Trial Outcomes & Findings for A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 Years (NCT NCT05989672)
NCT ID: NCT05989672
Last Updated: 2025-06-12
Results Overview
The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
During the 7 days (including the day of vaccination) following vaccination at Day 1
Results posted on
2025-06-12
Participant Flow
Participant milestones
| Measure |
Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI)_F1 Group
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
10
|
|
Overall Study
COMPLETED
|
17
|
20
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI)_F1 Group
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
0
|
Baseline Characteristics
A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 Years
Baseline characteristics by cohort
| Measure |
HSVTI_F1 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.9 YEARS
STANDARD_DEVIATION 8.0 • n=5 Participants
|
27.2 YEARS
STANDARD_DEVIATION 6.7 • n=7 Participants
|
31.4 YEARS
STANDARD_DEVIATION 6.6 • n=5 Participants
|
29.1 YEARS
STANDARD_DEVIATION 7.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
ASIAN - JAPANESE HERITAGE
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During the 7 days (including the day of vaccination) following vaccination at Day 1Population: Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study intervention and have post-vaccination data for the specified analysis at specified timepoints.
The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
HSVTI_F1 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Solicited Administration Site Events
Pain
|
19 Participants
|
18 Participants
|
4 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Erythema
|
8 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Swelling
|
4 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 7 days (including the day of vaccination) following vaccination at Day 29Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
HSVTI_F1 Group
n=17 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Solicited Administration Site Events
Erythema
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Pain
|
15 Participants
|
14 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Swelling
|
4 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 7 days (including the day of vaccination) following vaccination at Day 1Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
The solicited systemic events include arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and fever \[temperature \>=38.0-degree Celsius (°C)\]. Any solicited systemic AEs = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
HSVTI_F1 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Solicited Systemic Events
Arthralgia
|
6 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Fatigue
|
16 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Headache
|
10 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Myalgia
|
11 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Fever
|
3 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 7 days (including the day of vaccination) following vaccination at Day 29Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
The solicited systemic events include arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and fever (temperature \>= 38.0 °C). Any solicited systemic AEs = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
HSVTI_F1 Group
n=17 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Solicited Systemic Events
Arthralgia
|
6 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Fatigue
|
13 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Headache
|
7 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Myalgia
|
9 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Fever
|
5 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 28 days (including the day of vaccination) following vaccination at Day 1Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
An unsolicited AE is an AE that was not included in the list of solicited events. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
HSVTI_F1 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
|
4 Participants
|
4 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: During the 28 days (including the day of vaccination) following vaccination at Day 29Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
An unsolicited AE is an AE that was not included in the list of solicited events. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
HSVTI_F1 Group
n=17 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Unsolicited AEs
|
4 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
MAEs are defined as AEs requiring medically attended visits, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
HSVTI_F1 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Medically Attended Events (MAEs)
|
1 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
An SAE is defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
HSVTI_F1 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
plMDs are defined as a subset of adverse events of special interest (AESI) that include autoimmune diseases and other inflammatory or neurologic disorders that may or may not have an autoimmune etiology. Newly diagnosed pIMDs are categorized as new-onset conditions if they start following the administration of the study intervention. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
HSVTI_F1 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Newly Diagnosed Potential Immune-Mediated Diseases (pIMDs)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
Exacerbation of pre-existing pIMDs is categorized as an exacerbation of a pre-existing chronic condition if the condition worsened following the administration of the study intervention.
Outcome measures
| Measure |
HSVTI_F1 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 1 (pre-study intervention administration)Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Creatinine, Urea nitrogen). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
HSVTI_F1 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
ALT · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
ALT · Within
|
20 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
ALT · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
AST · Within
|
20 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
AST · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Creatinine · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Creatinine · Within
|
20 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Creatinine · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Urea Nitrogen · Below
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Urea Nitrogen · Within
|
18 Participants
|
18 Participants
|
8 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Urea Nitrogen · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Hemoglobin · Below
|
8 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Hemoglobin · Within
|
12 Participants
|
17 Participants
|
8 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Hemoglobin · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Platelets · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Platelets · Within
|
20 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Platelets · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
WBC · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
WBC · Within
|
19 Participants
|
19 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
WBC · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 8 (7 days post dose 1)Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Creatinine, Urea nitrogen). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
HSVTI_F1 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
ALT · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
ALT · Within
|
20 Participants
|
19 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
ALT · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
AST · Within
|
20 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
AST · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Creatinine · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Creatinine · Within
|
19 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Creatinine · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Urea Nitrogen · Below
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Urea Nitrogen · Within
|
18 Participants
|
18 Participants
|
8 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Urea Nitrogen · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Hemoglobin · Below
|
6 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Hemoglobin · Within
|
14 Participants
|
15 Participants
|
8 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Hemoglobin · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Platelets · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Platelets · Within
|
20 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Platelets · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
WBC · Below
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
WBC · Within
|
20 Participants
|
18 Participants
|
9 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
WBC · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 29 (28 days post dose 1)Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Creatinine, Urea nitrogen). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
HSVTI_F1 Group
n=17 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
ALT · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
ALT · Within
|
17 Participants
|
19 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
ALT · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
AST · Within
|
17 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
AST · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Creatinine · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Creatinine · Within
|
16 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Creatinine · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Urea Nitrogen · Below
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Urea Nitrogen · Within
|
16 Participants
|
19 Participants
|
9 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Urea Nitrogen · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Hemoglobin · Below
|
9 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Hemoglobin · Within
|
8 Participants
|
15 Participants
|
8 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Hemoglobin · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Platelets · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Platelets · Within
|
17 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Platelets · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
WBC · Below
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
WBC · Within
|
15 Participants
|
19 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
WBC · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 36 (7 days post dose 2)Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Creatinine, Urea nitrogen). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
HSVTI_F1 Group
n=17 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
ALT · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
ALT · Within
|
17 Participants
|
19 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
ALT · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
AST · Within
|
17 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
AST · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Creatinine · Below
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Creatinine · Within
|
15 Participants
|
20 Participants
|
9 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Creatinine · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Urea Nitrogen · Below
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Urea Nitrogen · Within
|
15 Participants
|
18 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Urea Nitrogen · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Hemoglobin · Below
|
6 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Hemoglobin · Within
|
11 Participants
|
16 Participants
|
8 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Hemoglobin · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Platelets · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Platelets · Within
|
17 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Platelets · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
WBC · Below
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
WBC · Within
|
14 Participants
|
18 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
WBC · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 57 (28 days post dose 2)Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Creatinine, Urea nitrogen). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
HSVTI_F1 Group
n=17 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
ALT · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
ALT · Within
|
17 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
ALT · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
AST · Within
|
17 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
AST · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Creatinine · Below
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Creatinine · Within
|
15 Participants
|
18 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Creatinine · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Urea Nitrogen · Below
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Urea Nitrogen · Within
|
14 Participants
|
18 Participants
|
8 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Urea Nitrogen · Above
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Hemoglobin · Below
|
8 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Hemoglobin · Within
|
9 Participants
|
14 Participants
|
9 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Hemoglobin · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Platelets · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Platelets · Within
|
17 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Platelets · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
WBC · Below
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
WBC · Within
|
16 Participants
|
18 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
WBC · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)Population: Analysis was performed on the Per Protocol set for analysis of humoral immunogenicity (PPS\_Immuno) which included all participants who received all doses as per protocol, have immunogenicity results post-dose, complied with dosing/blood draw intervals, without intercurrent conditions that may interfere with immunogenicity, without prohibited concomitant medication/vaccination and have post-vaccination data for the specified analysis at specified timepoints.
The seropositivity rate of anti-HSVTI antibody was assessed by Enzyme-Linked Immunosorbent Assay (ELISA) and measured in ELISA Units per milliliter (EU/mL).
Outcome measures
| Measure |
HSVTI_F1 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody
Day 1
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
25.0 Percentage of participants
Interval 8.7 to 49.1
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
|
Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody
Day 29
|
100 Percentage of participants
Interval 80.5 to 100.0
|
100 Percentage of participants
Interval 83.2 to 100.0
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
|
Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody
Day 57
|
100 Percentage of participants
Interval 80.5 to 100.0
|
100 Percentage of participants
Interval 83.2 to 100.0
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
SECONDARY outcome
Timeframe: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)Population: Analysis was performed on the PPS\_Immuno. Only participants with data available at specified timepoints were included in the analysis.
Outcome measures
| Measure |
HSVTI_F1 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Anti-HSVTI Antibody Geometric Mean Concentration (GMC)
Day 57
|
558.8 EU/mL
Interval 331.4 to 942.2
|
390.8 EU/mL
Interval 221.9 to 688.3
|
1.1 EU/mL
Interval 0.3 to 4.0
|
|
Anti-HSVTI Antibody Geometric Mean Concentration (GMC)
Day 1
|
1.2 EU/mL
Interval 0.5 to 2.8
|
1.0 EU/mL
Interval 0.5 to 2.0
|
1.1 EU/mL
Interval 0.3 to 3.5
|
|
Anti-HSVTI Antibody Geometric Mean Concentration (GMC)
Day 29
|
270.1 EU/mL
Interval 176.5 to 413.4
|
197.8 EU/mL
Interval 134.6 to 290.7
|
1.1 EU/mL
Interval 0.3 to 3.8
|
SECONDARY outcome
Timeframe: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)Population: Analysis was performed on the Per Protocol set for analysis of cellular immunogenicity (PPS\_CMI) which included all participants who received all doses as per protocol, have CMI results post-dose, complied with dosing/blood draw intervals, without intercurrent conditions that may interfere with immunogenicity, without prohibited concomitant medication/vaccination and have post-vaccination data for the specified analysis at specified timepoints.
The geometric mean of HSVTI CD4+T cells frequency expressing at least 2 markers including at least one cytokine among Interferon \[IFN\]-gamma, Tumour necrosis factor \[TNF\]-alpha, Interleukin \[IL\]-2, IL-13, IL-17, 4-1BB and CD40L were assessed by Intracellular staining (ICS).
Outcome measures
| Measure |
HSVTI_F1 Group
n=19 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency
Day 1
|
64.0 HSVTI-specifc CD4+ T cells/10^6 cells
Standard Deviation 0.9
|
36.3 HSVTI-specifc CD4+ T cells/10^6 cells
Standard Deviation 1.0
|
24.0 HSVTI-specifc CD4+ T cells/10^6 cells
Standard Deviation 0.9
|
|
Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency
Day 29
|
456.8 HSVTI-specifc CD4+ T cells/10^6 cells
Standard Deviation 0.5
|
199.1 HSVTI-specifc CD4+ T cells/10^6 cells
Standard Deviation 0.8
|
21.1 HSVTI-specifc CD4+ T cells/10^6 cells
Standard Deviation 1.1
|
|
Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency
Day 57
|
5899.7 HSVTI-specifc CD4+ T cells/10^6 cells
Standard Deviation 0.4
|
2932.3 HSVTI-specifc CD4+ T cells/10^6 cells
Standard Deviation 0.4
|
40.3 HSVTI-specifc CD4+ T cells/10^6 cells
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)Population: Analysis was performed on the PPS\_CMI. Only participants with data available at specified timepoints were included in the analysis.
The geometric mean of HSVTI CD8+ T cells frequency expressing at least 2 activation markers including at least one cytokine among IFN-gamma, TNF-alpha, IL-2, IL-13, IL- 17, 4-1BB and CD40L were assessed by ICS.
Outcome measures
| Measure |
HSVTI_F1 Group
n=19 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Geometric Mean of HSVTI-specific CD8+ T Cells Frequency
Day 57
|
61.0 HSVTI-specifc CD8+ T cells/10^6 cells
Standard Deviation 0.9
|
20.8 HSVTI-specifc CD8+ T cells/10^6 cells
Standard Deviation 0.8
|
13.5 HSVTI-specifc CD8+ T cells/10^6 cells
Standard Deviation 0.9
|
|
Geometric Mean of HSVTI-specific CD8+ T Cells Frequency
Day 1
|
37.6 HSVTI-specifc CD8+ T cells/10^6 cells
Standard Deviation 0.8
|
19.6 HSVTI-specifc CD8+ T cells/10^6 cells
Standard Deviation 0.9
|
8.7 HSVTI-specifc CD8+ T cells/10^6 cells
Standard Deviation 0.8
|
|
Geometric Mean of HSVTI-specific CD8+ T Cells Frequency
Day 29
|
27.1 HSVTI-specifc CD8+ T cells/10^6 cells
Standard Deviation 1.0
|
9.5 HSVTI-specifc CD8+ T cells/10^6 cells
Standard Deviation 0.8
|
8.6 HSVTI-specifc CD8+ T cells/10^6 cells
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: From Day 1 (dose 1) up to study end (Day 209)Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
Outcome measures
| Measure |
HSVTI_F1 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any MAEs
|
3 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From Day 1 (dose 1) up to study end (Day 209)Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
Outcome measures
| Measure |
HSVTI_F1 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 (dose 1) up to study end (Day 209)Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
Outcome measures
| Measure |
HSVTI_F1 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Newly Diagnosed pIMDs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 (dose 1) up to study end (Day 209)Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
Outcome measures
| Measure |
HSVTI_F1 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 Participants
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 Participants
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
HSVTI_F1 Group
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
HSVTI_F2 Group
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HSVTI_F1 Group
n=20 participants at risk
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
|
HSVTI_F2 Group
n=20 participants at risk
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
|
Placebo Group
n=10 participants at risk
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
10.0%
1/10 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Eye disorders
Eye pain
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Gastrointestinal disorders
Dental abfraction
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
10.0%
1/10 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Gastrointestinal disorders
Salivary gland pain
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
General disorders
Administration site erythema
|
45.0%
9/20 • Number of events 10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
20.0%
4/20 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
General disorders
Administration site pain
|
95.0%
19/20 • Number of events 35 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
95.0%
19/20 • Number of events 32 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
40.0%
4/10 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
General disorders
Administration site pruritus
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
10.0%
2/20 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
General disorders
Administration site swelling
|
25.0%
5/20 • Number of events 8 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
20.0%
4/20 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
General disorders
Chills
|
15.0%
3/20 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
10.0%
2/20 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
General disorders
Fatigue
|
90.0%
18/20 • Number of events 29 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
50.0%
10/20 • Number of events 13 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
10.0%
1/10 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
General disorders
Feeling hot
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
General disorders
Malaise
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
10.0%
1/10 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
General disorders
Pyrexia
|
35.0%
7/20 • Number of events 8 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
20.0%
2/10 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Infections and infestations
COVID-19
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
10.0%
1/10 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
10.0%
1/10 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
10.0%
2/20 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
10.0%
1/10 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
40.0%
8/20 • Number of events 12 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
25.0%
5/20 • Number of events 9 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
75.0%
15/20 • Number of events 20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
40.0%
8/20 • Number of events 13 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
10.0%
1/10 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Nervous system disorders
Headache
|
60.0%
12/20 • Number of events 17 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
30.0%
6/20 • Number of events 7 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
20.0%
2/10 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
10.0%
1/10 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
20.0%
2/10 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
10.0%
1/10 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.0%
1/20 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/20 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
0.00%
0/10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER