Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 221698/Z/20/Z | Other Grant/Funding Number | Wellcome Trust |
Not provided
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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
Not provided
Not provided
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The purpose of this study is to assess the safety and immunogenicity of M72/AS01E vaccination in virally suppressed, antiretroviral-treated participants with human immunodeficiency virus infection (HIV).
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M72/AS01E vaccine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M72/AS01E Mycobacterium tuberculosis vaccine | Biological | Participants will receive an intramuscular dose of M72 (10 micrograms of recombinant fusion protein) reconstituted with AS01E (an adjuvant system), on Day 1 and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Adverse Events (AEs) Through 7 Days Post Dose 1 of Study Intervention | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE does not necessarily have a causal relationship with the intervention. Solicited AEs were defined events that participants were specifically asked about and which were noted by participants in the diary card. Solicited local AEs included pain, redness and swelling and general body symptoms such as fever, headache, fatigue, gastrointestinal symptoms, and myalgia. | Day 1 through Day 7 (after first vaccination) |
| Number of Participants With Solicited AEs Through 7 Days Post Dose 2 of Study Intervention | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE does not necessarily have a causal relationship with the intervention. Solicited AEs were defined events that participants were specifically asked about and which were noted by participants in the diary card. Solicited local AEs included pain, redness and swelling and general body symptoms such as fever, headache, fatigue, gastrointestinal symptoms, and myalgia. | Day 29 through Day 35 (after second vaccination) |
| Number of Participants With Unsolicited AEs Through 28 Days Post Dose 1 of Study Intervention | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE does not necessarily have a causal relationship with the intervention. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary card. Number of Participants With Unsolicited AEs Through 28 Days after first vaccination has been presented. | Day 1 through Day 28 |
| Number of Participants With Unsolicited AEs Through 28 Days Post Dose 2 of Study Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Potential Immune-mediated Diseases (pIMDs) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. pIMDs are a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Number of Participants With Potential Immune-mediated Diseases (pIMDs) has been presented |
Not provided
Inclusion Criteria:
Participant with documented human immunodeficiency virus (HIV) infection who fulfill all of the following:
Participants have had tuberculosis (TB) preventive therapy (TPT) in the past and are not receiving TPT at the time of screening, according to the judgment of the investigators
Participants who are healthy as determined by medical evaluation including medical history, physical examination and laboratory tests
Capable of giving signed informed consent and informed assent (if appropriate), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) or informed assent form, and in the protocol.
Female participants of childbearing potential must agree not to become pregnant from the time of study enrollment for one year after study intervention. Women physically capable of pregnancy, sexually active and having no history of hysterectomy or tubal ligation or menopause must agree to use an effective method of avoiding pregnancy during this period.
Participants who agree to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and have no current plans to relocate from the study area for the duration of the study.
Exclusion Criteria:
Acute illness or fever ≥99.5°F (or ≥37.5˚C) on Day 1
History of active TB disease
Evidence of active TB disease with any of the following:
Evidence and/or history of clinically significant medical conditions (other than HIV infection) as judged by the investigator, including malignancies
Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the participant will comply with the protocol
Any medications or other therapies that may impact the immune system such as immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with major organ toxicity as determined by the investigator, within 90 days prior to Day 1
Immunosuppressive agents including systemic steroids - prior corticosteroid therapy within 90 days prior to Day 1 (permitted: 5 mg/day prednisone equivalent, inhaled, topical, and intra-articular corticosteroids)
Receipt or donation of blood or blood products within 90 days prior to Day 1 or planned receipt or donation during the study period
Participation in an interventional clinical trial and/or receipt of any investigational drug within 180 days prior to signing informed consent or assent
Receipt of any vaccine in the period starting 7 days before, and ending 7 days after, each dose of the study vaccine
History of previous administration of experimental Mycobacterium tuberculosis vaccine
Safety laboratory values outside of normal range, for age and sex that are suggestive of a disease state (Grade 1 abnormalities, as per Division of AIDS [DAIDS] toxicity table version 2.1, will not lead to exclusion if the investigator considers them not clinically significant.)
Urinalysis abnormality greater than Grade 1 on the Toxicity Scale (with the exception of hematuria in a menstruating female), or urinalysis abnormality judged clinically significant by the investigator
Current hepatitis B and/or hepatitis C infection
Indeterminate QFT result
History of allergy or hypersensitivity to the study drug, excipients or related substances
Shared residence with an individual who is receiving TB treatment or with someone who is known to have incompletely treated TB, e.g., Xpert MTB/RIF assay-positive, polymerase chain reaction (PCR)-positive, culture-positive, smear-positive TB, or clinically diagnosed unconfirmed TB
Female participants with any one of the following conditions: currently pregnant or lactating/nursing; having positive serum pregnancy test during the screening window, planning a pregnancy within 1 year after first dose of study product
Individuals who are acting as study personnel or immediate family members (brother, sister, child, parent) or the spouse/partner of study personnel.
Child in Care
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| Name | Affiliation | Role |
|---|---|---|
| Gates MRI | Gates Medical Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wits RHI | Johannesburg | Gauteng | 2001 | South Africa | ||
| Ekhaya VAC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40614747 | Derived | Dagnew AF, Han LL, Naidoo K, Fairlie L, Innes JC, Middelkoop K, Tameris M, Wilkinson RJ, Ananworanich J, Bower D, Schlehuber L, Frahm N, Cinar A, Dunne M, Schmidt AC. Safety and immunogenicity of investigational tuberculosis vaccine M72/AS01E-4 in people living with HIV in South Africa: an observer-blinded, randomised, controlled, phase 2 trial. Lancet HIV. 2025 Aug;12(8):e546-e555. doi: 10.1016/S2352-3018(25)00124-9. Epub 2025 Jul 1. |
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This was a randomized, placebo-controlled, observer-blind, phase 2 study to evaluate safety and immunogenicity of the investigational M72/AS01E Mycobacterium tuberculosis (Mtb) vaccine in virally suppressed, antiretroviral-treated participants with human immunodeficiency virus (HIV).
The study was conducted in South Africa.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | M72/AS01E | Participants were randomized to receive an intramuscular dose of M72/AS01E: M72 (10 micrograms of recombinant fusion protein) reconstituted with AS01E (an adjuvant system), on Day 1 and Day 29 |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 26, 2021 | Mar 15, 2024 |
Not provided
Not provided
Not provided
Not provided
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| Placebo | Biological | Participants will receive an intramuscular dose of saline (0.9% NaCl), on Day 1 and Day 29 |
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE does not necessarily have a causal relationship with the intervention. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary card. Number of Participants With Unsolicited AEs Through 28 Days after second vaccination has been presented. |
| Day 29 through Day 57 |
| Number of Participants Reporting Serious AEs (SAEs) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of Participants reporting SAEs has been presented. | Up to Day 390 |
| Up to Day 390 |
| Number of Participants With Clinically Significant Hematology Assessments of Grade 3 or Above After Baseline | Blood samples were collected for the assessment of hemoglobin, leukocytes and platelets. Baseline was defined as last non-missing assessment prior to first vaccination. Laboratory grades were evaluated using the Common Terminology Criteria for AEs (CTCAE version (v)5.0) with grading as: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening or disabling. Number of Participants With Clinically Significant hematology assessments of Grade 3 and Grade 4 has been presented. | Up to Day 390 |
| Number of Participants With Clinically Significant Chemistry Assessments of Grade 3 or Above After Baseline | Blood samples were collected for the assessment of Alanine Aminotransferase, Aspartate Aminotransferase and total bilirubin. Baseline was defined as last non-missing assessment prior to first vaccination. Laboratory grades were evaluated using the CTCAE v5.0 with grading as: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening or disabling. Number of Participants With Clinically Significant chemistry assessments of Grade 3 and Grade 4 has been presented. | Up to Day 390 |
| M72-specific Antibody Titers | Blood samples for immunogenicity evaluation of M72-specific IgG antibody in serum were collected. On Day 1 and Day 29 visits, samples were collected prior to study intervention administration. Humoral M72-specific IgG antibodies were measured by enzyme-linked immunosorbent assay (ELISA). | Day 1, Day 29, Day 57, Day 210 and Day 390 |
| Number of M72 Specific CD4+ and CD8+ T Cell Responders Based on Cytokine Response | Blood samples were analyzed for M72-specific CD4+ and CD8+ T-cell responses based on IFN-gamma and/or IL-2 expression. The CD4+ and CD8+ categories for each timepoint are mutually exclusive. | Day 57 and Day 390 |
| Percentage of M72-specific CD4+ T Cells and CD8+ T Cells Exhibiting Cytokine Response With Background Subtracted | Blood samples were analyzed for M72-specific CD4+ and CD8+ T-cells exhibiting cytokine response (IFN-gamma and/or IL-2) with background subtracted. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) prior to the first study vaccination. | At Baseline, Day 57, and Day 390 |
| Cape Town |
| Khayelitsha |
| 7782 |
| South Africa |
| CAPRISA | Durban | KwaZulu-Natal | 4001 | South Africa |
| The Aurum Institute | Klerksdorp | North West | 2570 | South Africa |
| Desmond Tutu HIV Foundation | Cape Town | Western Cape | 6850 | South Africa |
| SATVI | Worcester | Western Cape | 6850 | South Africa |
Participants were randomized to receive an intramuscular dose of placebo (saline [0.9% sodium chloride {NaCl}]), on Day 1 and Day 29
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population: included all participants randomly assigned to study intervention and who received at least one dose of study intervention
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | M72/AS01E | Participants were randomized to receive an intramuscular dose of M72/AS01E: M72 (10 micrograms of recombinant fusion protein) reconstituted with AS01E (an adjuvant system), on Day 1 and Day 29 |
| BG001 | Placebo | Participants were randomized to receive an intramuscular dose of placebo (saline [0.9% sodium chloride {NaCl}]), on Day 1 and Day 29 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| QuantiFERON®-TB Gold Plus assay status | Count of Participants | Participants |
| ||||||||||||||||
| Cluster of differentiation 4 (CD4+) | Number | 10^6 cells/liter (L) |
| ||||||||||||||||
| Human immunodeficiency virus (HIV) ribonucleic acid (RNA) viral load | Number | copies per mL |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | Kilograms |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Solicited Adverse Events (AEs) Through 7 Days Post Dose 1 of Study Intervention | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE does not necessarily have a causal relationship with the intervention. Solicited AEs were defined events that participants were specifically asked about and which were noted by participants in the diary card. Solicited local AEs included pain, redness and swelling and general body symptoms such as fever, headache, fatigue, gastrointestinal symptoms, and myalgia. | Safety Population: included all participants randomly assigned to study intervention and who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Day 1 through Day 7 (after first vaccination) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Solicited AEs Through 7 Days Post Dose 2 of Study Intervention | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE does not necessarily have a causal relationship with the intervention. Solicited AEs were defined events that participants were specifically asked about and which were noted by participants in the diary card. Solicited local AEs included pain, redness and swelling and general body symptoms such as fever, headache, fatigue, gastrointestinal symptoms, and myalgia. | Safety Population: included all participants randomly assigned to study intervention and who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Day 29 through Day 35 (after second vaccination) |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Unsolicited AEs Through 28 Days Post Dose 1 of Study Intervention | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE does not necessarily have a causal relationship with the intervention. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary card. Number of Participants With Unsolicited AEs Through 28 Days after first vaccination has been presented. | Safety Population. | Posted | Count of Participants | Participants | Day 1 through Day 28 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Unsolicited AEs Through 28 Days Post Dose 2 of Study Intervention | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE does not necessarily have a causal relationship with the intervention. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary card. Number of Participants With Unsolicited AEs Through 28 Days after second vaccination has been presented. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Count of Participants | Participants | Day 29 through Day 57 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Reporting Serious AEs (SAEs) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of Participants reporting SAEs has been presented. | Safety Population | Posted | Count of Participants | Participants | Up to Day 390 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Potential Immune-mediated Diseases (pIMDs) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. pIMDs are a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Number of Participants With Potential Immune-mediated Diseases (pIMDs) has been presented | Safety Population | Posted | Count of Participants | Participants | Up to Day 390 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Hematology Assessments of Grade 3 or Above After Baseline | Blood samples were collected for the assessment of hemoglobin, leukocytes and platelets. Baseline was defined as last non-missing assessment prior to first vaccination. Laboratory grades were evaluated using the Common Terminology Criteria for AEs (CTCAE version (v)5.0) with grading as: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening or disabling. Number of Participants With Clinically Significant hematology assessments of Grade 3 and Grade 4 has been presented. | Safety Population. Only those participants with data available at the specified data points were analyzed | Posted | Count of Participants | Participants | Up to Day 390 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Chemistry Assessments of Grade 3 or Above After Baseline | Blood samples were collected for the assessment of Alanine Aminotransferase, Aspartate Aminotransferase and total bilirubin. Baseline was defined as last non-missing assessment prior to first vaccination. Laboratory grades were evaluated using the CTCAE v5.0 with grading as: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening or disabling. Number of Participants With Clinically Significant chemistry assessments of Grade 3 and Grade 4 has been presented. | Safety Population. Only those participants with data available at the specified data points were analyzed | Posted | Count of Participants | Participants | Up to Day 390 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | M72-specific Antibody Titers | Blood samples for immunogenicity evaluation of M72-specific IgG antibody in serum were collected. On Day 1 and Day 29 visits, samples were collected prior to study intervention administration. Humoral M72-specific IgG antibodies were measured by enzyme-linked immunosorbent assay (ELISA). | Per-Protocol (PP) Population: included all participants randomly assigned to study intervention, who received the study interventions as planned and did not substantially deviate from the protocol procedures. Only those participants with data available at the specified data points were analyzed | Posted | Geometric Mean | 95% Confidence Interval | Equivalent units per mL (EU/mL) | Day 1, Day 29, Day 57, Day 210 and Day 390 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of M72 Specific CD4+ and CD8+ T Cell Responders Based on Cytokine Response | Blood samples were analyzed for M72-specific CD4+ and CD8+ T-cell responses based on IFN-gamma and/or IL-2 expression. The CD4+ and CD8+ categories for each timepoint are mutually exclusive. | Per-Protocol for Cellular Immunogenicity Population comprises all participants in PP population randomly selected to have immunogenicity assays performed. Only those participants with data available at the specified data points were analyzed. | Posted | Count of Participants | Participants | Day 57 and Day 390 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of M72-specific CD4+ T Cells and CD8+ T Cells Exhibiting Cytokine Response With Background Subtracted | Blood samples were analyzed for M72-specific CD4+ and CD8+ T-cells exhibiting cytokine response (IFN-gamma and/or IL-2) with background subtracted. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) prior to the first study vaccination. | Per-Protocol for Cellular Immunogenicity Population comprises all participants in Per-Protocol population randomly selected to have immunogenicity assays performed. Only those participants with data available at specified timepoints has been presented. | Posted | Mean | Standard Deviation | Percentage of cells | At Baseline, Day 57, and Day 390 |
|
|
Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, myalgia, gastrointestinal symptoms, and pyrexia) were recorded on diary cards (systematic assessment) for 7 days after each dose. Solicited events ongoing at Day 7 were collected as unsolicited AEs. Unsolicited AEs were collected through 28 days after each dose, and SAEs (non-systematic assessments) were collected from dosing at Day 1 through Day 390 (end of study).
An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. A participant who had an event ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | M72/AS01E | Participants were randomized to receive an intramuscular dose of M72/AS01E: M72 (10 micrograms of recombinant fusion protein) reconstituted with AS01E (an adjuvant system), on Day 1 and Day 29 | 0 | 201 | 4 | 201 | 191 | 201 |
| EG001 | Placebo | Participants were randomized to receive an intramuscular dose of placebo (saline [0.9% sodium chloride {NaCl}]), on Day 1 and Day 29 | 1 | 200 | 5 | 200 | 158 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 23.1 | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Physical assault | Social circumstances | MedDRA 23.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis allergic | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastrointestinal symptoms | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Gates MRI | +1 857 702 2108 | clinical.trials@gatesmri.org |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 14, 2022 | Mar 15, 2024 | SAP_003.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Southern African Coloured |
|
| Negative |
|
| 200-349*10^6 cells/L |
|
| 350-499*10^6 cells/L |
|
| >=500*10^6 cells/L |
|
| <=200 copies per mL |
|
| >200 copies per mL |
|
| Units | Counts |
|---|
| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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