Changes to trial information |
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Trial Information |
Official scientific title |
26/08/2020 |
Term COVID-19 added as per WHO request for ease of record identification |
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 |
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. COVID-19 |
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Reporting |
IPD description |
04/09/2020 |
Information not previously provided. |
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At a minimum, summary results or a link to summary results will be provided within the trial registration record. |
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Reporting |
IPD-Sharing time frame |
04/09/2020 |
Information not previously provided. |
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This will be done within 12 months of the study completion date. |
Section Name
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Field Name
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Date
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Reporting |
Key access criteria |
04/09/2020 |
Information not previously provided. |
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Based on the data sharing agreement with the funder, which is in progress |
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Field Name
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Date
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Reporting |
IPD URL |
04/09/2020 |
Information not previously provided. |
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Not available at present |
Section Name
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Date
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Reporting |
Study protocol document |
04/09/2020 |
Information not previously provided. |
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Study Protocol, Clinical Study Report |
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Reporting |
Results Available |
04/09/2020 |
Information not previously provided. |
No |
No |
Section Name
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Field Name
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Date
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Reason
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Intervention |
Intervention List |
14/10/2020 |
Increase in the total sample size of the study from 2,904 to a minimum of approximately 3,200 to a maximum of approximately 4,404 subjects |
Experimental Group, Cohort 1 HIV negative, SARS-CoV-2 rS 5 μg 5 μg, administered by intramuscular injection on Day 0 and Day 21, ideally in alternating deltoids., Single injection, Biological/Vaccine: SARS-CoV-2 rS 5 μg. Other Names: severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine.
Biological/Vaccine: Matrix-M1 50 μg, administered with SARS-CoV-2 rS. Other Names: Adjuvant., 1332, |
Experimental Group, Cohort 1 HIV negative, SARS-CoV-2 rS 5 μg 5 μg, administered by intramuscular injection on Day 0 and Day 21, ideally in alternating deltoids., Single injection, Biological/Vaccine: SARS-CoV-2 rS 5 μg. Other Names: severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine.
Biological/Vaccine: Matrix-M1 50 μg, administered with SARS-CoV-2 rS. Other Names: Adjuvant., 2082, |
Section Name
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Field Name
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Date
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Reason
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Intervention |
Intervention List |
14/10/2020 |
Increase in the total sample size of the study from 2,904 to a minimum of approximately 3,200 to a maximum of approximately 4,404 subjects |
Control Group, Cohort 1 HIV negative, Placebo Administered by intramuscular injection on Day 0 and Day 21, Single Injection, Placebo: Sodium chloride 0.9% (BP, sterile) , 1332, Placebo |
Control Group, Cohort 1 HIV negative, Placebo Administered by intramuscular injection on Day 0 and Day 21, Single Injection, Placebo: Sodium chloride 0.9% (BP, sterile) , 2082, Placebo |
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Eligibility |
Age group |
14/10/2020 |
Increase in the upper limit of the eligible age to < 85 years in Cohort 1 only, with an effort to enroll a target of 10 25% of subjects ≥ 65 to <85 years of age. RATIONALE: older adults represent an important risk group to be prioritized in the early rollout of COVID-19 vaccine deployment globally because this population is at increased risk serious COVID-19 outcomes |
Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) |
Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year |
Section Name
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Field Name
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Eligibility |
Maximum age |
14/10/2020 |
Increase in the upper limit of the eligible age to < 85 years in Cohort 1 only, with an effort to enroll a target of 10 25% of subjects ≥ 65 to <85 years of age. RATIONALE: older adults represent an important risk group to be prioritized in the early rollout of COVID-19 vaccine deployment globally because this population is at increased risk serious COVID-19 outcomes |
64 Year(s) |
85 Year(s) |
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Eligibility |
Exclusion criteria |
14/10/2020 |
Exclusion Criteria (Section 4.2) were broadened or clarified as follows:
o Broaden the eligibility criteria by providing the actual blood pressure values that define hypertension according to the South African Hypertension Society Practice Guidelines (Exclusion Criterion 2a). This exclusion criterion now references local South African Hypertension Society Guidelines and allow for mild Grade 1 hypertension.
o Broaden the eligibility criteria by defining congestive heart failure (Exclusion Criterion 2b). Mild congestive heart failure without history of exacerbation in the prior 2 years is now allowed.
o Clarify that stable coronary heart disease was not exclusionary (Exclusion Criterion 2d).
o Broaden the eligibility criteria by defining asthma (Exclusion Criterion 2e). Mild, intermittent asthma not requiring chronic control medication is now allowed.
o Add type 1 diabetes to the exclusion criteria since type 1 diabetes subjects require insulin and clarified that non-insulin dependent type 2 diabetes subjects were not exclusionary (Exclusion Criterion 2f).
o Clarify chronic neurological diseases (Exclusion Criterion 2i).
o Added that the use of inhaled glucocorticoids was permitted (Exclusion Criterion 8).
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• Any current acute illness requiring medical or surgical care, or chronic illness (excluding HIV in HIV-positive subjects) that requires changes in medication in the past 2 months indicating that chronic illness/disease is not stable.
• Chronic disease, including:
a. hypertension uncontrolled for age;
b. congestive heart failure;
c. chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbation of any severity in the past 2 years;
d. evidence of unstable coronary artery disease in the past 3 months, as determined by the investigator;
e. asthma;
f. Type 2 diabetes (adult onset) requiring treatment with insulin;
g. chronic kidney disease/renal insufficiency;
h. Chronic gastrointestinal and hepatic diseases;
i. chronic neurological diseases (such as multiple sclerosis, dementia, transient ischemic attacks, Parkinson's disease, degenerative neurological conditions, neuropathy, epilepsy, or a history of stroke or previous neurological disorder within the past 12 months with residual symptoms). Subjects with a history of migraine or chronic headaches, or nerve root compression that have been stable on treatment for the last 4 weeks are not excluded.
• Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination.
• Prior receipt of investigational or approved COVID-19 vaccine at any time.
• History of a diagnosis of suspected or confirmed COVID-19.
• Received influenza (flu) vaccination within 14 days prior to first study vaccination; or any other vaccine within 4 weeks prior to first study vaccination; or planned vaccination with 5 weeks after first 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 drug
• Received immunoglobulin, blood-derived products, or other immunosuppressan |
• Any current acute illness requiring medical or surgical care, or chronic illness (excluding HIV in HIV-positive subjects) that requires changes in medication in the past 2 months indicating that chronic illness/disease is not stable.
• Chronic disease, including:
a. hypertension (elevated blood pressure [BP]) ≥ grade 2 (systolic BP ≥ 160 mmHg; and/or diastolic BP ≥ 100 mmHg) according to the South African Hypertension Society’s Practice Guidelines;
b. congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years;
c. chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbation of any severity in the past 2 years. Stable coronary heart disease is NOT exclusionary;
d. evidence of unstable coronary artery disease in the past 3 months, as determined by the investigator;
e. asthma requiring regular/chronic control medication;
f. Type 1 and 2 diabetes (adult onset) requiring treatment with insulin;
g. chronic kidney disease/renal insufficiency;
h. Chronic gastrointestinal and hepatic diseases;
i. chronic neurological diseases (such as multiple sclerosis, dementia, transient ischemic attacks, Parkinson's disease, degenerative neurological conditions, neuropathy, epilepsy, or a history of stroke or previous neurological disorder within the past 12 months with residual symptoms). Subjects with a history of migraine or chronic headaches, or nerve root compression that have been stable on treatment for the last 4 weeks are not excluded.
• Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination.
• Prior receipt of investigational or approved COVID-19 vaccine at any time.
• History of a diagnosis of suspected or confirmed COVID-19.
• Received influenza (flu) vaccination within 14 days prior to first study vaccination; or any other vaccine within 4 weeks prior to first study vaccination; or planned vaccination with 5 weeks after first st |
Section Name
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Field Name
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Date
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Updated Value
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Recruitment Centre |
RecruitmentCentre List |
14/10/2020 |
To achieve increased subject numbers |
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Josha Research, 28 East Burger Street, Bloemfontein, 9300, South Africa |
Section Name
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Date
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Reason
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Recruitment Centre |
RecruitmentCentre List |
14/10/2020 |
To achieve recruitment of increased subject numbers |
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Umlazi Clinical Research Site, Mangosuthu Highway, Umlazi, 4066, South Africa |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Recruitment Centre |
RecruitmentCentre List |
14/10/2020 |
To achieve recruitment of increased subject numbers |
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Verulam Clinical Research Site South African Medical Research Council HIV Prevention Research Unit, 31-33 Wick Street, Verulam, 4340, South Africa |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Recruitment Centre |
RecruitmentCentre List |
14/10/2020 |
To achieve recruitment of increased subject numbers |
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KwaPhila Health Solution, 26 Charles Strachan Road, Durban, 4091, South Africa |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Recruitment Centre |
RecruitmentCentre List |
14/10/2020 |
To enable recruitment of increased subject numbers |
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Durban International Clinical Research Site Enhancing Care Foundation, Umbilo Road, Durban, 4013, South Africa |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Recruitment Centre |
RecruitmentCentre List |
14/10/2020 |
To enable recruitment of increased subject numbers |
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The Aurum Institute Pretoria Clinical Research Centre, 6 Mark Shuttleworth Street, Pretoria, 0087, South Africa |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Recruitment Centre |
RecruitmentCentre List |
14/10/2020 |
To enable recruitment of increased subject numbers |
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Madibeng Centre for Research, 40 Pienaar Street, Brits, , South Africa |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Recruitment Centre |
RecruitmentCentre List |
14/10/2020 |
To enable recruitment of increased subject numbers |
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Limpopo Clinical Research Initiative, 11 Van der Bijl street , Thabazimbi, 0380, South Africa |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Ethics |
Ethics List |
14/10/2020 |
Initial approval for UCT site |
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TRUE, University of Cape Town Faculty of Health Sciences Human Research Ethics Committee , Groote Schuur Hospital, Cape Town, 7925, South Africa, , 01 Oct 2020, 0214066626, hrec-enquiries@uct.ac.za, 12319_12775_4737.pdf |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Ethics |
Ethics List |
14/10/2020 |
Initial approval for UCT site |
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TRUE, University of Cape Town Faculty of Health Sciences Human Research ethics Committee, Groote Schuur Hospital, Cape Town, 7925, South Africa, , 28 Sep 2020, +27214066626, hrec-enquiries@uct.ac.za, 12319_12776_4737.pdf |
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Ethics |
Ethics List |
15/10/2020 |
Approval of Protocol amendment. Version 3.0/Amendment 2 dated 09 September 2020 |
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TRUE, University of the Witwatersrand Human Research Ethics Committee, 31 Princess of Wales Terrace, Johannesburg, 2193, South Africa, , 05 Oct 2020, +27112749200, jennifer.palmer@witshealth.co.za, 12319_12778_4737.pdf |
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Trial Information |
Target no of participants |
01/12/2020 |
Increase in the total sample size of the study from 2,904 to a minimum of approximately 3,200 to a maximum of approximately 4404 subjects. All additional subjects will be added to Cohort 1 (HIV-negative subjects). RATIONALE: the increase in sample size will allow a more rapid accumulation of efficacy endpoints to help accelerate the timing of the endpoint-driven efficacy analysis (and in turn accelerate vaccine development), and to account for the declining intensity of the COVID-19 epidemic in South Africa. |
2904 |
4040 |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Recruitment Centre |
RecruitmentCentre List |
01/12/2020 |
Additional investigator site to meet enrollment numbers |
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The Aurum Institute Pretoria Clinical Research Centre, 6 Mark Shuttleworth Street, Pretoria, 0087, South Africa |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Recruitment Centre |
RecruitmentCentre List |
01/12/2020 |
Additional investigator site to meet enrollment numbers |
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Peermed CTC Merk Kempton, Cnr Voortrekker and Monument Rd, Kempton Park, 1619, South Africa |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Recruitment Centre |
RecruitmentCentre List |
01/12/2020 |
Duplicate |
The Aurum Institute Pretoria Clinical Research Centre, 6 Mark Shuttleworth Street, Pretoria, 0087, South Africa |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Recruitment Centre |
RecruitmentCentre List |
01/12/2020 |
To meet target recruitment numbers |
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Mzansi Ethical Research Centre, 184 Cowen Ntuli street, Middelburg, 1055, South Africa |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Target no of participants |
01/12/2020 |
Increase in the total sample size of the study from 2,904 to a minimum of approximately 3,200 to a maximum of approximately 4404 subjects. All additional subjects will be added to Cohort 1 (HIV-negative subjects). RATIONALE: the increase in sample size will allow a more rapid accumulation of efficacy endpoints to help accelerate the timing of the endpoint-driven efficacy analysis (and in turn accelerate vaccine development), and to account for the declining intensity of the COVID-19 epidemic in South Africa. |
4040 |
4404 |