Trial Outcomes & Findings for Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans (NCT NCT02796001)
NCT ID: NCT02796001
Last Updated: 2022-06-06
Results Overview
Number infected after re-challenge with RV16 compared to RV39 as determined by virus isolation in cell culture or viral serology
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Volunteers were cultured daily for detection of virus shedding for 5 days after the virus re-challenge and serum was collected for viral serology 4 weeks after virus re-challenge
Results posted on
2022-06-06
Participant Flow
Volunteers who participated in the study were individuals who had previously been challenged and infected with RV16 in the human rhinovirus experimental challenge model and agreed to be re-challenged with either RV16 or RV39
Volunteers were initially challenged with RV16 to provide a uniform baseline for the subsequent randomization and re-challenge with either a homologous serotype (RV16) or a heterologous serotype (RV39). 46 subjects met the baseline criteria but 3 declined further participation and 1 was ill on the day of re-challenge and was removed from the study by the investigator. 42 subjects were randomized and re-challenged with rhinovirus.
Participant milestones
| Measure |
RV16 Infected Volunteers Re-challenged With RV16
volunteers re-challenged with RV16
human rhinovirus: human rhinovirus
|
RV16 Infected Volunteers Re-challenged With RV39
volunteers re-challenged with RV39
human rhinovirus: human rhinovirus
|
no Intervention
4 volunteers were infected with RV16 and were eligible to be randomized to re-challenge. Three of these volunteers declined re-challenge and one was removed from the study prior to re-challenge
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
4
|
|
Overall Study
COMPLETED
|
20
|
22
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans
Baseline characteristics by cohort
| Measure |
RV16 Infected Volunteers Re-challenged With RV16
n=20 Participants
volunteers re-challenged with RV16
human rhinovirus: human rhinovirus
|
RV16 Infected Volunteers Re-challenged With RV39
n=22 Participants
volunteers re-challenged with RV39
human rhinovirus: human rhinovirus
|
no Intervention
n=4 Participants
4 volunteers were infected with RV16 and were eligible for re-challenge. Three volunteers declined re-challenge and one was removed from the study prior to re-challenge
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20.7 years
STANDARD_DEVIATION 2.43 • n=93 Participants
|
19.8 years
STANDARD_DEVIATION 1.87 • n=4 Participants
|
19.25 years
STANDARD_DEVIATION 0.5 • n=27 Participants
|
20.1 years
STANDARD_DEVIATION 1.91 • n=483 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
37 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
22 participants
n=4 Participants
|
4 participants
n=27 Participants
|
46 participants
n=483 Participants
|
|
previously infected with RV16
|
20 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
46 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Volunteers were cultured daily for detection of virus shedding for 5 days after the virus re-challenge and serum was collected for viral serology 4 weeks after virus re-challengePopulation: all volunteers re-challenged
Number infected after re-challenge with RV16 compared to RV39 as determined by virus isolation in cell culture or viral serology
Outcome measures
| Measure |
RV16 Infected Volunteers Re-challenged With RV16
n=20 Participants
volunteers re-challenged with RV16
human rhinovirus: human rhinovirus
|
RV16 Infected Volunteers Re-challenged With RV39
n=22 Participants
volunteers re-challenged with RV39
human rhinovirus: human rhinovirus
|
|---|---|---|
|
Virus Infection
|
8 Participants
|
18 Participants
|
Adverse Events
Volunteers Initially Challenged With RV16
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
RV16 Infected Volunteers Re-challenged With RV16
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
RV16 Infected Volunteers Re-challenged With RV39
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 |
Volunteers Initially Challenged With RV16
n=46 participants at risk
Volunteers challenged with RV16 to produce RV16 infected volunteers for subsequent arms
Human rhinovirus
|
RV16 Infected Volunteers Re-challenged With RV16
n=20 participants at risk
volunteers re-challenged with RV16
human rhinovirus: human rhinovirus
|
RV16 Infected Volunteers Re-challenged With RV39
n=22 participants at risk
volunteers re-challenged with RV39
human rhinovirus: human rhinovirus
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
bloody nose
|
0.00%
0/46 • Adverse events were collected at each study visit from the virus challenge/re-challenge to 15 weeks.
Adverse events were collected by interactive interview with study staff at each study visit between challenge/re-challenge and week 15. 46 subjects were initially challenged with RV16. 42 subjects were re-challenged with either RV16 or RV39. Three subjects voluntarily withdrew from the study before re-challenge and one subject had common cold symptoms on the scheduled day of the re-challenge and was removed from the study by the investigator.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at each study visit from the virus challenge/re-challenge to 15 weeks.
Adverse events were collected by interactive interview with study staff at each study visit between challenge/re-challenge and week 15. 46 subjects were initially challenged with RV16. 42 subjects were re-challenged with either RV16 or RV39. Three subjects voluntarily withdrew from the study before re-challenge and one subject had common cold symptoms on the scheduled day of the re-challenge and was removed from the study by the investigator.
|
0.00%
0/22 • Adverse events were collected at each study visit from the virus challenge/re-challenge to 15 weeks.
Adverse events were collected by interactive interview with study staff at each study visit between challenge/re-challenge and week 15. 46 subjects were initially challenged with RV16. 42 subjects were re-challenged with either RV16 or RV39. Three subjects voluntarily withdrew from the study before re-challenge and one subject had common cold symptoms on the scheduled day of the re-challenge and was removed from the study by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
2.2%
1/46 • Number of events 1 • Adverse events were collected at each study visit from the virus challenge/re-challenge to 15 weeks.
Adverse events were collected by interactive interview with study staff at each study visit between challenge/re-challenge and week 15. 46 subjects were initially challenged with RV16. 42 subjects were re-challenged with either RV16 or RV39. Three subjects voluntarily withdrew from the study before re-challenge and one subject had common cold symptoms on the scheduled day of the re-challenge and was removed from the study by the investigator.
|
0.00%
0/20 • Adverse events were collected at each study visit from the virus challenge/re-challenge to 15 weeks.
Adverse events were collected by interactive interview with study staff at each study visit between challenge/re-challenge and week 15. 46 subjects were initially challenged with RV16. 42 subjects were re-challenged with either RV16 or RV39. Three subjects voluntarily withdrew from the study before re-challenge and one subject had common cold symptoms on the scheduled day of the re-challenge and was removed from the study by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events were collected at each study visit from the virus challenge/re-challenge to 15 weeks.
Adverse events were collected by interactive interview with study staff at each study visit between challenge/re-challenge and week 15. 46 subjects were initially challenged with RV16. 42 subjects were re-challenged with either RV16 or RV39. Three subjects voluntarily withdrew from the study before re-challenge and one subject had common cold symptoms on the scheduled day of the re-challenge and was removed from the study by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Headache
|
2.2%
1/46 • Number of events 1 • Adverse events were collected at each study visit from the virus challenge/re-challenge to 15 weeks.
Adverse events were collected by interactive interview with study staff at each study visit between challenge/re-challenge and week 15. 46 subjects were initially challenged with RV16. 42 subjects were re-challenged with either RV16 or RV39. Three subjects voluntarily withdrew from the study before re-challenge and one subject had common cold symptoms on the scheduled day of the re-challenge and was removed from the study by the investigator.
|
0.00%
0/20 • Adverse events were collected at each study visit from the virus challenge/re-challenge to 15 weeks.
Adverse events were collected by interactive interview with study staff at each study visit between challenge/re-challenge and week 15. 46 subjects were initially challenged with RV16. 42 subjects were re-challenged with either RV16 or RV39. Three subjects voluntarily withdrew from the study before re-challenge and one subject had common cold symptoms on the scheduled day of the re-challenge and was removed from the study by the investigator.
|
0.00%
0/22 • Adverse events were collected at each study visit from the virus challenge/re-challenge to 15 weeks.
Adverse events were collected by interactive interview with study staff at each study visit between challenge/re-challenge and week 15. 46 subjects were initially challenged with RV16. 42 subjects were re-challenged with either RV16 or RV39. Three subjects voluntarily withdrew from the study before re-challenge and one subject had common cold symptoms on the scheduled day of the re-challenge and was removed from the study by the investigator.
|
Additional Information
Ronald Turner, MD
University of Virginia School of Medicine
Phone: 4349819964
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place