Trial Outcomes & Findings for Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV (NCT NCT00659789)
NCT ID: NCT00659789
Last Updated: 2017-02-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
137 participants
Primary outcome timeframe
From Week 28 to Week 52
Results posted on
2017-02-23
Participant Flow
The first subject was screened on 29 July 2008 and the first immunization was given on 22 August 2008. The last subject completed the study (to Week 52) on 22 June 2010. The last long-term follow-up visit was 07 June 2011.
137 study participants were enrolled. One participant withdrew prior to randomization.
Participant milestones
| Measure |
Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART
Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
|
Placebo Injections (Group II) While on ART
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
43
|
|
Overall Study
COMPLETED
|
86
|
36
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV
Baseline characteristics by cohort
| Measure |
Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART
n=92 Participants
Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
|
Placebo Injections (Group II) While on ART
n=43 Participants
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age, Categorial · <=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Age, Categorial · Between 15 and 55
|
92 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Age, Customized
Age, Categorial · >=55 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gender
Female
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Gender
Male
|
78 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Height
|
175 cm
n=5 Participants
|
175 cm
n=7 Participants
|
175 cm
n=5 Participants
|
|
Time since HIV diagnosis (days)
|
3861 days
n=5 Participants
|
4480 days
n=7 Participants
|
4309 days
n=5 Participants
|
|
CD4 nadir
|
300 10^6 cells/L
n=5 Participants
|
285 10^6 cells/L
n=7 Participants
|
298 10^6 cells/L
n=5 Participants
|
|
Pre-ART CD4
|
339 10^6 cells/L
n=5 Participants
|
370 10^6 cells/L
n=7 Participants
|
357 10^6 cells/L
n=5 Participants
|
|
Pre-ART HIV-1 viral load
|
94810 copies/mL
n=5 Participants
|
25630 copies/mL
n=7 Participants
|
75398 copies/mL
n=5 Participants
|
|
Total time on ART
|
95.5 months
n=5 Participants
|
112 months
n=7 Participants
|
108 months
n=5 Participants
|
PRIMARY outcome
Timeframe: From Week 28 to Week 52Population: ITT Population
Outcome measures
| Measure |
Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART
n=92 Participants
Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
|
Placebo Injections (Group II) While on ART.
n=43 Participants
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
|
|---|---|---|
|
Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.
Subjects coming off ART at Week 28
|
88 participants
|
38 participants
|
|
Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.
Subjects not qualifying for ART interruption
|
0 participants
|
1 participants
|
|
Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.
Number of subjects attending Week 28 visit
|
88 participants
|
40 participants
|
|
Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.
Subjects resuming ART between week 28 and 52
|
30 participants
|
11 participants
|
|
Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.
Subjects restarting ART at Week 52/termination
|
12 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Up to week 52Population: Safety Population
Brief summary of treatment emergent adverse events or related treatment emergent events and deaths. The intensity of adverse events was described according to the Division of AIDS table for grading severity of adult and pediatric adverse events, 2004.
Outcome measures
| Measure |
Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART
n=93 Participants
Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
|
Placebo Injections (Group II) While on ART.
n=42 Participants
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
|
|---|---|---|
|
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
TEAE - Severe
|
9 participants
|
6 participants
|
|
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
Related TEAE - Severe
|
4 participants
|
0 participants
|
|
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
Any TEAE leading to treatment discontinuation
|
2 participants
|
0 participants
|
|
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
Treatment-related TEAE leading to discontinuation
|
2 participants
|
0 participants
|
|
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
Deaths
|
0 participants
|
1 participants
|
|
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
Any TEAE up to week 52/early termination
|
91 participants
|
40 participants
|
|
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
TEAE - Mild
|
27 participants
|
13 participants
|
|
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
TEAE - Moderate
|
54 participants
|
21 participants
|
|
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
TEAE - Life threatening
|
1 participants
|
0 participants
|
|
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
Related TEAE up to week 52/early termination
|
81 participants
|
24 participants
|
|
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
Related TEAE - Mild
|
40 participants
|
19 participants
|
|
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
Related TEAE - Moderate
|
37 participants
|
5 participants
|
|
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
Related TEAE - Life threatening
|
0 participants
|
0 participants
|
|
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
Any TESAE up to week 52/early termination
|
4 participants
|
3 participants
|
|
Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
Any related TESAE up to week 52/early termination
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 1, week 18 and week 52Population: ITT Population
Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity) reaction. The number of participants showing induration and/or erythema
Outcome measures
| Measure |
Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART
n=92 Participants
Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
|
Placebo Injections (Group II) While on ART.
n=43 Participants
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
|
|---|---|---|
|
Immunogenicity
Induration week 18 (Vacc-4x n=88; placebo n=41)
|
27 participants
|
0 participants
|
|
Immunogenicity
Induration week 52 (Vacc-4x n=78; placebo n=36)
|
26 participants
|
0 participants
|
|
Immunogenicity
Induration week 1 (Vacc-4x n=92; placebo n=43
|
3 participants
|
1 participants
|
|
Immunogenicity
Induration week 52(LOCF) Vacc-4x n=92;placebo n=43
|
30 participants
|
0 participants
|
|
Immunogenicity
Erythema week 1 (Vacc-4x n=92;placebo n=43)
|
3 participants
|
1 participants
|
|
Immunogenicity
Erythema week 18 (Vacc-4x n=88; placebo n=41)
|
40 participants
|
0 participants
|
|
Immunogenicity
Erythema week 52 (Vacc-4x n=78;placebo n=36)
|
34 participants
|
0 participants
|
|
Immunogenicity
Erythema week 52 (LOCF) Vacc-4x n=92;placebo n=43
|
40 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Weeks 6,18,24,28,32,36,40,44,48,52.Population: Subject who stopped ART at week 28 and remained off ART until week 52
CD8 Count Over Time for subjects who stopped ART at Week 28 and remained off ART until Week 52
Outcome measures
| Measure |
Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART
n=56 Participants
Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
|
Placebo Injections (Group II) While on ART.
n=25 Participants
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
|
|---|---|---|
|
Effect of Vacc-4x on CD8 Counts
week 40 (Vacc-4x n=54; placebo n=25)
|
1252.5 cells/µL
Interval 849.0 to 1788.0
|
1253.0 cells/µL
Interval 866.0 to 1592.0
|
|
Effect of Vacc-4x on CD8 Counts
week 44 (Vacc-4x n=56; placebo n=25)
|
1156.0 cells/µL
Interval 799.0 to 1665.0
|
1106.0 cells/µL
Interval 851.0 to 1545.0
|
|
Effect of Vacc-4x on CD8 Counts
week 6 (Vacc-4x n=54;placebo n=25)
|
786.0 cells/µL
Interval 636.0 to 934.0
|
865.0 cells/µL
Interval 544.0 to 1123.0
|
|
Effect of Vacc-4x on CD8 Counts
week 18 (Vacc-4x n=56; placebo n=25)
|
853.5 cells/µL
Interval 686.5 to 1055.0
|
897.0 cells/µL
Interval 604.0 to 1176.0
|
|
Effect of Vacc-4x on CD8 Counts
week 24 (Vacc-4x n=56; placebo n=25)
|
804.0 cells/µL
Interval 583.0 to 1111.5
|
771.0 cells/µL
Interval 592.0 to 1040.0
|
|
Effect of Vacc-4x on CD8 Counts
week 28 (Vacc-4x n=56; placebo n=25)
|
820.5 cells/µL
Interval 670.5 to 1050.5
|
879.0 cells/µL
Interval 570.0 to 1111.0
|
|
Effect of Vacc-4x on CD8 Counts
week 32 (Vacc-4x n=56; placebo n=25)
|
962.0 cells/µL
Interval 694.5 to 1352.5
|
1161.0 cells/µL
Interval 789.0 to 1456.0
|
|
Effect of Vacc-4x on CD8 Counts
week 36 (Vacc-4x n=56; placebo n=25)
|
1385.5 cells/µL
Interval 953.0 to 1748.5
|
1416.0 cells/µL
Interval 1006.0 to 2058.0
|
|
Effect of Vacc-4x on CD8 Counts
week 48 (Vacc-4x n=55; placebo n=24)
|
1118.0 cells/µL
Interval 857.0 to 1641.0
|
1217.0 cells/µL
Interval 827.0 to 1463.5
|
|
Effect of Vacc-4x on CD8 Counts
week 52 (completers) (Vacc-4x n=56;placebo n=25)
|
1064.0 cells/µL
Interval 725.0 to 1368.5
|
1047.0 cells/µL
Interval 747.0 to 1502.0
|
SECONDARY outcome
Timeframe: Between Week 28 to Week 52Population: ITT Population
Kaplan-Meier Estimate of Time to restart ART (from time coming off ART)
Outcome measures
| Measure |
Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART
n=88 Participants
Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
|
Placebo Injections (Group II) While on ART.
n=40 Participants
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
|
|---|---|---|
|
Time to Restart of ART for Vacc-4x Subjects Versus Placebo
|
141.8 days
Standard Deviation 47.40
|
133.5 days
Standard Deviation 57.27
|
SECONDARY outcome
Timeframe: Weeks 24,28,32,36,40,44,48,52.Outcome measures
| Measure |
Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART
n=92 Participants
Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
|
Placebo Injections (Group II) While on ART.
n=43 Participants
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
|
|---|---|---|
|
Effects on Vacc-4x on HIV-1 RNA
week 32 (Vacc-4x n=88; placebo n=38)
|
192115.0 copies/mL
Standard Deviation 361003.40
|
205605.2 copies/mL
Standard Deviation 383020.31
|
|
Effects on Vacc-4x on HIV-1 RNA
week 36 (Vacc-4x n=81; placebo n=35)
|
89134.8 copies/mL
Standard Deviation 165945.62
|
89211.9 copies/mL
Standard Deviation 97983.28
|
|
Effects on Vacc-4x on HIV-1 RNA
week 40 (Vacc-4x n=71; placebo n=32)
|
72705.0 copies/mL
Standard Deviation 143582.93
|
76127.8 copies/mL
Standard Deviation 81891.91
|
|
Effects on Vacc-4x on HIV-1 RNA
week 44 (Vacc-4x n=63; placebo n=27)
|
44969.7 copies/mL
Standard Deviation 65798.22
|
66203.3 copies/mL
Standard Deviation 72099.23
|
|
Effects on Vacc-4x on HIV-1 RNA
week 48 (Vacc-4x n=59; placebo n=25)
|
48848.2 copies/mL
Standard Deviation 90232.17
|
77219.4 copies/mL
Standard Deviation 70851.98
|
|
Effects on Vacc-4x on HIV-1 RNA
week 52 (Vacc-4x n=56; placebo n=24)
|
35219.6 copies/mL
Standard Deviation 42181.85
|
67684.0 copies/mL
Standard Deviation 67869.61
|
|
Effects on Vacc-4x on HIV-1 RNA
week 24 (Vacc-4x n=90; placebo n=41)
|
629.6 copies/mL
Standard Deviation 5807.26
|
9.2 copies/mL
Standard Deviation 22.85
|
|
Effects on Vacc-4x on HIV-1 RNA
week 28 (Vacc-4x n=89; placebo n=40)
|
1351.4 copies/mL
Standard Deviation 5710.99
|
1628.5 copies/mL
Standard Deviation 10131.81
|
Adverse Events
Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART
Serious events: 4 serious events
Other events: 91 other events
Deaths: 0 deaths
Placebo Injections (Group II) While on ART
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART
n=93 participants at risk
Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
|
Placebo Injections (Group II) While on ART
n=42 participants at risk
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
|
|---|---|---|
|
Gastrointestinal disorders
Appendicitis perforated
|
1.1%
1/93 • Number of events 1 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
0.00%
0/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Nervous system disorders
Multiple sclerosis
|
1.1%
1/93 • Number of events 1 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
0.00%
0/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Infections and infestations
Cellulitis of male external genital organ
|
1.1%
1/93 • Number of events 1 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
0.00%
0/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Infections and infestations
Appendicitis
|
1.1%
1/93 • Number of events 1 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
0.00%
0/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Infections and infestations
Postoperative wound infection
|
1.1%
1/93 • Number of events 1 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
0.00%
0/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
General disorders
Necrosis
|
0.00%
0/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
2.4%
1/42 • Number of events 1 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
2.4%
1/42 • Number of events 1 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
2.4%
1/42 • Number of events 1 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
Other adverse events
| Measure |
Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART
n=93 participants at risk
Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
|
Placebo Injections (Group II) While on ART
n=42 participants at risk
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
|
|---|---|---|
|
General disorders
Injection site erythema
|
66.7%
62/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
14.3%
6/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
General disorders
Injection site induration
|
41.9%
39/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
14.3%
6/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
General disorders
Injection site pruritus
|
37.6%
35/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
0.00%
0/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
General disorders
Fatigue
|
11.8%
11/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
11.9%
5/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
General disorders
Injection site pain
|
17.2%
16/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
14.3%
6/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
General disorders
Pyrexia
|
7.5%
7/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
2.4%
1/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
General disorders
Injection site swelling
|
16.1%
15/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
7.1%
3/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
5/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
0.00%
0/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
4/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
4.8%
2/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Nervous system disorders
Headache
|
7.5%
7/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
7.1%
3/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
6/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
2.4%
1/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
General disorders
Influenza-like illness
|
3.2%
3/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
2.4%
1/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
General disorders
Asthenia
|
4.3%
4/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
0.00%
0/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
General disorders
Chills
|
4.3%
4/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
0.00%
0/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
General disorders
Malaise
|
1.1%
1/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
2.4%
1/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
2/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
2.4%
1/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
0.00%
0/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.1%
1/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
0.00%
0/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.2%
3/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
2.4%
1/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
2.4%
1/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.1%
1/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
2.4%
1/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
0.00%
0/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
1/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
0.00%
0/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.2%
2/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
2.4%
1/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Investigations
ALT increased
|
0.00%
0/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
2.4%
1/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Investigations
AST increased
|
0.00%
0/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
2.4%
1/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
|
Vascular disorders
Hypertension
|
1.1%
1/93 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
0.00%
0/42 • Adverse events (AEs) recorded from Screening to Week 52
Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor (or designee) will prepare a final report on the study. The Investigator may not publish or present any information on this study without the express written approval of the Sponsor. Additionally, the Sponsor, may, for any reason, withhold approval for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER