Trial Outcomes & Findings for Evaluation of Two Zika Viruses for Use in Controlled Human Infection Models (CHIM) (NCT NCT05123222)
NCT ID: NCT05123222
Last Updated: 2025-04-11
Results Overview
measured by count of solicited adverse events recorded following ZIKV administration
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
Through 90 days post-inoculation
Results posted on
2025-04-11
Participant Flow
Participant milestones
| Measure |
ZIKV-SJRP/2016-184 Strain
Dose of 10ˆ2 PFU
ZIKV-SJRP/2016-184 Strain: Zika Virus Strain (San Jose Rio Puerto)
|
ZIKV-SJRP/2016-184 Strain Placebo
Volume matched placebo injection (saline)
|
ZIKV-Nicaragua/2016 Strain
Dose of 10ˆ2 PFU
Experimental: ZIKV-Nicaragua/2016 Strain: Zika Virus Strain (Nicaragua)
|
ZIKV-Nicaragua/2016 Strain Placebo
Volume matched placebo injection (saline)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
8
|
20
|
8
|
|
Overall Study
COMPLETED
|
18
|
8
|
19
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
ZIKV-SJRP/2016-184 Strain
Dose of 10ˆ2 PFU
ZIKV-SJRP/2016-184 Strain: Zika Virus Strain (San Jose Rio Puerto)
|
ZIKV-SJRP/2016-184 Strain Placebo
Volume matched placebo injection (saline)
|
ZIKV-Nicaragua/2016 Strain
Dose of 10ˆ2 PFU
Experimental: ZIKV-Nicaragua/2016 Strain: Zika Virus Strain (Nicaragua)
|
ZIKV-Nicaragua/2016 Strain Placebo
Volume matched placebo injection (saline)
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Evaluation of Two Zika Viruses for Use in Controlled Human Infection Models (CHIM)
Baseline characteristics by cohort
| Measure |
ZIKV-SJRP/2016-184 Strain
n=20 Participants
ZIKV-SJRP/2016-184 at dose 10\^2 PFU.
|
ZIKV-SJRP/2016-184 Strain Placebo
n=8 Participants
Volume-matched placebo injection (saline).
|
ZIKV-Nicaragua/2016 Strain
n=20 Participants
ZIKV-Nicaragua/2016 at dose 10\^2 PFU.
|
ZIKV-Nicaragua/2016 Strain Placebo
n=8 Participants
Volume-matched placebo injection (saline).
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<18
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
18-50
|
20 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Age, Customized
>=51
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Through 90 days post-inoculationmeasured by count of solicited adverse events recorded following ZIKV administration
Outcome measures
| Measure |
ZIKV-SJRP/2016-184 Strain
n=20 Participants
Dose of 10ˆ2 PFU
ZIKV-SJRP/2016-184 Strain: Zika Virus Strain (San Jose Rio Puerto)
|
ZIKV-SJRP/2016-184 Strain Placebo
n=8 Participants
Volume matched placebo injection (saline)
|
ZIKV-Nicaragua/2016 Strain
n=20 Participants
Dose of 10ˆ2 PFU
Experimental: ZIKV-Nicaragua/2016 Strain: Zika Virus Strain (Nicaragua)
|
ZIKV-Nicaragua/2016 Strain Placebo
n=8 Participants
Volume matched placebo injection (saline)
|
|---|---|---|---|---|
|
Number of Solicited Adverse Events
Injection Site Erythema
|
1 events
|
0 events
|
0 events
|
0 events
|
|
Number of Solicited Adverse Events
Injection Site Tenderness
|
2 events
|
1 events
|
3 events
|
1 events
|
|
Number of Solicited Adverse Events
Injection Site Pain
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Number of Solicited Adverse Events
Injection Site Pruritus
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Number of Solicited Adverse Events
Injection Site Induration
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Number of Solicited Adverse Events
Fever
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Number of Solicited Adverse Events
Headache
|
48 events
|
8 events
|
42 events
|
17 events
|
|
Number of Solicited Adverse Events
Zika-like Rash
|
21 events
|
2 events
|
29 events
|
2 events
|
|
Number of Solicited Adverse Events
Neutropenia
|
2 events
|
0 events
|
2 events
|
0 events
|
|
Number of Solicited Adverse Events
Nonpurulent Conjunctivitis
|
6 events
|
0 events
|
6 events
|
1 events
|
|
Number of Solicited Adverse Events
Myalgia
|
13 events
|
0 events
|
16 events
|
2 events
|
|
Number of Solicited Adverse Events
Arthralgia
|
13 events
|
2 events
|
12 events
|
0 events
|
|
Number of Solicited Adverse Events
Retro-orbital Pain
|
6 events
|
0 events
|
14 events
|
3 events
|
|
Number of Solicited Adverse Events
Fatigue
|
17 events
|
4 events
|
21 events
|
4 events
|
|
Number of Solicited Adverse Events
Muscle Weakness
|
1 events
|
0 events
|
0 events
|
0 events
|
|
Number of Solicited Adverse Events
Hyporeflexia
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Number of Solicited Adverse Events
Thrombocytopenia
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Number of Solicited Adverse Events
Leukopenia
|
2 events
|
0 events
|
7 events
|
0 events
|
|
Number of Solicited Adverse Events
Pruritus
|
4 events
|
0 events
|
1 events
|
1 events
|
|
Number of Solicited Adverse Events
Photophobia
|
5 events
|
1 events
|
7 events
|
0 events
|
PRIMARY outcome
Timeframe: Through 90 days post-inoculationcount of solicited AEs by severity grade 1 - mild, event that is easily tolerated, may require 1 dose of medication. grade 2 - moderate, event that interferes with daily activity or requires more than 1 dose of medication. grade 3 - severe, event that prevents daily activity and requires medical intervention. grade 4 - life-threatening, an adverse event that is deemed by the study clinician, the medical monitor, or an outside clinician caring for the subject to be a life-threatening event. grade 5 - death, any adverse event that results in the death of the subject.
Outcome measures
| Measure |
ZIKV-SJRP/2016-184 Strain
n=20 Participants
Dose of 10ˆ2 PFU
ZIKV-SJRP/2016-184 Strain: Zika Virus Strain (San Jose Rio Puerto)
|
ZIKV-SJRP/2016-184 Strain Placebo
n=8 Participants
Volume matched placebo injection (saline)
|
ZIKV-Nicaragua/2016 Strain
n=20 Participants
Dose of 10ˆ2 PFU
Experimental: ZIKV-Nicaragua/2016 Strain: Zika Virus Strain (Nicaragua)
|
ZIKV-Nicaragua/2016 Strain Placebo
n=8 Participants
Volume matched placebo injection (saline)
|
|---|---|---|---|---|
|
Severity of Adverse Events
Grade 1
|
181 events
|
47 events
|
212 events
|
45 events
|
|
Severity of Adverse Events
Grade 2
|
34 events
|
8 events
|
38 events
|
7 events
|
|
Severity of Adverse Events
Grade 3
|
0 events
|
1 events
|
1 events
|
0 events
|
|
Severity of Adverse Events
Grade 4
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Severity of Adverse Events
Grade 5
|
0 events
|
0 events
|
0 events
|
0 events
|
PRIMARY outcome
Timeframe: Through 90 days post-inoculationInfection defined as recovery of ZIKV by RT-PCR from blood and/or by seroconversion to ZIKV (50% plaque reduction neutralization titer \[PRNT50\]≥ 1:10)
Outcome measures
| Measure |
ZIKV-SJRP/2016-184 Strain
n=20 Participants
Dose of 10ˆ2 PFU
ZIKV-SJRP/2016-184 Strain: Zika Virus Strain (San Jose Rio Puerto)
|
ZIKV-SJRP/2016-184 Strain Placebo
n=8 Participants
Volume matched placebo injection (saline)
|
ZIKV-Nicaragua/2016 Strain
n=20 Participants
Dose of 10ˆ2 PFU
Experimental: ZIKV-Nicaragua/2016 Strain: Zika Virus Strain (Nicaragua)
|
ZIKV-Nicaragua/2016 Strain Placebo
n=8 Participants
Volume matched placebo injection (saline)
|
|---|---|---|---|---|
|
Number of Participants Infected by ZIKV
|
20 Participants
|
0 Participants
|
20 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through 90 days post-inoculationPopulation: Only participants infected by ZIKV. CVS was collected from female participants and semen was collected from male participants.
Count of participants with infectious virus recovered from serum, whole blood, cervicovaginal secretions (CVS), semen, urine, and saliva as measured by RT-PCR
Outcome measures
| Measure |
ZIKV-SJRP/2016-184 Strain
n=20 Participants
Dose of 10ˆ2 PFU
ZIKV-SJRP/2016-184 Strain: Zika Virus Strain (San Jose Rio Puerto)
|
ZIKV-SJRP/2016-184 Strain Placebo
Volume matched placebo injection (saline)
|
ZIKV-Nicaragua/2016 Strain
n=20 Participants
Dose of 10ˆ2 PFU
Experimental: ZIKV-Nicaragua/2016 Strain: Zika Virus Strain (Nicaragua)
|
ZIKV-Nicaragua/2016 Strain Placebo
Volume matched placebo injection (saline)
|
|---|---|---|---|---|
|
Number of Participants With Zika Virus Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Serum
|
20 Participants
|
—
|
20 Participants
|
—
|
|
Number of Participants With Zika Virus Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Whole blood
|
20 Participants
|
—
|
20 Participants
|
—
|
|
Number of Participants With Zika Virus Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Cervicovaginal secretions
|
6 Participants
|
—
|
7 Participants
|
—
|
|
Number of Participants With Zika Virus Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Semen
|
4 Participants
|
—
|
7 Participants
|
—
|
|
Number of Participants With Zika Virus Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Urine
|
10 Participants
|
—
|
7 Participants
|
—
|
|
Number of Participants With Zika Virus Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Saliva
|
8 Participants
|
—
|
7 Participants
|
—
|
PRIMARY outcome
Timeframe: Through 90 days post-inoculationPopulation: Only participants from whom infectious virus was recovered. The number analyzed per specimen type is the number of participants from whom infectious virus was recovered. CVS was collected from female participants and semen was collected from male participants.
Mean peak titer of ZIKV recovered in serum, whole blood, cervicovaginal secretions (cvs), semen, urine, and saliva of participants by RT-PCR. Data are reported in Log10 Genome Equivalents (GE) per milliliter.
Outcome measures
| Measure |
ZIKV-SJRP/2016-184 Strain
n=20 Participants
Dose of 10ˆ2 PFU
ZIKV-SJRP/2016-184 Strain: Zika Virus Strain (San Jose Rio Puerto)
|
ZIKV-SJRP/2016-184 Strain Placebo
Volume matched placebo injection (saline)
|
ZIKV-Nicaragua/2016 Strain
n=20 Participants
Dose of 10ˆ2 PFU
Experimental: ZIKV-Nicaragua/2016 Strain: Zika Virus Strain (Nicaragua)
|
ZIKV-Nicaragua/2016 Strain Placebo
Volume matched placebo injection (saline)
|
|---|---|---|---|---|
|
Magnitude of ZIKV Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Serum
|
5.27 log10GE/mL
Standard Error 0.10
|
—
|
6.26 log10GE/mL
Standard Error 0.10
|
—
|
|
Magnitude of ZIKV Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Whole blood
|
4.46 log10GE/mL
Standard Error 0.11
|
—
|
5.54 log10GE/mL
Standard Error 0.11
|
—
|
|
Magnitude of ZIKV Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
CVS
|
3.28 log10GE/mL
Standard Error 0.50
|
—
|
3.17 log10GE/mL
Standard Error 0.46
|
—
|
|
Magnitude of ZIKV Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Semen
|
5.94 log10GE/mL
Standard Error 1.0
|
—
|
5.22 log10GE/mL
Standard Error 0.76
|
—
|
|
Magnitude of ZIKV Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Urine
|
3.54 log10GE/mL
Standard Error 0.38
|
—
|
3.32 log10GE/mL
Standard Error 0.46
|
—
|
|
Magnitude of ZIKV Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Saliva
|
2.72 log10GE/mL
Standard Error 0.20
|
—
|
2.84 log10GE/mL
Standard Error 0.22
|
—
|
PRIMARY outcome
Timeframe: Through 90 days post-inoculationPopulation: Only participants from whom infectious virus was recovered. The number analyzed per specimen type is the number of participants from whom infectious virus was recovered. CVS was collected from female participants and semen was collected from male participants.
Mean number of days that ZIKV was recovered in serum, whole blood, cervicovaginal secretions (cvs), semen, urine, and saliva from participants with detectable zika as measured by RT-PCR
Outcome measures
| Measure |
ZIKV-SJRP/2016-184 Strain
n=20 Participants
Dose of 10ˆ2 PFU
ZIKV-SJRP/2016-184 Strain: Zika Virus Strain (San Jose Rio Puerto)
|
ZIKV-SJRP/2016-184 Strain Placebo
Volume matched placebo injection (saline)
|
ZIKV-Nicaragua/2016 Strain
n=20 Participants
Dose of 10ˆ2 PFU
Experimental: ZIKV-Nicaragua/2016 Strain: Zika Virus Strain (Nicaragua)
|
ZIKV-Nicaragua/2016 Strain Placebo
Volume matched placebo injection (saline)
|
|---|---|---|---|---|
|
Duration of ZIKV in Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Serum
|
7.3 days
Standard Error 0.47
|
—
|
8.1 days
Standard Error 0.48
|
—
|
|
Duration of ZIKV in Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Whole Blood
|
7.0 days
Standard Error 0.52
|
—
|
6.2 days
Standard Error 0.52
|
—
|
|
Duration of ZIKV in Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Cervicovaginal secretions
|
3.3 days
Standard Error 0.93
|
—
|
4.4 days
Standard Error 0.86
|
—
|
|
Duration of ZIKV in Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Semen
|
7.3 days
Standard Error 3.39
|
—
|
13.0 days
Standard Error 2.57
|
—
|
|
Duration of ZIKV in Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Urine
|
3.1 days
Standard Error 0.96
|
—
|
3.6 days
Standard Error 1.15
|
—
|
|
Duration of ZIKV in Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Saliva
|
2.6 days
Standard Error 1.02
|
—
|
2.7 days
Standard Error 1.10
|
—
|
SECONDARY outcome
Timeframe: Through 28 days post-inoculationNumber of AEs by grade grade 1 - mild, event that is easily tolerated, may require 1 dose of medication. grade 2 - moderate, event that interferes with daily activity or requires more than 1 dose of medication. grade 3 - severe, event that prevents daily activity and requires medical intervention. grade 4 - life-threatening, an adverse event that is deemed by the study clinician, the medical monitor, or an outside clinician caring for the subject to be a life-threatening event. grade 5 - death, any adverse event that results in the death of the subject.
Outcome measures
| Measure |
ZIKV-SJRP/2016-184 Strain
n=20 Participants
Dose of 10ˆ2 PFU
ZIKV-SJRP/2016-184 Strain: Zika Virus Strain (San Jose Rio Puerto)
|
ZIKV-SJRP/2016-184 Strain Placebo
n=8 Participants
Volume matched placebo injection (saline)
|
ZIKV-Nicaragua/2016 Strain
n=20 Participants
Dose of 10ˆ2 PFU
Experimental: ZIKV-Nicaragua/2016 Strain: Zika Virus Strain (Nicaragua)
|
ZIKV-Nicaragua/2016 Strain Placebo
n=8 Participants
Volume matched placebo injection (saline)
|
|---|---|---|---|---|
|
Frequency of AEs by Severity
Grade 1
|
179 events
|
46 events
|
211 events
|
44 events
|
|
Frequency of AEs by Severity
Grade 2
|
32 events
|
7 events
|
34 events
|
5 events
|
|
Frequency of AEs by Severity
Grade 3
|
0 events
|
1 events
|
1 events
|
0 events
|
|
Frequency of AEs by Severity
Grade 4
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Frequency of AEs by Severity
Grade 5
|
0 events
|
0 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: Through 90 days post-inoculationPopulation: Only participants infected by ZIKV. CVS was collected from female participants and semen was collected from male participants.
determined by number of participants with infectious virus in serum, whole blood, cervicovaginal secretions (cvs), semen, urine, and saliva as measured by virus culture
Outcome measures
| Measure |
ZIKV-SJRP/2016-184 Strain
n=20 Participants
Dose of 10ˆ2 PFU
ZIKV-SJRP/2016-184 Strain: Zika Virus Strain (San Jose Rio Puerto)
|
ZIKV-SJRP/2016-184 Strain Placebo
Volume matched placebo injection (saline)
|
ZIKV-Nicaragua/2016 Strain
n=20 Participants
Dose of 10ˆ2 PFU
Experimental: ZIKV-Nicaragua/2016 Strain: Zika Virus Strain (Nicaragua)
|
ZIKV-Nicaragua/2016 Strain Placebo
Volume matched placebo injection (saline)
|
|---|---|---|---|---|
|
Number of Participants With Zika Virus Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Serum
|
20 Participants
|
—
|
20 Participants
|
—
|
|
Number of Participants With Zika Virus Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Whole Blood
|
14 Participants
|
—
|
18 Participants
|
—
|
|
Number of Participants With Zika Virus Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
CVS
|
1 Participants
|
—
|
1 Participants
|
—
|
|
Number of Participants With Zika Virus Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Semen
|
5 Participants
|
—
|
4 Participants
|
—
|
|
Number of Participants With Zika Virus Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Urine
|
3 Participants
|
—
|
2 Participants
|
—
|
|
Number of Participants With Zika Virus Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Saliva
|
7 Participants
|
—
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: Through 90 days post-inoculationPopulation: Only participants from whom infectious virus was recovered. The number analyzed per specimen type is the number of participants from whom infectious virus was recovered. CVS was collected for female participants and semen was collected for male participants.
mean peak titer of ZIKV in participants with ZIKV recovered from serum, whole blood, cervicovaginal secretions (cvs), semen, urine, and saliva by virus culture. Data are reported in Log10 Genome Equivalents (GE) per milliliter.
Outcome measures
| Measure |
ZIKV-SJRP/2016-184 Strain
n=20 Participants
Dose of 10ˆ2 PFU
ZIKV-SJRP/2016-184 Strain: Zika Virus Strain (San Jose Rio Puerto)
|
ZIKV-SJRP/2016-184 Strain Placebo
Volume matched placebo injection (saline)
|
ZIKV-Nicaragua/2016 Strain
n=20 Participants
Dose of 10ˆ2 PFU
Experimental: ZIKV-Nicaragua/2016 Strain: Zika Virus Strain (Nicaragua)
|
ZIKV-Nicaragua/2016 Strain Placebo
Volume matched placebo injection (saline)
|
|---|---|---|---|---|
|
Peak Virus Titer Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Urine
|
1.19 log10GE/mL
Standard Error 0.24
|
—
|
1.0 log10GE/mL
Standard Error 0.29
|
—
|
|
Peak Virus Titer Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Saliva
|
0.96 log10GE/mL
Standard Error 0.23
|
—
|
1.01 log10GE/mL
Standard Error 0.17
|
—
|
|
Peak Virus Titer Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Serum
|
2.12 log10GE/mL
Standard Error 0.17
|
—
|
3.65 log10GE/mL
Standard Error 0.14
|
—
|
|
Peak Virus Titer Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Whole Blood
|
2.20 log10GE/mL
Standard Error 0.11
|
—
|
3.57 log10GE/mL
Standard Error 0.10
|
—
|
|
Peak Virus Titer Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
CVS
|
2.30 log10GE/mL
|
—
|
2.70 log10GE/mL
|
—
|
|
Peak Virus Titer Recovered From Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Semen
|
3.67 log10GE/mL
Standard Error 0.81
|
—
|
3.87 log10GE/mL
Standard Error 0.91
|
—
|
SECONDARY outcome
Timeframe: Through 90 days post-inoculationPopulation: Only participants from whom infectious virus was recovered. The number analyzed per specimen type is the number of participants from whom infectious virus was recovered. CVS was collected from female participants and semen was collected from male participants.
mean number of days that ZIKV was recovered in serum, whole blood, cervicovaginal secretions (cvs), semen, urine, and saliva from participants with detectable zika as measured by virus culture
Outcome measures
| Measure |
ZIKV-SJRP/2016-184 Strain
n=20 Participants
Dose of 10ˆ2 PFU
ZIKV-SJRP/2016-184 Strain: Zika Virus Strain (San Jose Rio Puerto)
|
ZIKV-SJRP/2016-184 Strain Placebo
Volume matched placebo injection (saline)
|
ZIKV-Nicaragua/2016 Strain
n=20 Participants
Dose of 10ˆ2 PFU
Experimental: ZIKV-Nicaragua/2016 Strain: Zika Virus Strain (Nicaragua)
|
ZIKV-Nicaragua/2016 Strain Placebo
Volume matched placebo injection (saline)
|
|---|---|---|---|---|
|
Duration of ZIKV in Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Serum
|
4.8 days
Standard Error 0.24
|
—
|
5.0 days
Standard Error 0.24
|
—
|
|
Duration of ZIKV in Serum, Whole Blood, CVS, Semen, Urine, and Saliva
Whole blood
|
2.8 days
Standard Error 0.38
|
—
|
3.9 days
Standard Error 0.34
|
—
|
|
Duration of ZIKV in Serum, Whole Blood, CVS, Semen, Urine, and Saliva
CVS
|
1.0 days
|
—
|
3.0 days
|
—
|
|
Duration of ZIKV in Serum, Whole Blood, CVS, Semen, Urine, and Saliva
semen
|
3.6 days
Standard Error 1.4
|
—
|
6.0 days
Standard Error 1.57
|
—
|
|
Duration of ZIKV in Serum, Whole Blood, CVS, Semen, Urine, and Saliva
urine
|
1.7 days
Standard Error 0.54
|
—
|
1.0 days
Standard Error 0.67
|
—
|
|
Duration of ZIKV in Serum, Whole Blood, CVS, Semen, Urine, and Saliva
saliva
|
2.1 days
Standard Error 0.77
|
—
|
3.0 days
Standard Error 0.54
|
—
|
SECONDARY outcome
Timeframe: Through 90 days post-inoculationPopulation: participants with at least 1 measurement during the 90-day time period are included in the analysis
evaluate the kinetics of the serum neutralizing antibody response following primary ZIKV infection.
Outcome measures
| Measure |
ZIKV-SJRP/2016-184 Strain
n=18 Participants
Dose of 10ˆ2 PFU
ZIKV-SJRP/2016-184 Strain: Zika Virus Strain (San Jose Rio Puerto)
|
ZIKV-SJRP/2016-184 Strain Placebo
Volume matched placebo injection (saline)
|
ZIKV-Nicaragua/2016 Strain
n=20 Participants
Dose of 10ˆ2 PFU
Experimental: ZIKV-Nicaragua/2016 Strain: Zika Virus Strain (Nicaragua)
|
ZIKV-Nicaragua/2016 Strain Placebo
Volume matched placebo injection (saline)
|
|---|---|---|---|---|
|
Peak Neutralizing Antibody Response to ZIKV
|
6129 log10GE/mL
Standard Error 0
|
—
|
4265 log10GE/mL
Standard Error 0
|
—
|
Adverse Events
ZIKV-SJRP/2016-184 Strain
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
ZIKV-SJRP/2016-184 Strain Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
ZIKV-Nicaragua/2016 Strain
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
ZIKV-Nicaragua/2016 Strain Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ZIKV-SJRP/2016-184 Strain
n=20 participants at risk
Dose of 10ˆ2 PFU
ZIKV-SJRP/2016-184 Strain: Zika Virus Strain (San Jose Rio Puerto)
|
ZIKV-SJRP/2016-184 Strain Placebo
n=8 participants at risk
Volume matched placebo injection (saline)
|
ZIKV-Nicaragua/2016 Strain
n=20 participants at risk
Dose of 10ˆ2 PFU
Experimental: ZIKV-Nicaragua/2016 Strain: Zika Virus Strain (Nicaragua)
|
ZIKV-Nicaragua/2016 Strain Placebo
n=8 participants at risk
Volume matched placebo injection (saline)
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • 180 days
|
Other adverse events
| Measure |
ZIKV-SJRP/2016-184 Strain
n=20 participants at risk
Dose of 10ˆ2 PFU
ZIKV-SJRP/2016-184 Strain: Zika Virus Strain (San Jose Rio Puerto)
|
ZIKV-SJRP/2016-184 Strain Placebo
n=8 participants at risk
Volume matched placebo injection (saline)
|
ZIKV-Nicaragua/2016 Strain
n=20 participants at risk
Dose of 10ˆ2 PFU
Experimental: ZIKV-Nicaragua/2016 Strain: Zika Virus Strain (Nicaragua)
|
ZIKV-Nicaragua/2016 Strain Placebo
n=8 participants at risk
Volume matched placebo injection (saline)
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
2/20 • Number of events 2 • 180 days
|
25.0%
2/8 • Number of events 2 • 180 days
|
25.0%
5/20 • Number of events 9 • 180 days
|
0.00%
0/8 • 180 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
4/20 • Number of events 4 • 180 days
|
0.00%
0/8 • 180 days
|
15.0%
3/20 • Number of events 4 • 180 days
|
0.00%
0/8 • 180 days
|
|
Gastrointestinal disorders
Nausea
|
45.0%
9/20 • Number of events 18 • 180 days
|
37.5%
3/8 • Number of events 4 • 180 days
|
30.0%
6/20 • Number of events 10 • 180 days
|
0.00%
0/8 • 180 days
|
|
General disorders
Insomnia
|
15.0%
3/20 • Number of events 3 • 180 days
|
0.00%
0/8 • 180 days
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
|
Gastrointestinal disorders
Diarrhea
|
15.0%
3/20 • Number of events 3 • 180 days
|
12.5%
1/8 • Number of events 2 • 180 days
|
15.0%
3/20 • Number of events 3 • 180 days
|
0.00%
0/8 • 180 days
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
15.0%
3/20 • Number of events 5 • 180 days
|
0.00%
0/8 • 180 days
|
|
Nervous system disorders
Dysmenorrhea
|
10.0%
2/20 • Number of events 2 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
|
General disorders
Venipuncture site bruise
|
5.0%
1/20 • Number of events 1 • 180 days
|
37.5%
3/8 • Number of events 3 • 180 days
|
40.0%
8/20 • Number of events 11 • 180 days
|
25.0%
2/8 • Number of events 2 • 180 days
|
|
Hepatobiliary disorders
AST increased
|
10.0%
2/20 • Number of events 2 • 180 days
|
25.0%
2/8 • Number of events 2 • 180 days
|
10.0%
2/20 • Number of events 2 • 180 days
|
0.00%
0/8 • 180 days
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
30.0%
6/20 • Number of events 11 • 180 days
|
0.00%
0/8 • 180 days
|
35.0%
7/20 • Number of events 9 • 180 days
|
0.00%
0/8 • 180 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
10.0%
2/20 • Number of events 2 • 180 days
|
25.0%
2/8 • Number of events 4 • 180 days
|
|
Nervous system disorders
Back pain
|
10.0%
2/20 • Number of events 2 • 180 days
|
0.00%
0/8 • 180 days
|
5.0%
1/20 • Number of events 1 • 180 days
|
25.0%
2/8 • Number of events 2 • 180 days
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
15.0%
3/20 • Number of events 3 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
20.0%
4/20 • Number of events 5 • 180 days
|
0.00%
0/8 • 180 days
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
5.0%
1/20 • Number of events 1 • 180 days
|
0.00%
0/8 • 180 days
|
10.0%
2/20 • Number of events 3 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Skin and subcutaneous tissue disorders
Application site pruritus
|
20.0%
4/20 • Number of events 4 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
20.0%
4/20 • Number of events 4 • 180 days
|
25.0%
2/8 • Number of events 2 • 180 days
|
|
General disorders
Injection site tenderness
|
10.0%
2/20 • Number of events 2 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
15.0%
3/20 • Number of events 3 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Nervous system disorders
Headache
|
80.0%
16/20 • Number of events 48 • 180 days
|
62.5%
5/8 • Number of events 8 • 180 days
|
80.0%
16/20 • Number of events 42 • 180 days
|
62.5%
5/8 • Number of events 17 • 180 days
|
|
Skin and subcutaneous tissue disorders
Zika-like rash
|
85.0%
17/20 • Number of events 21 • 180 days
|
25.0%
2/8 • Number of events 2 • 180 days
|
100.0%
20/20 • Number of events 29 • 180 days
|
12.5%
1/8 • Number of events 2 • 180 days
|
|
Immune system disorders
Leukopenia
|
10.0%
2/20 • Number of events 2 • 180 days
|
0.00%
0/8 • 180 days
|
30.0%
6/20 • Number of events 7 • 180 days
|
0.00%
0/8 • 180 days
|
|
Eye disorders
Non-purulent conjunctivitis
|
30.0%
6/20 • Number of events 6 • 180 days
|
0.00%
0/8 • 180 days
|
30.0%
6/20 • Number of events 6 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
3/20 • Number of events 4 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
5.0%
1/20 • Number of events 1 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Hepatobiliary disorders
ALT increased
|
20.0%
4/20 • Number of events 4 • 180 days
|
37.5%
3/8 • Number of events 8 • 180 days
|
15.0%
3/20 • Number of events 4 • 180 days
|
0.00%
0/8 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
10/20 • Number of events 13 • 180 days
|
0.00%
0/8 • 180 days
|
65.0%
13/20 • Number of events 16 • 180 days
|
25.0%
2/8 • Number of events 2 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
45.0%
9/20 • Number of events 13 • 180 days
|
12.5%
1/8 • Number of events 2 • 180 days
|
45.0%
9/20 • Number of events 12 • 180 days
|
0.00%
0/8 • 180 days
|
|
Eye disorders
Photophobia
|
15.0%
3/20 • Number of events 4 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
20.0%
4/20 • Number of events 7 • 180 days
|
0.00%
0/8 • 180 days
|
|
Eye disorders
Retro-orbital pain
|
25.0%
5/20 • Number of events 6 • 180 days
|
0.00%
0/8 • 180 days
|
40.0%
8/20 • Number of events 14 • 180 days
|
25.0%
2/8 • Number of events 3 • 180 days
|
|
General disorders
Fatigue
|
50.0%
10/20 • Number of events 17 • 180 days
|
50.0%
4/8 • Number of events 4 • 180 days
|
70.0%
14/20 • Number of events 22 • 180 days
|
50.0%
4/8 • Number of events 4 • 180 days
|
|
Psychiatric disorders
Anxiety
|
10.0%
2/20 • Number of events 2 • 180 days
|
0.00%
0/8 • 180 days
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20 • Number of events 1 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
|
Gastrointestinal disorders
Hiatal hernia
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
|
Immune system disorders
Leukocytosis
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • Number of events 6 • 180 days
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Muscle ache
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
|
General disorders
Light headedness
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
5.0%
1/20 • Number of events 2 • 180 days
|
0.00%
0/8 • 180 days
|
|
Skin and subcutaneous tissue disorders
Basal cell carcinoma
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Infections and infestations
Common cold
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Infections and infestations
Covid-19
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
5.0%
1/20 • Number of events 1 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Infections and infestations
Flu
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
5.0%
1/20 • Number of events 1 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
General disorders
Injection site bruising
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
10.0%
2/20 • Number of events 2 • 180 days
|
0.00%
0/8 • 180 days
|
|
Injury, poisoning and procedural complications
Dog bite
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
General disorders
Syncope
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
5.0%
1/20 • Number of events 1 • 180 days
|
0.00%
0/8 • 180 days
|
|
General disorders
Tooth pain
|
0.00%
0/20 • 180 days
|
25.0%
2/8 • Number of events 2 • 180 days
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
|
General disorders
Seasonal allergic rhinitis
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • Number of events 4 • 180 days
|
|
General disorders
Night sweats
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
10.0%
2/20 • Number of events 2 • 180 days
|
0.00%
0/8 • 180 days
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Nervous system disorders
Concussion
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Infections and infestations
Fungal infection
|
0.00%
0/20 • 180 days
|
0.00%
0/8 • 180 days
|
0.00%
0/20 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place