Trial Outcomes & Findings for VSV-ZEBOV Geneva Vaccine Trial (NCT NCT02287480)
NCT ID: NCT02287480
Last Updated: 2023-05-10
Results Overview
Primary immunogenicity outcome (required for dose selection)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
115 participants
Primary outcome timeframe
Day 0 - 28
Results posted on
2023-05-10
Participant Flow
Participant milestones
| Measure |
VSV-ZEBOV High Dose
One intramuscular (deltoid) injection of a "high" dose (10\^7 plaque-forming units) of VSV-ZEBOV.
VSV-ZEBOV: See arm/group descriptions.
|
VSV-ZEBOV Highest Dose
One intramuscular (deltoid) injection of a "highest" dose (5 x 10\^7 pfu) of VSV-ZEBOV.
VSV-ZEBOV: See arm/group descriptions.
|
Placebo
One intramuscular (deltoid) injection of normal saline (0.5 ml)
VSV-ZEBOV: See arm/group descriptions.
|
VSV-ZEBOV Lowest Dose
Study amendment (01.2015) : One intramuscular (deltoid) injection of a markedly lower dose (3x 10\^5 plaque-forming units) of VSV-ZEBOV
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
16
|
13
|
51
|
|
Overall Study
COMPLETED
|
35
|
16
|
13
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VSV-ZEBOV Geneva Vaccine Trial
Baseline characteristics by cohort
| Measure |
VSV-ZEBOV High Dose
n=35 Participants
One intramuscular (deltoid) injection of a "high" dose (10\^7 plaque-forming units) of VSV-ZEBOV.
VSV-ZEBOV: See arm/group descriptions.
|
VSV-ZEBOV Highest Dose
n=16 Participants
One intramuscular (deltoid) injection of a "highest" dose (5 x 10\^7 pfu) of VSV-ZEBOV.
VSV-ZEBOV: See arm/group descriptions.
|
Placebo
n=13 Participants
One intramuscular (deltoid) injection of normal saline (0.5 ml)
VSV-ZEBOV: See arm/group descriptions.
|
VSV-ZEBOV Lowest Dose
n=51 Participants
Study amendment (01.2015) : One intramuscular (deltoid) injection of a markedly lower dose (3x 10\^5 plaque-forming units) of VSV-ZEBOV
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44 years
n=5 Participants
|
39 years
n=7 Participants
|
39 years
n=5 Participants
|
40 years
n=4 Participants
|
41 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Region of Enrollment
Switzerland
|
35 participants
n=5 Participants
|
16 participants
n=7 Participants
|
13 participants
n=5 Participants
|
51 participants
n=4 Participants
|
115 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 0 - 28Population: Note that for many analyses, volunteers vaccinated with either 10\^7 or 5x 10\^7 pfu were grouped together, as these doses were indistinguishable in immunogenicity and safety profile; see Huttner et al. Lancet Infectious Diseases 2015, Agnandji et al., NEJM 2016.
Primary immunogenicity outcome (required for dose selection)
Outcome measures
| Measure |
VSV-ZEBOV 5x 10^7 OR 10^7 Pfu/ml Dose
n=47 Participants
Volunteers vaccinated with a single intramuscular (deltoid) injection of either 5x 10\^7 plaque-forming units/ml of VSV-ZEBOV or 10\^7 pfu/ml of VSV-ZEBOV.
Note that these two doses proved to be indistinguishable in terms of safety profile and immunogenicity, so the groups were combined for results reporting.
|
Placebo
n=13 Participants
One intramuscular (deltoid) injection of normal saline (0.5 ml).
|
VSV-ZEBOV 3x 10^5 Pfu/ml Dose
n=51 Participants
One intramuscular injection (deltoid) of 3x 10\^5 pfu/ml of VSV-ZEBOV.
|
VSV-ZEBOV 3x10^5 Pfu Dose
Study amendment (01.2015) : One intramuscular (deltoid) injection of a markedly lower dose (3x 10\^5 plaque-forming units) of VSV-ZEBOV
|
|---|---|---|---|---|
|
Titers of ZEBOV-specific IgG Antibodies
|
1227 ELISA units per ml
Interval 917.3 to 1641.2
|
25 ELISA units per ml
Interval 25.0 to 25.0
|
344.5 ELISA units per ml
Interval 229.7 to 516.4
|
—
|
SECONDARY outcome
Timeframe: Days 0 - 14Number of participants with solicited local and systemic reactogenicity signs and symptoms. Day 0 is the day of the study intervention.
Outcome measures
| Measure |
VSV-ZEBOV 5x 10^7 OR 10^7 Pfu/ml Dose
n=51 Participants
Volunteers vaccinated with a single intramuscular (deltoid) injection of either 5x 10\^7 plaque-forming units/ml of VSV-ZEBOV or 10\^7 pfu/ml of VSV-ZEBOV.
Note that these two doses proved to be indistinguishable in terms of safety profile and immunogenicity, so the groups were combined for results reporting.
|
Placebo
n=13 Participants
One intramuscular (deltoid) injection of normal saline (0.5 ml).
|
VSV-ZEBOV 3x 10^5 Pfu/ml Dose
n=51 Participants
One intramuscular injection (deltoid) of 3x 10\^5 pfu/ml of VSV-ZEBOV.
|
VSV-ZEBOV 3x10^5 Pfu Dose
Study amendment (01.2015) : One intramuscular (deltoid) injection of a markedly lower dose (3x 10\^5 plaque-forming units) of VSV-ZEBOV
|
|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms
Swelling/induration
|
2 participants
|
0 participants
|
1 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms
Erythema
|
1 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms
Pain at injection site
|
23 participants
|
3 participants
|
9 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms
Objective fever
|
10 participants
|
0 participants
|
1 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms
Subjective fever
|
20 participants
|
2 participants
|
7 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms
Chills
|
19 participants
|
2 participants
|
14 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms
Myalgia
|
22 participants
|
3 participants
|
14 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms
Headache
|
19 participants
|
4 participants
|
12 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms
Fatigue
|
20 participants
|
4 participants
|
24 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms
Arthralgia
|
6 participants
|
1 participants
|
5 participants
|
—
|
SECONDARY outcome
Timeframe: Days 0 - 28Number of participants with unsolicited adverse events in the 28 days following injection
Outcome measures
| Measure |
VSV-ZEBOV 5x 10^7 OR 10^7 Pfu/ml Dose
n=51 Participants
Volunteers vaccinated with a single intramuscular (deltoid) injection of either 5x 10\^7 plaque-forming units/ml of VSV-ZEBOV or 10\^7 pfu/ml of VSV-ZEBOV.
Note that these two doses proved to be indistinguishable in terms of safety profile and immunogenicity, so the groups were combined for results reporting.
|
Placebo
n=13 Participants
One intramuscular (deltoid) injection of normal saline (0.5 ml).
|
VSV-ZEBOV 3x 10^5 Pfu/ml Dose
n=51 Participants
One intramuscular injection (deltoid) of 3x 10\^5 pfu/ml of VSV-ZEBOV.
|
VSV-ZEBOV 3x10^5 Pfu Dose
Study amendment (01.2015) : One intramuscular (deltoid) injection of a markedly lower dose (3x 10\^5 plaque-forming units) of VSV-ZEBOV
|
|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events
|
11 Participants
|
0 Participants
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: Days 0 - 365Number of participants with a serious adverse event (SAE) in the 365 days (1 year) following injection.
Outcome measures
| Measure |
VSV-ZEBOV 5x 10^7 OR 10^7 Pfu/ml Dose
n=51 Participants
Volunteers vaccinated with a single intramuscular (deltoid) injection of either 5x 10\^7 plaque-forming units/ml of VSV-ZEBOV or 10\^7 pfu/ml of VSV-ZEBOV.
Note that these two doses proved to be indistinguishable in terms of safety profile and immunogenicity, so the groups were combined for results reporting.
|
Placebo
n=13 Participants
One intramuscular (deltoid) injection of normal saline (0.5 ml).
|
VSV-ZEBOV 3x 10^5 Pfu/ml Dose
n=51 Participants
One intramuscular injection (deltoid) of 3x 10\^5 pfu/ml of VSV-ZEBOV.
|
VSV-ZEBOV 3x10^5 Pfu Dose
Study amendment (01.2015) : One intramuscular (deltoid) injection of a markedly lower dose (3x 10\^5 plaque-forming units) of VSV-ZEBOV
|
|---|---|---|---|---|
|
Number of Participants With a Serious Adverse Event (SAE)
|
1 number of participants
|
0 number of participants
|
1 number of participants
|
—
|
SECONDARY outcome
Timeframe: Days 1, 3 and 7Population: (Note that viremia data for placebo recipients is not reported because these recipients never received vaccine, were never viremic, and thus these data were not collected in these participants.)
Magnitude (copies/ml) of VSVΔG-ZEBOV viremia as expressed by median VSV RNA concentrations after vaccination.
Outcome measures
| Measure |
VSV-ZEBOV 5x 10^7 OR 10^7 Pfu/ml Dose
n=51 Participants
Volunteers vaccinated with a single intramuscular (deltoid) injection of either 5x 10\^7 plaque-forming units/ml of VSV-ZEBOV or 10\^7 pfu/ml of VSV-ZEBOV.
Note that these two doses proved to be indistinguishable in terms of safety profile and immunogenicity, so the groups were combined for results reporting.
|
Placebo
n=51 Participants
One intramuscular (deltoid) injection of normal saline (0.5 ml).
|
VSV-ZEBOV 3x 10^5 Pfu/ml Dose
One intramuscular injection (deltoid) of 3x 10\^5 pfu/ml of VSV-ZEBOV.
|
VSV-ZEBOV 3x10^5 Pfu Dose
Study amendment (01.2015) : One intramuscular (deltoid) injection of a markedly lower dose (3x 10\^5 plaque-forming units) of VSV-ZEBOV
|
|---|---|---|---|---|
|
Magnitude (Copies/ml) of VSVΔG-ZEBOV Viremia
VSV viremia, day 1
|
323 VSV RNA copies/ml
Interval 65.0 to 912.0
|
15 VSV RNA copies/ml
Interval 15.0 to 15.0
|
—
|
—
|
|
Magnitude (Copies/ml) of VSVΔG-ZEBOV Viremia
VSV viremia, day 3 (±1)
|
178 VSV RNA copies/ml
Interval 65.0 to 676.0
|
15 VSV RNA copies/ml
Interval 15.0 to 15.0
|
—
|
—
|
|
Magnitude (Copies/ml) of VSVΔG-ZEBOV Viremia
VSV viremia, day 7 (±1)
|
15 VSV RNA copies/ml
Interval 15.0 to 15.0
|
15 VSV RNA copies/ml
Interval 15.0 to 15.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 168The percentage of participants maintaining positive ZEBOV-specific IgG antibody titers at 168 days after vaccination.
Outcome measures
| Measure |
VSV-ZEBOV 5x 10^7 OR 10^7 Pfu/ml Dose
n=51 Participants
Volunteers vaccinated with a single intramuscular (deltoid) injection of either 5x 10\^7 plaque-forming units/ml of VSV-ZEBOV or 10\^7 pfu/ml of VSV-ZEBOV.
Note that these two doses proved to be indistinguishable in terms of safety profile and immunogenicity, so the groups were combined for results reporting.
|
Placebo
n=13 Participants
One intramuscular (deltoid) injection of normal saline (0.5 ml).
|
VSV-ZEBOV 3x 10^5 Pfu/ml Dose
n=51 Participants
One intramuscular injection (deltoid) of 3x 10\^5 pfu/ml of VSV-ZEBOV.
|
VSV-ZEBOV 3x10^5 Pfu Dose
Study amendment (01.2015) : One intramuscular (deltoid) injection of a markedly lower dose (3x 10\^5 plaque-forming units) of VSV-ZEBOV
|
|---|---|---|---|---|
|
Persistence of Titers of ZEBOV-specific IgG Antibodies
|
51 Participants
|
0 Participants
|
49 Participants
|
—
|
SECONDARY outcome
Timeframe: Days 0, 28 and 168Population: Note that data were ultimately not collected for days 7 and 14.
Geometric mean titers of neutralizing ZEBOV-specific IgG antibodies.
Outcome measures
| Measure |
VSV-ZEBOV 5x 10^7 OR 10^7 Pfu/ml Dose
n=35 Participants
Volunteers vaccinated with a single intramuscular (deltoid) injection of either 5x 10\^7 plaque-forming units/ml of VSV-ZEBOV or 10\^7 pfu/ml of VSV-ZEBOV.
Note that these two doses proved to be indistinguishable in terms of safety profile and immunogenicity, so the groups were combined for results reporting.
|
Placebo
n=15 Participants
One intramuscular (deltoid) injection of normal saline (0.5 ml).
|
VSV-ZEBOV 3x 10^5 Pfu/ml Dose
n=13 Participants
One intramuscular injection (deltoid) of 3x 10\^5 pfu/ml of VSV-ZEBOV.
|
VSV-ZEBOV 3x10^5 Pfu Dose
n=51 Participants
Study amendment (01.2015) : One intramuscular (deltoid) injection of a markedly lower dose (3x 10\^5 plaque-forming units) of VSV-ZEBOV
|
|---|---|---|---|---|
|
Titers of Neutralizing ZEBOV-specific IgG Antibodies
GMT, day 168
|
7.23 Geometric mean titer
Interval 5.72 to 8.74
|
5.86 Geometric mean titer
Interval 4.49 to 7.23
|
4.54 Geometric mean titer
Interval 4.08 to 4.99
|
6.12 Geometric mean titer
Interval 5.39 to 6.85
|
|
Titers of Neutralizing ZEBOV-specific IgG Antibodies
GMT, day 0
|
4.24 Geometric mean titer
Interval 3.91 to 4.57
|
4.00 Geometric mean titer
Interval 4.0 to 4.0
|
4.00 Geometric mean titer
Interval 4.0 to 4.0
|
4.22 Geometric mean titer
Interval 4.03 to 4.41
|
|
Titers of Neutralizing ZEBOV-specific IgG Antibodies
GMT, day 28
|
13.24 Geometric mean titer
Interval 8.84 to 17.64
|
16.02 Geometric mean titer
Interval 10.23 to 21.81
|
4.11 Geometric mean titer
Interval 3.95 to 4.26
|
14.79 Geometric mean titer
Interval 11.55 to 18.02
|
SECONDARY outcome
Timeframe: Days 1, 3 and 7Percentage of participants with any detectable viremia on days 1, 3 and 7
Outcome measures
| Measure |
VSV-ZEBOV 5x 10^7 OR 10^7 Pfu/ml Dose
n=51 Participants
Volunteers vaccinated with a single intramuscular (deltoid) injection of either 5x 10\^7 plaque-forming units/ml of VSV-ZEBOV or 10\^7 pfu/ml of VSV-ZEBOV.
Note that these two doses proved to be indistinguishable in terms of safety profile and immunogenicity, so the groups were combined for results reporting.
|
Placebo
n=51 Participants
One intramuscular (deltoid) injection of normal saline (0.5 ml).
|
VSV-ZEBOV 3x 10^5 Pfu/ml Dose
One intramuscular injection (deltoid) of 3x 10\^5 pfu/ml of VSV-ZEBOV.
|
VSV-ZEBOV 3x10^5 Pfu Dose
Study amendment (01.2015) : One intramuscular (deltoid) injection of a markedly lower dose (3x 10\^5 plaque-forming units) of VSV-ZEBOV
|
|---|---|---|---|---|
|
Duration of VSVΔG-ZEBOV Viremia
day 1
|
42 Participants
|
6 Participants
|
—
|
—
|
|
Duration of VSVΔG-ZEBOV Viremia
day 3
|
39 Participants
|
8 Participants
|
—
|
—
|
|
Duration of VSVΔG-ZEBOV Viremia
day 7
|
1 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 3 and 7Population: Participants in whom shedding of vaccine virus (VSV) was detected in urine or saliva.
This outcome was evaluated in a subset of vaccinees.
Outcome measures
| Measure |
VSV-ZEBOV 5x 10^7 OR 10^7 Pfu/ml Dose
n=30 Participants
Volunteers vaccinated with a single intramuscular (deltoid) injection of either 5x 10\^7 plaque-forming units/ml of VSV-ZEBOV or 10\^7 pfu/ml of VSV-ZEBOV.
Note that these two doses proved to be indistinguishable in terms of safety profile and immunogenicity, so the groups were combined for results reporting.
|
Placebo
n=5 Participants
One intramuscular (deltoid) injection of normal saline (0.5 ml).
|
VSV-ZEBOV 3x 10^5 Pfu/ml Dose
One intramuscular injection (deltoid) of 3x 10\^5 pfu/ml of VSV-ZEBOV.
|
VSV-ZEBOV 3x10^5 Pfu Dose
Study amendment (01.2015) : One intramuscular (deltoid) injection of a markedly lower dose (3x 10\^5 plaque-forming units) of VSV-ZEBOV
|
|---|---|---|---|---|
|
Number of Participants in Whom Shedding of VSVΔG-ZEBOV Was Detected in Urine and/or Saliva.
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
VSV-ZEBOV 10^7 Pfu Dose
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
VSV-ZEBOV 5x10'^7 Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VSV-ZEBOV 3x10^5 Pfu Dose
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VSV-ZEBOV 10^7 Pfu Dose
n=35 participants at risk
One intramuscular (deltoid) injection of a lower dose (10\^7 plaque-forming units) of VSV-ZEBOV.
VSV-ZEBOV: See arm/group descriptions.
|
VSV-ZEBOV 5x10'^7 Dose
n=16 participants at risk
One intramuscular (deltoid) injection of a higher dose (5 x 10\^7 pfu) of VSV-ZEBOV.
Study amendment (01.2015) : interrupted
VSV-ZEBOV: See arm/group descriptions.
|
Placebo
n=13 participants at risk
One intramuscular (deltoid) injection of normal saline (0.5 ml)
VSV-ZEBOV: See arm/group descriptions.
|
VSV-ZEBOV 3x10^5 Pfu Dose
n=51 participants at risk
Study amendment (01.2015) : One intramuscular (deltoid) injection of a markedly lower dose (3x 10\^5 plaque-forming units) of VSV-ZEBOV
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hospitalization for left ulnar fracture after a fall
|
2.9%
1/35 • Number of events 1 • Non-serious adverse events were collected in the first 28 days. (Serious adverse events were collected throughout the entire study period, an average of 1 year.)
|
0.00%
0/16 • Non-serious adverse events were collected in the first 28 days. (Serious adverse events were collected throughout the entire study period, an average of 1 year.)
|
0.00%
0/13 • Non-serious adverse events were collected in the first 28 days. (Serious adverse events were collected throughout the entire study period, an average of 1 year.)
|
0.00%
0/51 • Non-serious adverse events were collected in the first 28 days. (Serious adverse events were collected throughout the entire study period, an average of 1 year.)
|
|
Musculoskeletal and connective tissue disorders
Hospitalization for rupture of the right quadriceps tendon after a fall
|
0.00%
0/35 • Non-serious adverse events were collected in the first 28 days. (Serious adverse events were collected throughout the entire study period, an average of 1 year.)
|
0.00%
0/16 • Non-serious adverse events were collected in the first 28 days. (Serious adverse events were collected throughout the entire study period, an average of 1 year.)
|
0.00%
0/13 • Non-serious adverse events were collected in the first 28 days. (Serious adverse events were collected throughout the entire study period, an average of 1 year.)
|
2.0%
1/51 • Number of events 1 • Non-serious adverse events were collected in the first 28 days. (Serious adverse events were collected throughout the entire study period, an average of 1 year.)
|
Other adverse events
| Measure |
VSV-ZEBOV 10^7 Pfu Dose
n=35 participants at risk
One intramuscular (deltoid) injection of a lower dose (10\^7 plaque-forming units) of VSV-ZEBOV.
VSV-ZEBOV: See arm/group descriptions.
|
VSV-ZEBOV 5x10'^7 Dose
n=16 participants at risk
One intramuscular (deltoid) injection of a higher dose (5 x 10\^7 pfu) of VSV-ZEBOV.
Study amendment (01.2015) : interrupted
VSV-ZEBOV: See arm/group descriptions.
|
Placebo
n=13 participants at risk
One intramuscular (deltoid) injection of normal saline (0.5 ml)
VSV-ZEBOV: See arm/group descriptions.
|
VSV-ZEBOV 3x10^5 Pfu Dose
n=51 participants at risk
Study amendment (01.2015) : One intramuscular (deltoid) injection of a markedly lower dose (3x 10\^5 plaque-forming units) of VSV-ZEBOV
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
arthritis
|
22.9%
8/35 • Number of events 8 • Non-serious adverse events were collected in the first 28 days. (Serious adverse events were collected throughout the entire study period, an average of 1 year.)
|
18.8%
3/16 • Number of events 3 • Non-serious adverse events were collected in the first 28 days. (Serious adverse events were collected throughout the entire study period, an average of 1 year.)
|
0.00%
0/13 • Non-serious adverse events were collected in the first 28 days. (Serious adverse events were collected throughout the entire study period, an average of 1 year.)
|
25.5%
13/51 • Number of events 13 • Non-serious adverse events were collected in the first 28 days. (Serious adverse events were collected throughout the entire study period, an average of 1 year.)
|
Additional Information
Prof. Claire-Anne Siegrist
Geneva University Hospitals
Phone: 0041 22 379 5778
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place