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Trial record 22 of 28 for:    Novavax

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04533399
Recruitment Status : Recruiting
First Posted : August 31, 2020
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Novavax

Brief 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 approximately 2,664 healthy HIV-negative (HIV-) adult participants and in approximately 240 medically stable HIV-positive (HIV+) adult participants in up to 10 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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection COVID-19 Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2904 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : August 17, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Cohort 1 (HIV negative) 5 μg SARS-CoV-2 rS/Matrix-M1 Adjuvant
2 doses of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21.
Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant
Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21.
Other Name: NVX-CoV2373

Placebo Comparator: Cohort 1 (HIV negative) Placebo
2 doses of Placebo (Saline), 1 dose each on Days 0 and 21.
Other: Placebo
Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21.
Other Name: Sodium chloride 0.9% (BP, sterile)

Experimental: Cohort 2 (HIV positive) 5 μg SARS-CoV-2 rS/Matrix-M1 Adjuvant
2 doses of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21.
Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant
Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21.
Other Name: NVX-CoV2373

Placebo Comparator: Cohort 2 (HIV positive) Placebo
2 doses of Placebo (Saline), 1 dose each on Days 0 and 21.
Other: Placebo
Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21.
Other Name: Sodium chloride 0.9% (BP, sterile)




Primary Outcome Measures :
  1. Cohort 1: HIV- Participants with Symptomatic Mild, Moderate, or Severe COVID-19 [ Time Frame: Day 28 to Day 386 ]
    Number of human immunodeficiency virus negative (HIV-) participants with first occurrence of positive (+) polymerase chain reaction (PCR), (+) PCR-confirmed, SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19 assessed from Day 28 (7 days after second vaccination dose) through the length of the study.

  2. Cohort 1: HIV- Participants with Symptomatic Moderate or Severe COVID-19 [ Time Frame: Day 28 to Day 386 ]
    Number of HIV- participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with symptomatic moderate or severe COVID-19 assessed from Day 28 (7 days after second vaccination) through the length of the study.

  3. Cohort 1: HIV- Participants with Solicited Adverse Events (AEs) [ Time Frame: 28 days ]
    Numbers and percentages (with 95% confidence intervals [CIs]) of HIV- participants with solicited AEs, local and systemic, for 7 days following each vaccination (Days 0 and 21) by severity score, duration, and peak intensity.

  4. Cohort 1: HIV- Participants with Unsolicited AEs [ Time Frame: 35 days ]
    Numbers and percentages (with 95% CI) of HIV- participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, MAAEs) through Day 35 by Medical Dictionary for Regulatory Activities (MedDRA) classification, severity score, and relatedness.

  5. Cohort 2: HIV+ Participants with Solicited AEs [ Time Frame: 28 days ]
    Numbers and percentages (with 95% CIs) of HIV+ participants with solicited AEs, local and systemic, for 7 days following each vaccination (Days 0 and 21) by severity score, duration, and peak intensity.

  6. Cohort 2: HIV+ Participants with Unsolicited AEs [ Time Frame: 35 days ]
    Numbers and percentages (with 95% CI) of HIV+ participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, MAAEs) through Day 35 by MedDRA classification, severity score, and relatedness.

  7. Cohort 2: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as Geometric Mean Titers (GMTs) [ Time Frame: Day 35 ]
    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs at Day 35.

  8. Cohort 2: Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs) [ Time Frame: Day 35 ]
    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Day 35.

  9. Cohort 2: Serum IgG Antibody Levels Expressed as Seroconversion Rates (SCRs) [ Time Frame: Day 35 ]
    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCR at Day 35. SCR is defined as the percentage of participants with a post-vaccination titer ≥ 4 fold over naïve background and ≥ 2 fold over pre existing titer.


Secondary Outcome Measures :
  1. Cohort 1: HIV- Participants with Individual Strata of Symptomatic Virologically Confirmed, Mild, Moderate, or Severe COVID-19 [ Time Frame: Day 28 to Day 386 ]
    Number of HIV- participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness in terms of individual strata of symptomatic virologically confirmed, mild, moderate, or severe COVID-19.

  2. Cohort 1: HIV- Participants with COVID-19 Requiring Hospitalization [ Time Frame: Day 28 to Day 386 ]
    Number of HIV- participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with COVID-19 requiring hospitalization.

  3. Cohort 1: Incidence, Maximum Severity Score, and Symptom Duration of SARS-CoV-2 Infection by Severity Classification [ Time Frame: Day 28 to Day 386 ]
    Incidence, maximum severity score, and symptom duration of SARS-CoV-2 infection by classification of symptomatic virologically confirmed, mild, moderate, and/or severe disease in HIV- participants.

  4. Cohort 1: Serum IgG Antibody Levels at Multiple Time Points Expressed as GMTs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at Days 0 (baseline), 21 (post first dose), and at 3 and 6 months after the last vaccination in HIV- participants.

  5. Cohort 1: Serum IgG Antibody Levels at Multiple Time Points Expressed as GMFRs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Days 0 (baseline), 21 (post first dose), and at 3 and 6 months after the last vaccination in HIV- participants.

  6. Cohort 1: Serum IgG Antibody Levels at Multiple Time Points Expressed as SCRs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs at Days 0 (baseline), 21 (post first dose), and at 3 and 6 months after the last vaccination in HIV- participants. SCR is defined as the percentage of participants with a post-vaccination titer ≥ 4 fold over naïve background and ≥ 2 fold over pre-existing titer.

  7. Cohort 1: Serum IgG Antibody Levels at Multiple Time Points Expressed as Seroprotection Rates (SPRs) [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen as detected by ELISA expressed as SPRs at Days 0 (baseline), 21 (post first dose), and at 3 and 6 months after the last vaccination in HIV- participants. SPR is defined as the proportion of participants with rises in ELISA units exceeding the 95th percentile of placebo participants who remain COVID-19 free by symptom monitoring.

  8. Cohort 1: Angiotensin-Converting Enzyme 2 (ACE2) Receptor Binding Inhibition Assay Expressed as GMTs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMTs at Days 0 (baseline), 21 (post first dose), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV- participants.

  9. Cohort 1: ACE2 Receptor Binding Inhibition Assay Expressed as GMFRs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMFRs at Days 0 (baseline), 21 (post first dose), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV- participants.

  10. Cohort 1: ACE2 Receptor Binding Inhibition Assay Expressed as SCRs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SCRs at Days 0 (baseline), 21 (post first dose), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV- participants.

  11. Cohort 1: ACE2 Receptor Binding Inhibition Assay Expressed as Seroresponse Rates (SRRs) [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SRRs at Days 0 (baseline), 21 (post first dose), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV- participants. SRR is defined as the proportion of participants with rises in titers exceeding the 95th percentile of placebo participants at the same time point and based on prior SARS-CoV-2 exposure.

  12. Cohort 1: Neutralizing Antibody Activity Expressed as GMTs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Neutralizing antibody activity as detected by microneutralization assay (MN) as expressed as GMTs at Days 0 (baseline), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV- participants.

  13. Cohort 1: Neutralizing Antibody Activity Expressed as GMFRs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Neutralizing antibody activity as detected by MN expressed as GMFRs at Days 0 (baseline), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV-participants.

  14. Cohort 1: Neutralizing Antibody Activity Expressed as SCRs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Neutralizing antibody activity as detected by MN expressed as SCRs (≥ 4 fold change) at Days 0 (baseline), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV- participants.

  15. Cohort 1: Neutralizing Antibody Activity Expressed as SRRs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Neutralizing antibody activity as detected by MN expressed as SRRs at Days 0 (baseline), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV-participants.

  16. Cohort 1: HIV- Participants with Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) [ Time Frame: 386 days ]
    Numbers and percentages (with 95% CI) of participants with MAAEs, AESI, or SAE through End of Study by MedDRA classification, severity score, and relatedness in HIV- participants.

  17. Cohort 2: Serum IgG Antibody Levels at Multiple Time Points Expressed as GMTs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at Days 0 (baseline), 21 (post first dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

  18. Cohort 2: Serum IgG Antibody Levels at Multiple Time Points Expressed as GMFRs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Days 0 (baseline), 21 (post first dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

  19. Cohort 2: Serum IgG Antibody Levels at Multiple Time Points Expressed as SCRs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs at Days 0 (baseline), 21 (post first dose), and at 3 and 6 months after the last vaccination in HIV+ participants. SCR is defined as the percentage of participants with a post-vaccination titer ≥ 4 fold over naïve background and ≥ 2 fold over pre-existing titer.

  20. Cohort 2: Serum IgG Antibody Levels at Multiple Time Points Expressed as SPRs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen as detected by ELISA expressed as SPRs at Days 0 (baseline), 21 (post first dose), and at 3 and 6 months after the last vaccination in HIV+ participants. SPR is defined as the proportion of participants with rises in ELISA units exceeding the 95th percentile of placebo participants who remain COVID-19 free by symptom monitoring.

  21. Cohort 2: ACE2 Receptor Binding Inhibition Assay Expressed as GMTs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMTs at Days 0 (baseline), 21 (post first dose), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

  22. Cohort 2: ACE2 Receptor Binding Inhibition Assay Expressed as GMFRs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMFRs at Days 0 (baseline), 21 (post first dose), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

  23. Cohort 2: ACE2 Receptor Binding Inhibition Assay Expressed as SCRs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SCRs at Days 0 (baseline), 21 (post first dose), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

  24. Cohort 2: ACE2 Receptor Binding Inhibition Assay Expressed as SRRs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SRRs at Days 0 (baseline), 21 (post first dose), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV+ participants. SRR is defined as the proportion of participants with rises in titers exceeding the 95th percentile of placebo participants at the same time point and based on prior SARS-CoV-2 exposure.

  25. Cohort 2: Neutralizing Antibody Activity Expressed as GMTs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Neutralizing antibody activity as detected by MN as expressed as GMTs at Days 0 (baseline), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

  26. Cohort 2: Neutralizing Antibody Activity Expressed as GMFRs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Neutralizing antibody activity as detected by MN expressed as GMFRs at Days 0 (baseline), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

  27. Cohort 2: Neutralizing Antibody Activity Expressed as SCRs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Neutralizing antibody activity as detected by MN expressed as SCRs (≥ 4 fold change) at Days 0 (baseline), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

  28. Cohort 2: Neutralizing Antibody Activity Expressed as SRRs [ Time Frame: Day 0 to 6 months after the last vaccination ]
    Neutralizing antibody activity as detected by MN expressed as SRRs at Days 0 (baseline), 35 (post second dose), and at 3 and 6 months after the last vaccination in HIV+ participants.

  29. Cohort 2: HIV+ Participants with MAAEs, AESIs, and SAEs [ Time Frame: 386 days ]
    Numbers and percentages (with 95% CI) of participants with MAAEs, AESI, or SAE through End of Study by MedDRA classification, severity score, and relatedness in HIV+ participants.

  30. Cohort 2: HIV+ Participants with Symptomatic Virologically Confirmed, Mild, Moderate, or Severe COVID-19 [ Time Frame: Day 28 to Day 385 ]
    Counts and proportions of symptomatic virologically confirmed, mild, moderate, and severe COVID-19 outcomes in HIV+ participants as previously described in the second primary efficacy endpoint for Cohort 1 (HIV- participants).

  31. Cohort 2: Incidence, Maximum Severity Score, and Symptom Duration of SARS-CoV-2 Infection by Severity Classification [ Time Frame: Day 28 to Day 385 ]
    Incidence, maximum severity score, and symptom duration of SARS-CoV-2 infection by classification of symptomatic virologically confirmed, mild, moderate, and/or severe disease in HIV+ participants.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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, 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:

    1. hypertension uncontrolled for age;
    2. congestive heart failure;
    3. chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbation of any severity in the past 2 years;
    4. evidence of unstable coronary artery disease in the past 3 months, as determined by the investigator;
    5. asthma;
    6. Type 2 diabetes (adult onset) requiring treatment with insulin;
    7. chronic kidney disease/renal insufficiency;
    8. Chronic gastrointestinal and hepatic diseases;
    9. 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 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).
  • 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 > 38°C 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04533399


Contacts
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Contact: Rani Naidoo +27 (011) 6566167 premadevi.naidoo@ppdi.com

Locations
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South Africa
ZA018 Not yet recruiting
Bloemfontein, Free State Of South Africa, South Africa
ZA003 Not yet recruiting
Hillbrow, Gauteng, South Africa
Site ZA001 Recruiting
Johannesburg, Gauteng, South Africa
ZA012 Not yet recruiting
Johannesburg, Gauteng, South Africa
Site ZA015 Not yet recruiting
Pretoria, Gauteng, South Africa
ZA019 Not yet recruiting
Durban, KwaZulu-Natal, South Africa
ZA020 Not yet recruiting
Durban, KwaZulu-Natal, South Africa
ZA013 Not yet recruiting
Cape Town, Western Cape, South Africa
ZA014 Not yet recruiting
Worcester, Western Cape, South Africa
Sponsors and Collaborators
Novavax
Investigators
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Study Director: Vivek Shinde, MD, MPH Novavax, Inc.
Principal Investigator: Shabir A Madhi, MBBCH, PhD University of Witwatersrand, South Africa
Additional Information:
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Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT04533399    
Other Study ID Numbers: 2019nCoV-501
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Novavax:
Coronavirus