Trial Outcomes & Findings for Persistence of Protection by Shingrix (NCT NCT04169009)
NCT ID: NCT04169009
Last Updated: 2024-10-15
Results Overview
Varicella-Zoster Virus (VZV) DNAemia will be measured by polymerase chain reaction (PCR) as a surrogate for viremia over the first 7 days after vOka intradermal (ID) challenge. The outcome measure will be the area under the concentration time curve of the VZV DNAemia expressed in DNA copies/ml of blood.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
105 participants
Primary outcome timeframe
Until VZV DNA is undetectable in the blood, measured up to Day 7
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
ZVL >5 Years Previously (Cohort 1)
Participants have received Zostavax (ZVL) at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.
Zostavax: Intradermal injection of Zostavax
|
ZVL 6-12 Months Previously (Cohort 3)
Participants who received ZVL 6-12 months previously will be administered an intradermal dose of vOka varicella zoster virus (ZVL) in non-dominant deltoid.
Zostavax: Intradermal injection of Zostavax
|
No Previous ZVL (Cohort 4
Participants who've never received a shingles vaccine will be given the 2 standard doses of RZV. Six months later they will be given the intradermal dose of vOka varicella zoster virus (ZVL) in the non-dominant deltoid.
Zostavax: Intradermal injection of Zostavax
Shingrix: Given to subjects in Arm 4 who've never had a herpes zoster vaccine
|
SRX >5 Years Previously (Cohort 2)
Participants have received Shingrix at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.
Zostavax: Intradermal injection of Zostavax
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
32
|
35
|
20
|
|
Overall Study
COMPLETED
|
18
|
31
|
35
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Persistence of Protection by Shingrix
Baseline characteristics by cohort
| Measure |
ZVL >5 Years Previously (Cohort 1)
n=18 Participants
Participants have received Zostavax (ZVL) at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.
Zostavax: Intradermal injection of Zostavax
|
ZVL 6-12 Months Previously (Cohort 3)
n=32 Participants
Participants who received ZVL 6-12 months previously will be administered an intradermal dose of vOka varicella zoster virus (ZVL) in non-dominant deltoid.
Zostavax: Intradermal injection of Zostavax
|
No Previous ZVL (Cohort 4
n=35 Participants
Participants who've never received a shingles vaccine will be given the 2 standard doses of RZV. Six months later they will be given the intradermal dose of vOka varicella zoster virus (ZVL) in the non-dominant deltoid.
Zostavax: Intradermal injection of Zostavax
Shingrix: Given to subjects in Arm 4 who've never had a herpes zoster vaccine
|
SRX >5 Years Previously (Cohort 2)
n=20 Participants
Participants have received Shingrix at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.
Zostavax: Intradermal injection of Zostavax
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
78 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
|
Age, Continuous
|
65.14 years
n=99 Participants
|
56.37 years
n=107 Participants
|
61.15 years
n=206 Participants
|
67.79 years
n=7 Participants
|
60.74 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
66 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
39 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
16 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
92 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
32 participants
n=107 Participants
|
35 participants
n=206 Participants
|
20 participants
n=7 Participants
|
104 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Until VZV DNA is undetectable in the blood, measured up to Day 7Varicella-Zoster Virus (VZV) DNAemia will be measured by polymerase chain reaction (PCR) as a surrogate for viremia over the first 7 days after vOka intradermal (ID) challenge. The outcome measure will be the area under the concentration time curve of the VZV DNAemia expressed in DNA copies/ml of blood.
Outcome measures
| Measure |
ZVL >5 Years Previously (Cohort 1)
n=18 Participants
Participants have received Zostavax (ZVL) at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.
Zostavax: Intradermal injection of Zostavax
|
ZVL 6-12 Months Previously (Cohort 3)
n=32 Participants
Participants who received ZVL 6-12 months previously will be administered an intradermal dose of vOka varicella zoster virus (ZVL) in non-dominant deltoid.
Zostavax: Intradermal injection of Zostavax
|
No Previous ZVL (Cohort 4
n=35 Participants
Participants who've never received a shingles vaccine will be given the 2 standard doses of RZV. Six months later they will be given the intradermal dose of vOka varicella zoster virus (ZVL) in the non-dominant deltoid.
Zostavax: Intradermal injection of Zostavax
Shingrix: Given to subjects in Arm 4 who've never had a herpes zoster vaccine
|
SRX >5 Years Previously (Cohort 2)
n=20 Participants
Participants have received Shingrix at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.
Zostavax: Intradermal injection of Zostavax
|
|---|---|---|---|---|
|
Magnitude of Varicella-Zoster Virus (VZV) DNAemia
|
NA DNA copies per/mL
Standard Deviation NA
Viral load below lloq (lower limit of quantification)
|
NA DNA copies per/mL
Standard Deviation NA
Viral load below lloq (lower limit of quantification)
|
NA DNA copies per/mL
Standard Deviation NA
Viral load below lloq (lower limit of quantification)
|
NA DNA copies per/mL
Standard Deviation NA
Viral load below lloq (lower limit of quantification)
|
Adverse Events
ZVL >5 Years Previously (Cohort 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ZVL 6-12 Months Previously (Cohort 3)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Previous ZVL (Cohort 4)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
SRX >5 Years Previously (Cohort 2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ZVL >5 Years Previously (Cohort 1)
n=18 participants at risk
Participants have received Zostavax (ZVL) at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.
Zostavax: Intradermal injection of Zostavax
|
ZVL 6-12 Months Previously (Cohort 3)
n=32 participants at risk
Participants who received ZVL 6-12 months previously will be administered an intradermal dose of vOka varicella zoster virus (ZVL) in non-dominant deltoid.
Zostavax: Intradermal injection of Zostavax
|
No Previous ZVL (Cohort 4)
n=35 participants at risk
Participants who've never received a shingles vaccine will be given the 2 standard doses of RZV. Six months later they will be given the intradermal dose of vOka varicella zoster virus (ZVL) in the non-dominant deltoid.
Zostavax: Intradermal injection of Zostavax
Shingrix: Given to subjects in Arm 4 who've never had a herpes zoster vaccine
|
SRX >5 Years Previously (Cohort 2)
n=20 participants at risk
Participants have received Shingrix at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.
Zostavax: Intradermal injection of Zostavax
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Body aches
|
0.00%
0/18 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/32 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
11.4%
4/35 • Number of events 4 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/20 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
|
Musculoskeletal and connective tissue disorders
shaking chills
|
0.00%
0/18 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/32 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
5.7%
2/35 • Number of events 2 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/20 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
|
General disorders
Lymphedema
|
0.00%
0/18 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/32 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
2.9%
1/35 • Number of events 1 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/20 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
|
Gastrointestinal disorders
nausea and vomiting
|
0.00%
0/18 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/32 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
2.9%
1/35 • Number of events 1 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
5.0%
1/20 • Number of events 1 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
|
Musculoskeletal and connective tissue disorders
decreased range of motion LUE
|
0.00%
0/18 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/32 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
2.9%
1/35 • Number of events 1 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/20 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
|
General disorders
Injection site pain
|
0.00%
0/18 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/32 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
2.9%
1/35 • Number of events 1 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/20 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
|
General disorders
dizziness
|
0.00%
0/18 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/32 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
5.7%
2/35 • Number of events 2 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/20 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
|
General disorders
fever
|
0.00%
0/18 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/32 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
2.9%
1/35 • Number of events 1 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/20 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
|
Musculoskeletal and connective tissue disorders
Worsening back pain
|
0.00%
0/18 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/32 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
2.9%
1/35 • Number of events 1 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/20 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
|
General disorders
malaise
|
0.00%
0/18 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/32 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
2.9%
1/35 • Number of events 1 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/20 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
|
General disorders
felt feverish
|
0.00%
0/18 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/32 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
2.9%
1/35 • Number of events 1 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
0.00%
0/20 • AEs starting within 7 days after injection and Grade ≥ 3 will be recorded and followed until resolution. ZVL - Subjects in Cohort 3 receiving ZVL on Day 0 will be followed for AEs for 7 days. RZV - Subjects in Cohort 4 receiving RZV on Day 0 and Day 60 will also be followed for AEs for 7 days after each injection. Any Grade ≥ 3 will be recorded and followed until resolution. All study procedure AEs will be followed until resolution.
|
Additional Information
Adriana Weinberg MD
University of Colorado Anschutz Medical Campus
Phone: 303-724-4480
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place