Trial Outcomes & Findings for Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine M72/AS01E in Participants With Well-controlled HIV (NCT NCT04556981)

Last Updated: 2025-07-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

402 participants

Primary outcome timeframe

Day 1 through Day 7 (after first vaccination)

Results posted on

2025-07-17

Participant Flow

The study was conducted in South Africa.

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).

Participant milestones

Participant milestones
Measure	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	Placebo Participants were randomized to receive an intramuscular dose of placebo (saline \[0.9% sodium chloride {NaCl}\]), on Day 1 and Day 29
Overall Study STARTED	202	200
Overall Study COMPLETED	195	181
Overall Study NOT COMPLETED	7	19

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Placebo Participants were randomized to receive an intramuscular dose of placebo (saline \[0.9% sodium chloride {NaCl}\]), on Day 1 and Day 29
Overall Study Death	0	1
Overall Study Lost to Follow-up	2	11
Overall Study Moved from the study area	1	4
Overall Study Withdrawal by Subject	2	2
Overall Study Other	2	1

Baseline Characteristics

Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine M72/AS01E in Participants With Well-controlled HIV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	M72/AS01E n=201 Participants 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	Placebo n=200 Participants Participants were randomized to receive an intramuscular dose of placebo (saline \[0.9% sodium chloride {NaCl}\]), on Day 1 and Day 29	Total n=401 Participants Total of all reporting groups
Age, Continuous	29.4 Years STANDARD_DEVIATION 4.17 • n=5 Participants	29.6 Years STANDARD_DEVIATION 4.47 • n=7 Participants	29.5 Years STANDARD_DEVIATION 4.32 • n=5 Participants
Sex: Female, Male Female	175 Participants n=5 Participants	176 Participants n=7 Participants	351 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	201 Participants n=5 Participants	200 Participants n=7 Participants	401 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black	196 Participants n=5 Participants	196 Participants n=7 Participants	392 Participants n=5 Participants
Race/Ethnicity, Customized Southern African Coloured	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
QuantiFERON®-TB Gold Plus assay status Positive	93 Participants n=5 Participants	100 Participants n=7 Participants	193 Participants n=5 Participants
QuantiFERON®-TB Gold Plus assay status Negative	108 Participants n=5 Participants	100 Participants n=7 Participants	208 Participants n=5 Participants
Cluster of differentiation 4 (CD4+) <200*10^6 cells/L	0 10^6 cells/liter (L) n=5 Participants	0 10^6 cells/liter (L) n=7 Participants	0 10^6 cells/liter (L) n=5 Participants
Cluster of differentiation 4 (CD4+) 200-349*10^6 cells/L	7 10^6 cells/liter (L) n=5 Participants	5 10^6 cells/liter (L) n=7 Participants	12 10^6 cells/liter (L) n=5 Participants
Cluster of differentiation 4 (CD4+) 350-499*10^6 cells/L	20 10^6 cells/liter (L) n=5 Participants	24 10^6 cells/liter (L) n=7 Participants	44 10^6 cells/liter (L) n=5 Participants
Cluster of differentiation 4 (CD4+) >=500*10^6 cells/L	174 10^6 cells/liter (L) n=5 Participants	171 10^6 cells/liter (L) n=7 Participants	345 10^6 cells/liter (L) n=5 Participants
Human immunodeficiency virus (HIV) ribonucleic acid (RNA) viral load Not Detected	162 copies per mL n=5 Participants	162 copies per mL n=7 Participants	324 copies per mL n=5 Participants
Human immunodeficiency virus (HIV) ribonucleic acid (RNA) viral load <=200 copies per mL	36 copies per mL n=5 Participants	35 copies per mL n=7 Participants	71 copies per mL n=5 Participants
Human immunodeficiency virus (HIV) ribonucleic acid (RNA) viral load >200 copies per mL	3 copies per mL n=5 Participants	3 copies per mL n=7 Participants	6 copies per mL n=5 Participants
Weight	73.4 Kilograms STANDARD_DEVIATION 19.93 • n=5 Participants	74.3 Kilograms STANDARD_DEVIATION 18.81 • n=7 Participants	73.8 Kilograms STANDARD_DEVIATION 19.36 • n=5 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 7 (after first vaccination)

Population: Safety Population: included all participants randomly assigned to study intervention and who received at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	M72/AS01E n=201 Participants 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	Placebo n=200 Participants Participants were randomized to receive an intramuscular dose of placebo (saline \[0.9% sodium chloride {NaCl}\]), on Day 1 and Day 29
Number of Participants With Solicited Adverse Events (AEs) Through 7 Days Post Dose 1 of Study Intervention Any injection site symptom	155 Participants	49 Participants
Number of Participants With Solicited Adverse Events (AEs) Through 7 Days Post Dose 1 of Study Intervention Any general body symptom	132 Participants	109 Participants

PRIMARY outcome

Timeframe: Day 29 through Day 35 (after second vaccination)

Population: Safety Population: included all participants randomly assigned to study intervention and who received at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	M72/AS01E n=201 Participants 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	Placebo n=200 Participants Participants were randomized to receive an intramuscular dose of placebo (saline \[0.9% sodium chloride {NaCl}\]), on Day 1 and Day 29
Number of Participants With Solicited AEs Through 7 Days Post Dose 2 of Study Intervention Any injection site symptom	147 Participants	29 Participants
Number of Participants With Solicited AEs Through 7 Days Post Dose 2 of Study Intervention Any general body symptom	134 Participants	83 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 28

Population: Safety Population.

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.

Outcome measures

Outcome measures
Measure	M72/AS01E n=201 Participants 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	Placebo n=200 Participants Participants were randomized to receive an intramuscular dose of placebo (saline \[0.9% sodium chloride {NaCl}\]), on Day 1 and Day 29
Number of Participants With Unsolicited AEs Through 28 Days Post Dose 1 of Study Intervention	67 Participants	67 Participants

PRIMARY outcome

Timeframe: Day 29 through Day 57

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

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.

Outcome measures

Outcome measures
Measure	M72/AS01E n=185 Participants 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	Placebo n=188 Participants Participants were randomized to receive an intramuscular dose of placebo (saline \[0.9% sodium chloride {NaCl}\]), on Day 1 and Day 29
Number of Participants With Unsolicited AEs Through 28 Days Post Dose 2 of Study Intervention	53 Participants	41 Participants

PRIMARY outcome

Timeframe: Up to Day 390

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	M72/AS01E n=201 Participants 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	Placebo n=200 Participants Participants were randomized to receive an intramuscular dose of placebo (saline \[0.9% sodium chloride {NaCl}\]), on Day 1 and Day 29
Number of Participants Reporting Serious AEs (SAEs)	4 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to Day 390

Population: Safety Population

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

Outcome measures

Outcome measures
Measure	M72/AS01E n=201 Participants 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	Placebo n=200 Participants Participants were randomized to receive an intramuscular dose of placebo (saline \[0.9% sodium chloride {NaCl}\]), on Day 1 and Day 29
Number of Participants With Potential Immune-mediated Diseases (pIMDs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 390

Population: Safety Population. Only those participants with data available at the specified data points were analyzed

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.

Outcome measures

Outcome measures
Measure	M72/AS01E n=197 Participants 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	Placebo n=191 Participants Participants were randomized to receive an intramuscular dose of placebo (saline \[0.9% sodium chloride {NaCl}\]), on Day 1 and Day 29
Number of Participants With Clinically Significant Hematology Assessments of Grade 3 or Above After Baseline Hemoglobin: Grade 4	0 Participants	0 Participants
Number of Participants With Clinically Significant Hematology Assessments of Grade 3 or Above After Baseline Leukocytes: Grade 3	0 Participants	0 Participants
Number of Participants With Clinically Significant Hematology Assessments of Grade 3 or Above After Baseline Leukocytes: Grade 4	0 Participants	0 Participants
Number of Participants With Clinically Significant Hematology Assessments of Grade 3 or Above After Baseline Platelets: Grade 3	0 Participants	0 Participants
Number of Participants With Clinically Significant Hematology Assessments of Grade 3 or Above After Baseline Platelets: Grade 4	0 Participants	0 Participants
Number of Participants With Clinically Significant Hematology Assessments of Grade 3 or Above After Baseline Hemoglobin: Grade 3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 390

Population: Safety Population. Only those participants with data available at the specified data points were analyzed

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.

Outcome measures

Outcome measures
Measure	M72/AS01E n=197 Participants 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	Placebo n=191 Participants Participants were randomized to receive an intramuscular dose of placebo (saline \[0.9% sodium chloride {NaCl}\]), on Day 1 and Day 29
Number of Participants With Clinically Significant Chemistry Assessments of Grade 3 or Above After Baseline Alanine Aminotransferase: Grade 3	0 Participants	1 Participants
Number of Participants With Clinically Significant Chemistry Assessments of Grade 3 or Above After Baseline Alanine Aminotransferase: Grade 4	0 Participants	0 Participants
Number of Participants With Clinically Significant Chemistry Assessments of Grade 3 or Above After Baseline Aspartate Aminotransferase: Grade 3	0 Participants	1 Participants
Number of Participants With Clinically Significant Chemistry Assessments of Grade 3 or Above After Baseline Aspartate Aminotransferase: Grade 4	0 Participants	0 Participants
Number of Participants With Clinically Significant Chemistry Assessments of Grade 3 or Above After Baseline Total bilirubin: Grade 3	0 Participants	0 Participants
Number of Participants With Clinically Significant Chemistry Assessments of Grade 3 or Above After Baseline Total bilirubin: Grade 4	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1, Day 29, Day 57, Day 210 and Day 390

Population: 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

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).

Outcome measures

Outcome measures
Measure	M72/AS01E n=143 Participants 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	Placebo n=130 Participants Participants were randomized to receive an intramuscular dose of placebo (saline \[0.9% sodium chloride {NaCl}\]), on Day 1 and Day 29
M72-specific Antibody Titers Day 1	2.72 Equivalent units per mL (EU/mL) Interval 2.69 to 2.76	2.77 Equivalent units per mL (EU/mL) Interval 2.69 to 2.85
M72-specific Antibody Titers Day 29	13.28 Equivalent units per mL (EU/mL) Interval 10.99 to 16.04	2.77 Equivalent units per mL (EU/mL) Interval 2.69 to 2.86
M72-specific Antibody Titers Day 57	479.70 Equivalent units per mL (EU/mL) Interval 421.79 to 545.56	2.77 Equivalent units per mL (EU/mL) Interval 2.69 to 2.86
M72-specific Antibody Titers Day 210	52.23 Equivalent units per mL (EU/mL) Interval 44.83 to 60.86	2.77 Equivalent units per mL (EU/mL) Interval 2.7 to 2.85
M72-specific Antibody Titers Day 390	32.43 Equivalent units per mL (EU/mL) Interval 27.94 to 37.65	2.77 Equivalent units per mL (EU/mL) Interval 2.69 to 2.85

SECONDARY outcome

Timeframe: Day 57 and Day 390

Population: 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.

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.

Outcome measures

Outcome measures
Measure	M72/AS01E n=96 Participants 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	Placebo n=32 Participants Participants were randomized to receive an intramuscular dose of placebo (saline \[0.9% sodium chloride {NaCl}\]), on Day 1 and Day 29
Number of M72 Specific CD4+ and CD8+ T Cell Responders Based on Cytokine Response CD4+ Responders on Day 57	92 Participants	6 Participants
Number of M72 Specific CD4+ and CD8+ T Cell Responders Based on Cytokine Response CD4+ non-responders on Day 57	4 Participants	25 Participants
Number of M72 Specific CD4+ and CD8+ T Cell Responders Based on Cytokine Response CD4+ Responders on Day 390	85 Participants	8 Participants
Number of M72 Specific CD4+ and CD8+ T Cell Responders Based on Cytokine Response CD4+ non-responders on Day 390	11 Participants	24 Participants
Number of M72 Specific CD4+ and CD8+ T Cell Responders Based on Cytokine Response CD8+ Responders on Day 57	14 Participants	3 Participants
Number of M72 Specific CD4+ and CD8+ T Cell Responders Based on Cytokine Response CD8+ non-responders on Day 57	82 Participants	28 Participants
Number of M72 Specific CD4+ and CD8+ T Cell Responders Based on Cytokine Response CD8+ Responders on Day 390	10 Participants	3 Participants
Number of M72 Specific CD4+ and CD8+ T Cell Responders Based on Cytokine Response CD8+ non-Responders on Day 390	86 Participants	29 Participants

SECONDARY outcome

Timeframe: At Baseline, Day 57, and Day 390

Population: 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.

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.

Outcome measures

Outcome measures
Measure	M72/AS01E n=96 Participants 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	Placebo n=32 Participants Participants were randomized to receive an intramuscular dose of placebo (saline \[0.9% sodium chloride {NaCl}\]), on Day 1 and Day 29
Percentage of M72-specific CD4+ T Cells and CD8+ T Cells Exhibiting Cytokine Response With Background Subtracted CD4+ at Baseline	0.062 Percentage of cells Standard Deviation 0.506	0.067 Percentage of cells Standard Deviation 0.167
Percentage of M72-specific CD4+ T Cells and CD8+ T Cells Exhibiting Cytokine Response With Background Subtracted CD4+ at Day 57	0.534 Percentage of cells Standard Deviation 0.556	0.014 Percentage of cells Standard Deviation 0.096
Percentage of M72-specific CD4+ T Cells and CD8+ T Cells Exhibiting Cytokine Response With Background Subtracted CD4+ at Day 390	0.339 Percentage of cells Standard Deviation 0.375	0.047 Percentage of cells Standard Deviation 0.169
Percentage of M72-specific CD4+ T Cells and CD8+ T Cells Exhibiting Cytokine Response With Background Subtracted CD8+ at Baseline	0.071 Percentage of cells Standard Deviation 0.248	0.092 Percentage of cells Standard Deviation 0.353
Percentage of M72-specific CD4+ T Cells and CD8+ T Cells Exhibiting Cytokine Response With Background Subtracted CD8+ at Day 57	0.092 Percentage of cells Standard Deviation 0.272	-0.007 Percentage of cells Standard Deviation 0.042
Percentage of M72-specific CD4+ T Cells and CD8+ T Cells Exhibiting Cytokine Response With Background Subtracted CD8+ at Day 390	0.090 Percentage of cells Standard Deviation 0.328	0.058 Percentage of cells Standard Deviation 0.371

Adverse Events

M72/AS01E

Serious events: 4 serious events

Other events: 191 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 158 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	M72/AS01E n=201 participants at risk 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	Placebo n=200 participants at risk Participants were randomized to receive an intramuscular dose of placebo (saline \[0.9% sodium chloride {NaCl}\]), on Day 1 and Day 29
Infections and infestations COVID-19	0.50% 1/201 • 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.	0.50% 1/200 • 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.
Infections and infestations Anal abscess	0.00% 0/201 • 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.	0.50% 1/200 • 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.
Injury, poisoning and procedural complications Tibia fracture	0.50% 1/201 • 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.	0.00% 0/200 • 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.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.50% 1/201 • 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.	0.50% 1/200 • 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.
Psychiatric disorders Psychotic disorder	0.50% 1/201 • 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.	0.00% 0/200 • 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.
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/201 • 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.	0.50% 1/200 • 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.
Social circumstances Physical assault	0.00% 0/201 • 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.	0.50% 1/200 • 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.

Other adverse events

Additional Information

Study Director

Gates MRI

Phone: +1 857 702 2108

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER