Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With or Without Merck Aluminum Adjuvant (V710-002) (NCT NCT01324440)
NCT ID: NCT01324440
Last Updated: 2015-04-10
Results Overview
Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
COMPLETED
PHASE1
64 participants
Baseline and Day 14 postvaccination
2015-04-10
Participant Flow
Participant milestones
| Measure |
V710 With MAA
Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
|
V710 Without MAA
Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
V710 With MAA
Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
|
V710 Without MAA
Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
|
|---|---|---|
|
Overall Study
Subject moved
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With or Without Merck Aluminum Adjuvant (V710-002)
Baseline characteristics by cohort
| Measure |
V710 With MAA
n=32 Participants
Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
|
V710 Without MAA
n=32 Participants
Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
17 and under
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Age, Customized
18 to 29
|
6 participants
n=99 Participants
|
5 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Age, Customized
30 to 39
|
1 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Age, Customized
40 to 49
|
9 participants
n=99 Participants
|
7 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Age, Customized
50 to 59
|
12 participants
n=99 Participants
|
10 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Age, Customized
60 to 69
|
4 participants
n=99 Participants
|
6 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Age, Customized
Over 69
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 14 postvaccinationPopulation: The per-protocol analysis excluded patients who had missing baseline and/or postvaccination (Day 14) serology data and patients who developed a S. aureus infection during the 14 days postvaccination.
Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
Outcome measures
| Measure |
V710 With MAA
n=32 Participants
Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
|
V710 Without MAA
n=32 Participants
Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
|
|---|---|---|
|
Number of Participants With a Positive Immune Response, Defined as a Change in Antibody Level Greater Than or Equal to a 2-fold-rise at Day 14 Compared to Baseline
|
27 participants
|
23 participants
|
PRIMARY outcome
Timeframe: Day 14 postvaccinationPopulation: The per-protocol analysis excluded patients who had missing baseline and/or postvaccination (Day 14) serology data and patients who developed a S. aureus infection during the 14 days postvaccination.
Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
Outcome measures
| Measure |
V710 With MAA
n=32 Participants
Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
|
V710 Without MAA
n=32 Participants
Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
|
|---|---|---|
|
Geometric Mean Antibody Concentrations (GMC)
|
115.4 mcg/mL
Interval 82.9 to 160.6
|
99.1 mcg/mL
Interval 73.5 to 133.6
|
PRIMARY outcome
Timeframe: Baseline and Day 14 postvaccinationPopulation: The per-protocol analysis excluded patients who had missing baseline and/or postvaccination (Day 14) serology data and patients who developed a S. aureus infection during the 14 days postvaccination.
Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay. The GMFR is the ratio of the antibody concentration at Day 14 to the antibody concentration at baseline.
Outcome measures
| Measure |
V710 With MAA
n=32 Participants
Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
|
V710 Without MAA
n=32 Participants
Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
|
|---|---|---|
|
Change in Antibody Concentration (Titer) at Day 14 Compared to Baseline, Expressed as the Geometric Mean Fold-rise (GMFR)
|
4.5 ratio of IgG titer at Day 14 to baseline
Interval 3.3 to 6.1
|
4.0 ratio of IgG titer at Day 14 to baseline
Interval 2.9 to 5.4
|
PRIMARY outcome
Timeframe: Up to Day 360 postvaccinationPopulation: Any subject who received clinical material and had at least 1 day of safety follow-up was included in the safety summary.
Investigators were instructed to determine the seriousness and causality (relatedness to test vaccine) of each AE based on criteria defined in the protocol: A serious adverse event (SAE) is any AE that: * results in death, * is life threatening, * results in a persistent or significant disability/incapacity, * results in or prolongs an existing inpatient hospitalization, * is a congenital anomaly/birth defect, * is a cancer, * is an overdose, * or is another important medical event that may require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
V710 With MAA
n=32 Participants
Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
|
V710 Without MAA
n=32 Participants
Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
|
|---|---|---|
|
Number of Vaccine-related Serious Adverse Experiences
|
0 participants
|
0 participants
|
Adverse Events
V710 With MAA
V710 Without MAA
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
V710 With MAA
n=32 participants at risk
Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
|
V710 Without MAA
n=32 participants at risk
Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
|
Gastrointestinal disorders
Toothache
|
6.2%
2/32 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
|
General disorders
Fatigue
|
6.2%
2/32 • Number of events 2
|
9.4%
3/32 • Number of events 3
|
|
General disorders
Feeling hot
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
General disorders
Injection site bruising
|
9.4%
3/32 • Number of events 3
|
3.1%
1/32 • Number of events 1
|
|
General disorders
Injection site erythema
|
12.5%
4/32 • Number of events 4
|
6.2%
2/32 • Number of events 2
|
|
General disorders
Injection site pain
|
31.2%
10/32 • Number of events 11
|
18.8%
6/32 • Number of events 8
|
|
General disorders
Injection site pruritus
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
|
General disorders
Injection site swelling
|
6.2%
2/32 • Number of events 2
|
12.5%
4/32 • Number of events 4
|
|
General disorders
Injection site warmth
|
3.1%
1/32 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
|
General disorders
Pain
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
|
General disorders
Pyrexia
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Oral herpes
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
2/32 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint sprain
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.4%
3/32 • Number of events 3
|
3.1%
1/32 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
6.2%
2/32 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
|
Nervous system disorders
Headache
|
15.6%
5/32 • Number of events 5
|
18.8%
6/32 • Number of events 6
|
|
Nervous system disorders
Sinus headache
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck 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