Trial Outcomes & Findings for Single-ascending-dose Study of the Safety and Immunogenicity of NasoVAX (NCT NCT03232567)
NCT ID: NCT03232567
Last Updated: 2024-04-30
Results Overview
Adverse events (AEs): counts and percentages of subjects with AEs Day 1 to day 29 and Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Day 1 to Day 181
Results posted on
2024-04-30
Participant Flow
Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age. Subjects were screened within 28 days of randomization.
60 subjects who met all inclusion and no exclusion criteria and provided written informed consent were enrolled into 3 sequential cohorts of 20 subjects each defined by the vaccine dose (1×10\^9, 1×10\^10,1×10\^11 vp). Within each cohort and its sentinel group, subjects were randomized in a 3:1 ratio to receive 1 intranasal dose of NasoVAX or placebo
Participant milestones
| Measure |
NasoVAX Low Dose
NasoVAX administered by intranasal spray at a single dose of 1×10\^9 viral particles (vp)
|
NasoVAX Medium Dose
NasoVAX administered by intranasal spray at a single dose of 1×10\^10 viral particles (vp)
|
NasoVAX High Dose
NasoVAX administered by intranasal spray at a single dose of 1×10\^11 viral particles (vp)
|
Placebo
Normal saline administered by intranasal spray at a single dose
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
14
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
NasoVAX Low Dose
NasoVAX administered by intranasal spray at a single dose of 1×10\^9 viral particles (vp)
|
NasoVAX Medium Dose
NasoVAX administered by intranasal spray at a single dose of 1×10\^10 viral particles (vp)
|
NasoVAX High Dose
NasoVAX administered by intranasal spray at a single dose of 1×10\^11 viral particles (vp)
|
Placebo
Normal saline administered by intranasal spray at a single dose
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Single-ascending-dose Study of the Safety and Immunogenicity of NasoVAX
Baseline characteristics by cohort
| Measure |
NasoVAX Low Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^9viral particles (vp)
|
NasoVAX Medium Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^10 viral particles (vp)
|
NasoVAX High Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^11 viral particles (vp)
|
Placebo
n=15 Participants
Normal saline administered by intranasal spray at a single dose
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
Age · <=18 years
|
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, Categorical
Age · Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Age, Categorical
Age · >=65 years
|
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, Continuous
|
30.1 years
n=5 Participants
|
31.6 years
n=7 Participants
|
32.6 years
n=5 Participants
|
29.3 years
n=4 Participants
|
30.9 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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)
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
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 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
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 181Population: All ALT-103-201 and ALT-FLZ-401 subjects who provide informed consent, are randomized, and receive at least 1 vaccination. The Safety Population will be used for all safety analyses and will be analyzed according to the treatment received.
Adverse events (AEs): counts and percentages of subjects with AEs Day 1 to day 29 and Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
Outcome measures
| Measure |
NasoVAX Low Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^9 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX Medium Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^10 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX High Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^11 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
Placebo
n=15 Participants
Normal saline administered by intranasal spray at a single dose
|
|---|---|---|---|---|
|
Number of Treatment-Emergent Adverse Events in Participants [Safety and Tolerability]
Any TEAE
|
10 Participants
|
10 Participants
|
10 Participants
|
15 Participants
|
|
Number of Treatment-Emergent Adverse Events in Participants [Safety and Tolerability]
Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Treatment-Emergent Adverse Events in Participants [Safety and Tolerability]
IP Related TEAE
|
2 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Number of Treatment-Emergent Adverse Events in Participants [Safety and Tolerability]
IP Related SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Treatment-Emergent Adverse Events in Participants [Safety and Tolerability]
Grade 3 or 4 TEAE
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Treatment-Emergent Adverse Events in Participants [Safety and Tolerability]
TEAE Leading to Withdrawal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 14-days after vaccinationPopulation: All ALT-103-201 and ALT-FLZ-401 subjects who provide informed consent, are randomized, and receive at least 1 vaccination. The Safety Population will be used for all safety analyses and will be analyzed according to the treatment received.
Reactogenicity: counts and percentages of subjects with 'yes' to any reactogenicity event (nasal irritation, sneezing, nasal congestion, sore throat, change in smell, change in taste, change in vision, eye pain, headache, fatigue, muscle ache, nausea, vomiting, diarrhea, chills, fever)
Outcome measures
| Measure |
NasoVAX Low Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^9 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX Medium Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^10 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX High Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^11 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
Placebo
n=15 Participants
Normal saline administered by intranasal spray at a single dose
|
|---|---|---|---|---|
|
Number of Treatment-Emergent Reactogenicity Events in Participants [Safety and Tolerability]
Any local event
|
9 Participants
|
9 Participants
|
6 Participants
|
6 Participants
|
|
Number of Treatment-Emergent Reactogenicity Events in Participants [Safety and Tolerability]
Any systemic event
|
9 Participants
|
11 Participants
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: Per-protocol population: All subjects who received the assigned dose of the test article, had HAI assay results on Days 1 and 29, and had no major protocol deviations affecting the primary immunogenicity outcomes.
The antilog of the mean of the log-transformed antibody titers for humoral immune response to NasoVAX at Day 29 by HAI
Outcome measures
| Measure |
NasoVAX Low Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^9 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX Medium Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^10 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX High Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^11 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
Placebo
n=15 Participants
Normal saline administered by intranasal spray at a single dose
|
|---|---|---|---|---|
|
Geometric Mean Antibody Level Measured by Hemagglutination Inhibition (HAI) in Serum
|
87.2 Titer
Interval 52.7 to 144.3
|
136.1 Titer
Interval 81.7 to 226.6
|
164.0 Titer
Interval 99.0 to 271.6
|
31.3 Titer
Interval 18.9 to 52.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: Per-protocol population
The ratio of postvaccination and prevaccination geometric mean titers within the same dose group for humoral immune response to NasoVAX at Day 29 by HAI
Outcome measures
| Measure |
NasoVAX Low Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^9 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX Medium Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^10 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX High Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^11 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
Placebo
n=15 Participants
Normal saline administered by intranasal spray at a single dose
|
|---|---|---|---|---|
|
Geometric Mean Ratio of Postvaccination and Prevaccination Antibody Level Measured by Hemagglutination Inhibition (HAI) in Serum
|
2.1 Ratio
Interval 1.1 to 4.2
|
2.2 Ratio
Interval 1.2 to 4.3
|
4.3 Ratio
Interval 1.5 to 12.0
|
0.9 Ratio
Interval 0.7 to 1.2
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: Per-protocol population
The percentage of subjects with an HAI titer greater than or equal to 1:40
Outcome measures
| Measure |
NasoVAX Low Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^9 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX Medium Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^10 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX High Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^11 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
Placebo
n=15 Participants
Normal saline administered by intranasal spray at a single dose
|
|---|---|---|---|---|
|
Seroprotection Rate
|
80.0 percentage of participants
Interval 51.9 to 95.7
|
100 percentage of participants
Interval 78.2 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
53.3 percentage of participants
Interval 26.6 to 78.7
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: Per-protocol population
The percentage of subjects with either a baseline HAI titer less than 1:10 and a postvaccination titer greater than or equal to 1:40 or a baseline HAI titer greater than or equal to 1:10 and a 4-fold increase in postvaccination HAI titer relative to baseline
Outcome measures
| Measure |
NasoVAX Low Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^9 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX Medium Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^10 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX High Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^11 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
Placebo
n=15 Participants
Normal saline administered by intranasal spray at a single dose
|
|---|---|---|---|---|
|
Seroconversion Rate
|
13.3 percentage of participants
Interval 1.7 to 40.5
|
26.7 percentage of participants
Interval 7.8 to 55.1
|
33.3 percentage of participants
Interval 11.8 to 61.6
|
0.0 percentage of participants
Interval 0.0 to 21.8
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: Per-protocol population: All subjects who received the assigned dose of the test article, had HAI assay results on Days 1 and 29, and had no major protocol deviations affecting the primary immunogenicity outcomes.
Geometric mean titer (GMT) for humoral immune response to NasoVAX at Day 29 by microneutralization
Outcome measures
| Measure |
NasoVAX Low Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^9 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX Medium Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^10 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX High Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^11 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
Placebo
n=15 Participants
Normal saline administered by intranasal spray at a single dose
|
|---|---|---|---|---|
|
Antibody Level Measured by Microneutralization in Serum
|
44.9 Titer
Interval 21.8 to 92.3
|
113.1 Titer
Interval 58.0 to 220.8
|
142.5 Titer
Interval 93.6 to 217.1
|
17.8 Titer
Interval 9.1 to 35.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: Per-protocol population
The percentages of subjects with 2-fold and 4-fold rises from baseline in antibody level measured by microneutralization
Outcome measures
| Measure |
NasoVAX Low Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^9 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX Medium Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^10 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX High Dose
n=15 Participants
NasoVAX administered by intranasal spray at a single dose of 1×10\^11 viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
Placebo
n=15 Participants
Normal saline administered by intranasal spray at a single dose
|
|---|---|---|---|---|
|
Antibody Responder Rate by Microneutralization
Percentage of subjects with 2-fold rise
|
40.0 percentage of participants
Interval 16.3 to 67.7
|
46.7 percentage of participants
Interval 21.3 to 73.4
|
73.3 percentage of participants
Interval 44.9 to 92.2
|
0.0 percentage of participants
Interval 0.0 to 21.8
|
|
Antibody Responder Rate by Microneutralization
Percentage of subjects with 4-fold rise
|
13.3 percentage of participants
Interval 1.7 to 40.5
|
26.7 percentage of participants
Interval 7.8 to 55.1
|
53.3 percentage of participants
Interval 26.6 to 78.7
|
0.0 percentage of participants
Interval 0.0 to 21.8
|
Adverse Events
NasoVAX Low Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
NasoVAX Medium Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
NasoVAX High Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NasoVAX Low Dose
n=15 participants at risk
NasoVAX administered by intranasal spray at a single dose of 1×10(9th) viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX Medium Dose
n=15 participants at risk
NasoVAX administered by intranasal spray at a single dose of 1×10(10th) viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
NasoVAX High Dose
n=15 participants at risk
NasoVAX administered by intranasal spray at a single dose of 1×10(11th) viral particles (vp) versus placebo
NasoVAX: Single ascending dose study
|
Placebo
n=15 participants at risk
Normal saline administered
|
|---|---|---|---|---|
|
Product Issues
Any treatment emergent adverse event
|
66.7%
10/15 • AEs Day 1 to day 29 Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
Adverse events (AEs): counts and percentages of subjects with AEs Day 1 to day 29 and Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
|
66.7%
10/15 • AEs Day 1 to day 29 Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
Adverse events (AEs): counts and percentages of subjects with AEs Day 1 to day 29 and Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
|
66.7%
10/15 • AEs Day 1 to day 29 Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
Adverse events (AEs): counts and percentages of subjects with AEs Day 1 to day 29 and Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
|
100.0%
15/15 • AEs Day 1 to day 29 Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
Adverse events (AEs): counts and percentages of subjects with AEs Day 1 to day 29 and Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place