illness consistent with potential COVID-19, concurrent with or within 14 days prior to first study vaccination, or documented temperature of > 38C during this period
Known blood clotting disorder
Active cancer (malignancy) within 3 years prior to first study vaccination (with the exception of adequately treated non-melanoma skin cancers, as assessed by the investigator)
Any known allergies to products contained in the investigational product, or latex allergy, or any history of anaphylaxis in relation to any previous vaccination
Women who are breastfeeding or who are pregnant at the time of screening, or plan to become pregnant within the first 6 months of the study
History of alcohol abuse or drug addiction within 2 years prior to the first study vaccination
Any condition (other than HIV in HIV-positive subjects) that, in the opinion of the investigator, would pose a health risk to the subject if they participate in the study, or could interfere with evaluation of the study vaccine or interpretation of study results
Study team member or first-degree relative of any study member
Other protocol-defined inclusion/exclusion criteria may apply
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