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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (HIV negative) 5 μg SARS-CoV-2 rS/Matrix-M1 Adjuvant | Experimental | 2 doses of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21. |
|
| Cohort 1 (HIV negative) Placebo | Placebo Comparator | 2 doses of Placebo (Saline), 1 dose each on Days 0 and 21. |
|
| Cohort 2 (HIV positive) 5 μg SARS-CoV-2 rS/Matrix-M1 Adjuvant | Experimental | 2 doses of SARS-CoV-2 rS - 5 μg + 50 μg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21. |
|
| Cohort 2 (HIV positive) Placebo | Placebo Comparator | 2 doses of Placebo (Saline), 1 dose each on Days 0 and 21. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 rS/Matrix-M1 Adjuvant | Biological | Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 to Day 386 |
| 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. | Day 28 to Day 386 |
| 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. | 28 days |
| 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. | 35 days |
| 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. | 28 days |
| Cohort 2: HIV+ Participants with Unsolicited AEs |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 to Day 386 |
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Inclusion Criteria:
All subjects:
HIV-negative subjects only:
HIV-positive subjects only:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development | Novavax, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZA018 | Bloemfontein | Free State of South Africa | South Africa | |||
| ZA003 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35489376 | Derived | 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. | |
| 33951374 |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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|
| Placebo | Other | Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21. |
|
|
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. |
| 35 days |
| 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. | Day 35 |
| 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. | Day 35 |
| 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. | Day 35 |
| 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. | Day 35 |
| 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. | Day 70 |
| 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. |
| Day 28 to Day 386 |
| 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. | Day 28 to Day 386 |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | 386 days |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | Day 0 to 6 months after the last vaccination |
| 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. | 386 days |
| 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). | Day 28 to Day 385 |
| 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. | Day 28 to Day 385 |
| 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) | Day 28 |
| 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) | Day 28 |
| 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. | Day 35 |
| 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. | Day 35 |
| 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. | Day 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. | Day 35 |
| 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. | Day 70 |
| 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. | Day 70 |
| 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. | Day 70 |
| 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. | Day 70 |
| Hillbrow |
| Gauteng |
| South Africa |
| Site ZA001 | Johannesburg | Gauteng | South Africa |
| ZA012 | Johannesburg | Gauteng | South Africa |
| Site ZA015 | Pretoria | Gauteng | South Africa |
| ZA023 | Pretoria | Gauteng | South Africa |
| ZA019 | Durban | KwaZulu-Natal | South Africa |
| ZA020 | Durban | KwaZulu-Natal | South Africa |
| ZA021 | Durban | KwaZulu-Natal | South Africa |
| ZA024 | Durban | KwaZulu-Natal | South Africa |
| ZA007 | Thabazimbi | Limpopo | South Africa |
| ZA022 | Madibeng | North West | South Africa |
| ZA013 | Cape Town | Western Cape | South Africa |
| ZA014 | Worcester | Western Cape | South Africa |
| Derived |
| Shinde V, Bhikha S, Hoosain Z, Archary M, Bhorat Q, Fairlie L, Lalloo U, Masilela MSL, Moodley D, Hanley S, Fouche L, Louw C, Tameris M, Singh N, Goga A, Dheda K, Grobbelaar C, Kruger G, Carrim-Ganey N, Baillie V, de Oliveira T, Lombard Koen A, Lombaard JJ, Mngqibisa R, Bhorat AE, Benade G, Lalloo N, Pitsi A, Vollgraaff PL, Luabeya A, Esmail A, Petrick FG, Oommen-Jose A, Foulkes S, Ahmed K, Thombrayil A, Fries L, Cloney-Clark S, Zhu M, Bennett C, Albert G, Faust E, Plested JS, Robertson A, Neal S, Cho I, Glenn GM, Dubovsky F, Madhi SA; 2019nCoV-501 Study Group. Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant. N Engl J Med. 2021 May 20;384(20):1899-1909. doi: 10.1056/NEJMoa2103055. Epub 2021 May 5. |
| CDC (Centers for Disease Control and Prevention): Coronavirus (COVID-19) website | View source |
| WHO COVID-19 treatment guidelines | View source |
| WHO South Africa website | View source |
| COVID-19 Corona Virus - Department of Health, Republic of South Africa | View source |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 27, 2023 | Apr 21, 2023 | 5 | ||
| Jun 5, 2023 | Jul 3, 2023 | 6 | ||
| Aug 22, 2023 | Sep 20, 2023 | 7 | ||
| Feb 13, 2025 | Mar 6, 2025 | 8 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000711928 | NVX-CoV2373 adjuvated lipid nanoparticle |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided