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AzTrials

SARS-CoV-2 InfectionPhase 2NCT04533399

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

A Phase 2 study testing SARS-CoV-2 rS/Matrix-M1 Adjuvant in people with SARS-CoV-2 Infection and COVID-19, run by Novavax at 14 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 84 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2 Infection, COVID-19
What is being tested?
SARS-CoV-2 rS/Matrix-M1 Adjuvant
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,422 participants
Where
14 sitesSouth Africa
Study dates
17 Aug 2020to 19 Jan 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 84 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All subjects:
  • Adult male and female aged ≥ 18 to < 65 years at screening for Cohorts 1 and 2 and Adult male or female aged ≥ 65 to < 85 years at screening for Cohort 1 only.
  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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 > 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

South Africa14 sites

  • ZA018

    Bloemfontein, Free State of South Africa

  • ZA013

    Cape Town, Western Cape

  • ZA019

    Durban, KwaZulu-Natal

  • ZA020

    Durban, KwaZulu-Natal

  • ZA021

    Durban, KwaZulu-Natal

  • ZA024

    Durban, KwaZulu-Natal

  • ZA003

    Hillbrow, Gauteng

  • Site ZA001

    Johannesburg, Gauteng

  • ZA012

    Johannesburg, Gauteng

  • ZA022

    Madibeng, North West

  • Site ZA015

    Pretoria, Gauteng

  • ZA023

    Pretoria, Gauteng

  • ZA007

    Thabazimbi, Limpopo

  • ZA014

    Worcester, Western Cape

Other trials in South Africa

About this study

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

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.

Being tested
SARS-CoV-2 rS/Matrix-M1 Adjuvant, Placebo
Keywords
Coronavirus
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARS-CoV-2 rS/Matrix-M1 AdjuvantBiological

    Also called NVX-CoV2373

    Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21.

  • PlaceboOther

    Also called Sodium chloride 0.9% (BP, sterile)

    Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21.

Study groups in NCT04533399
Study groupRoleWhat they receive
Cohort 1 (HIV negative) 5 μg SARS-CoV-2 rS/Matrix-M1 AdjuvantExperimental2 doses of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21.
Receives: Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant
Cohort 1 (HIV negative) PlaceboPlacebo comparator2 doses of Placebo (Saline), 1 dose each on Days 0 and 21.
Receives: Other: Placebo
Cohort 2 (HIV positive) 5 μg SARS-CoV-2 rS/Matrix-M1 AdjuvantExperimental2 doses of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21.
Receives: Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant
Cohort 2 (HIV positive) PlaceboPlacebo comparator2 doses of Placebo (Saline), 1 dose each on Days 0 and 21.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort 1: HIV- Participants with Symptomatic Mild, Moderate, or Severe COVID-19

    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.

    Measured: Day 28 to Day 386

  2. Cohort 2: HIV + Participants with Symptomatic Mild, Moderate, or Severe COVID-19

    Number of HIV+ participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with symptomatic mild,moderate or severe COVID-19 assessed from Day 28 (7 days after second vaccination) through the length of the study.

    Measured: Day 28 to Day 386

  3. Cohort 1: HIV- Participants with Solicited Adverse Events (AEs)

    Number 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.

    Measured: 28 days

  4. Cohort 1: HIV- Participants with Unsolicited AEs

    Number 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.

    Measured: 35 days

  5. Cohort 2: HIV+ Participants with Solicited AEs

    Number 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.

    Measured: 28 days

  6. Cohort 2: HIV+ Participants with Unsolicited AEs

    Number 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.

    Measured: 35 days

  7. Cohort 2: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as Geometric Mean Titers (GMTs)

    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.

    Measured: Day 35

  8. Cohort 2: Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs)

    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Day 35.

    Measured: Day 35

  9. Cohort 2: Serum IgG Antibody Levels Expressed as Seroconversion Rates (SCRs)

    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.

    Measured: Day 35

  10. Healthcare Worker Expansion (Cohort 3): Participants with AESI's

    Number of healthy adult HCW, with AESIs for 14 days post second vaccination (Day 35) by severity score, duration, and peak intensity.

    Measured: Day 35

  11. Healthcare Worker Expansion (Cohort 4): Participants with AESI's

    Number of healthy adult HCW, with AESIs for 14 days post second vaccination (Day 70) by severity score, duration, and peak intensity.

    Measured: Day 70

Secondary outcomes (39)

  1. Cohort 1: HIV- Participants with Individual Strata of Symptomatic Virologically Confirmed, Mild, Moderate, or Severe COVID-19

    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.

    Measured: Day 28 to Day 386

  2. Cohort 1: HIV- Participants with COVID-19 Requiring Hospitalization

    Number of HIV- participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with COVID-19 requiring hospitalization.

    Measured: Day 28 to Day 386

  3. Cohort 1: Incidence, Maximum Severity Score, and Symptom Duration of SARS-CoV-2 Infection by Severity Classification

    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.

    Measured: Day 28 to Day 386

  4. Cohort 1: Serum IgG Antibody Levels at Multiple Time Points Expressed as GMTs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  5. Cohort 1: Serum IgG Antibody Levels at Multiple Time Points Expressed as GMFRs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  6. Cohort 1: Serum IgG Antibody Levels at Multiple Time Points Expressed as SCRs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  7. Cohort 1: Angiotensin-Converting Enzyme 2 (ACE2) Receptor Binding Inhibition Assay Expressed as GMTs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  8. Cohort 1: ACE2 Receptor Binding Inhibition Assay Expressed as GMFRs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  9. Cohort 1: ACE2 Receptor Binding Inhibition Assay Expressed as SCRs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  10. Cohort 1: ACE2 Receptor Binding Inhibition Assay Expressed as Seroresponse Rates (SRRs)

    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.

    Measured: Day 0 to 6 months after the last vaccination

  11. Cohort 1: Neutralizing Antibody Activity Expressed as GMTs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  12. Cohort 1: Neutralizing Antibody Activity Expressed as GMFRs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  13. Cohort 1: Neutralizing Antibody Activity Expressed as SCRs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  14. Cohort 1: Neutralizing Antibody Activity Expressed as SRRs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  15. Cohort 1: HIV- Participants with Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)

    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.

    Measured: 386 days

  16. Cohort 2: Serum IgG Antibody Levels at Multiple Time Points Expressed as GMTs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  17. Cohort 2: Serum IgG Antibody Levels at Multiple Time Points Expressed as GMFRs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  18. Cohort 2: Serum IgG Antibody Levels at Multiple Time Points Expressed as SCRs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  19. Cohort 2: ACE2 Receptor Binding Inhibition Assay Expressed as GMTs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  20. Cohort 2: ACE2 Receptor Binding Inhibition Assay Expressed as GMFRs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  21. Cohort 2: ACE2 Receptor Binding Inhibition Assay Expressed as SCRs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  22. Cohort 2: ACE2 Receptor Binding Inhibition Assay Expressed as SRRs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  23. Cohort 2: Neutralizing Antibody Activity Expressed as GMTs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  24. Cohort 2: Neutralizing Antibody Activity Expressed as GMFRs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  25. Cohort 2: Neutralizing Antibody Activity Expressed as SCRs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  26. Cohort 2: Neutralizing Antibody Activity Expressed as SRRs

    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.

    Measured: Day 0 to 6 months after the last vaccination

  27. Cohort 2: HIV+ Participants with MAAEs, AESIs, and SAEs

    Number of participants with MAAEs, AESI, or SAE through End of Study by MedDRA classification, severity score, and relatedness in HIV+ participants.

    Measured: 386 days

  28. Cohort 2: HIV+ Participants with Symptomatic Virologically Confirmed, Mild, Moderate, or Severe COVID-19

    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).

    Measured: Day 28 to Day 385

  29. Cohort 2: Incidence, Maximum Severity Score, and Symptom Duration of SARS-CoV-2 Infection by Severity Classification

    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.

    Measured: Day 28 to Day 385

  30. Cohort 1: HIV- Participants with Asymptomatic, Symptomatic Mild, Moderate, or Severe COVID-19

    Number of HIV- participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with asymptomatic, symptomatic mild, moderate or severe COVID-19 assessed from 7 days after the second vaccine dose (eg, Day 28)

    Measured: Day 28

  31. Cohort 2: HIV+ Participants with Asymptomatic, Symptomatic Mild, Moderate, or Severe COVID-19

    Number of HIV+ participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with asymptomatic, symptomatic mild, moderate or severe COVID-19 assessed from 7 days after the second vaccine dose (eg, Day 28)

    Measured: Day 28

  32. Healthcare Worker Expansion (Cohort 3): Serum IgG Antibody Expressed as GMT

    Serum IgG antibody levels specific for the SARS CoV 2 rS protein antigen(s) as detected by ELISA using GMTs at 14 days post second vaccination (Day 35 for Cohort 3) in adult HCW.

    Measured: Day 35

  33. Healthcare Worker Expansion (Cohort 3): Serum IgG Antibody Expressed as GMEU

    Serum IgG antibody levels specific for the SARS CoV 2 rS protein antigen(s) as detected by ELISA expressed as GMEU at 14 days post second vaccination (Day 35 for Cohort 3) in adult HCW.

    Measured: Day 35

  34. Healthcare Worker Expansion (Cohort 3): Serum IgG Antibody Expressed as GMFR

    Serum IgG antibody levels specific for the SARS CoV 2 rS protein antigen(s) as detected by ELISA expressed as GMFR at 14 days post second vaccination (Day 35 for Cohort 3) in adult HCW.

    Measured: Day 35

  35. Healthcare Worker Expansion (Cohort 3): Serum IgG Antibody Expressed as SCR

    Serum IgG antibody levels specific for the SARS CoV 2 rS protein antigen(s) as detected by ELISA expressed as SCR at 14 days post second vaccination (Day 35 for Cohort 3) in adult HCW.

    Measured: Day 35

  36. Healthcare Worker Expansion (Cohort 4): Serum IgG Antibody Expressed as GMT

    Serum IgG antibody levels specific for the SARS CoV 2 rS protein antigen(s) as detected by ELISA expressed as GMT at 14 days post second vaccination (Day 70 for Cohort 4) in adult HCW.

    Measured: Day 70

  37. Healthcare Worker Expansion (Cohort 4): Serum IgG Antibody Expressed as GMEU

    Serum IgG antibody levels specific for the SARS CoV 2 rS protein antigen(s) as detected by ELISA expressed as GMEU at 14 days post second vaccination (Day 70 for Cohort 4) in adult HCW.

    Measured: Day 70

  38. Healthcare Worker Expansion (Cohort 4): Serum IgG Antibody Expressed as GMFR

    Serum IgG antibody levels specific for the SARS CoV 2 rS protein antigen(s) as detected by ELISA expressed as GMFR at 14 days post second vaccination (Day 70 for Cohort 4) in adult HCW.

    Measured: Day 70

  39. Healthcare Worker Expansion (Cohort 4): Serum IgG Antibody Expressed as SCR

    Serum IgG antibody levels specific for the SARS CoV 2 rS protein antigen(s) as detected by ELISA expressed as SCR at 14 days post second vaccination (Day 70 for Cohort 4) in adult HCW.

    Measured: Day 70

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2020
  2. Study start17 Aug 2020
  3. Primary completion7 Dec 2021
  4. Study completion19 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,422 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04533399
Sponsor's protocol ID
2019nCoV-501
Status last verified
Feb 2022
First submitted
28 Aug 2020
Last updated
17 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Madhi SA, Moodley D, Hanley S, Archary M, Hoosain Z, Lalloo U, Louw C, Fairlie L, Fouche LF, Masilela MSL, Singh N, Grobbelaar C, Ahmed K, Benade G, Bhikha S, Bhorat AE, Bhorat Q, Joseph N, Dheda K, Esmail A, Foulkes S, Goga A, Oommen Jose A, Kruger G, Kalonji DJ, Lalloo N, Lombaard JJ, Lombard Koen A, Kany Luabeya A, Mngqibisa R, Petrick FG, Pitsi A, Tameris M, Thombrayil A, Vollgraaff PL, Cloney-Clark S, Zhu M, Bennett C, Albert G, Faust E, Plested JS, Fries L, Robertson A, Neal S, Cho I, Glenn GM, Shinde V; 2019nCoV-501 Study Group. Immunogenicity and safety of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine in people living with and without HIV-1 infection: a randomised, controlled, phase 2A/2B trial. Lancet HIV. 2022 May;9(5):e309-e322. doi: 10.1016/S2352-3018(22)00041-8.

    PubMed 35489376

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Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SARS-CoV-2 rS/Matrix-M1 Adjuvant in people with SARS-CoV-2 Infection and COVID-19, run by Novavax at 14 sites in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: HIV- Participants with Symptomatic Mild, Moderate, or Severe COVID-19 (time frame: Day 28 to Day 386). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04533399, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.

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