Trial Outcomes & Findings for Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children (NCT NCT05116241)
NCT ID: NCT05116241
Last Updated: 2025-11-06
Results Overview
Geometric mean fold rise (GMFR) of mucosal S-IgA against whole cell extract (WCE) by treatment arm (BPZE1, BPZE1 + Boostrix) at Day 29.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
368 participants
Primary outcome timeframe
Day 29
Results posted on
2025-11-06
Participant Flow
381 participants screened; 368 participants randomized (2 participants randomized but not vaccinated); 366 participants vaccinated. Participants were grouped by age: 6-10 years and 11-17 years with a Safety Lead-in group of 45 participants in the older age group. All participants were in the study from 11-Nov-2021 through 15-May-2024 Period 1 (Day 1): Vaccination; Period 2 (Day 85): Optional Attenuated Challenge Substudy
Participant milestones
| Measure |
BPZE1 and Intramuscular Placebo
Day 1: Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo.
|
BPZE1 and Boostrix Intramuscular
Day 1: Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine).
|
Placebo Intranasal and Boostrix Intramuscular
Day 1: Participants received an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator).
|
|---|---|---|---|
|
Study
STARTED
|
123
|
121
|
122
|
|
Study
COMPLETED
|
118
|
117
|
119
|
|
Study
NOT COMPLETED
|
5
|
4
|
3
|
|
Optional Attenuated Challenge Substudy
STARTED
|
38
|
36
|
46
|
|
Optional Attenuated Challenge Substudy
COMPLETED
|
38
|
36
|
46
|
|
Optional Attenuated Challenge Substudy
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
BPZE1 and Intramuscular Placebo
Day 1: Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo.
|
BPZE1 and Boostrix Intramuscular
Day 1: Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine).
|
Placebo Intranasal and Boostrix Intramuscular
Day 1: Participants received an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator).
|
|---|---|---|---|
|
Study
Withdrawal by Subject
|
5
|
2
|
1
|
|
Study
Lost to Follow-up
|
0
|
2
|
2
|
Baseline Characteristics
Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children
Baseline characteristics by cohort
| Measure |
BPZE1 and Boostrix Intramuscular
n=121 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine).
|
Placebo Intranasal and Boostrix Intramuscular
n=122 Participants
Participants received an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator).
|
Total
n=366 Participants
Total of all reporting groups
|
BPZE1 and Intramuscular Placebo
n=123 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo.
|
|---|---|---|---|---|
|
Age, Continuous
|
10.8 years
STANDARD_DEVIATION 2.9 • n=50 Participants
|
10.7 years
STANDARD_DEVIATION 2.8 • n=50 Participants
|
10.8 years
STANDARD_DEVIATION 2.8 • n=50 Participants
|
10.9 years
STANDARD_DEVIATION 2.7 • n=49 Participants
|
|
Age, Customized
6-10 years
|
67 Participants
n=50 Participants
|
65 Participants
n=50 Participants
|
192 Participants
n=50 Participants
|
60 Participants
n=49 Participants
|
|
Age, Customized
11-17 years
|
54 Participants
n=50 Participants
|
57 Participants
n=50 Participants
|
174 Participants
n=50 Participants
|
63 Participants
n=49 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=50 Participants
|
54 Participants
n=50 Participants
|
170 Participants
n=50 Participants
|
60 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=50 Participants
|
68 Participants
n=50 Participants
|
196 Participants
n=50 Participants
|
63 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
58 Participants
n=50 Participants
|
58 Participants
n=50 Participants
|
176 Participants
n=50 Participants
|
60 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
63 Participants
n=50 Participants
|
64 Participants
n=50 Participants
|
190 Participants
n=50 Participants
|
63 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
White
|
52 Participants
n=50 Participants
|
55 Participants
n=50 Participants
|
161 Participants
n=50 Participants
|
54 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
9 Participants
n=50 Participants
|
3 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Aboriginal or Torres Strait Islander
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Mixed or Multiple Ethnic Group
|
4 Participants
n=50 Participants
|
10 Participants
n=50 Participants
|
20 Participants
n=50 Participants
|
6 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
59 Participants
n=50 Participants
|
57 Participants
n=50 Participants
|
176 Participants
n=50 Participants
|
60 Participants
n=49 Participants
|
|
Region of Enrollment
United Kingdom
|
23 participants
n=50 Participants
|
22 participants
n=50 Participants
|
68 participants
n=50 Participants
|
23 participants
n=49 Participants
|
|
Region of Enrollment
Australia
|
23 participants
n=50 Participants
|
27 participants
n=50 Participants
|
77 participants
n=50 Participants
|
27 participants
n=49 Participants
|
|
Region of Enrollment
Costa Rica
|
75 participants
n=50 Participants
|
73 participants
n=50 Participants
|
221 participants
n=50 Participants
|
73 participants
n=49 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: Per protocol immunogenicity analysis set
Geometric mean fold rise (GMFR) of mucosal S-IgA against whole cell extract (WCE) by treatment arm (BPZE1, BPZE1 + Boostrix) at Day 29.
Outcome measures
| Measure |
Placebo Intranasal and Boostrix Intramuscular
n=111 Participants
Participants received an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator).
|
BPZE1 and Intramuscular Placebo
n=105 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo.
|
BPZE1 and Boostrix Intramuscular
n=113 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine).
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Mucosal Immunogenicity S-IgA Against Whole Cell Extract at Day 29
|
1.2 Fold Rise
Interval 1.0 to 1.5
|
3.8 Fold Rise
Interval 3.1 to 4.7
|
3.5 Fold Rise
Interval 2.9 to 4.3
|
PRIMARY outcome
Timeframe: Through 7 days following first study vaccination.Population: Safety analysis set
Solicited AEs (local injection site, nasal/respiratory, and systemic reactogenicity events)
Outcome measures
| Measure |
Placebo Intranasal and Boostrix Intramuscular
n=122 Participants
Participants received an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator).
|
BPZE1 and Intramuscular Placebo
n=123 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo.
|
BPZE1 and Boostrix Intramuscular
n=121 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine).
|
|---|---|---|---|
|
Safety: Solicited Adverse Events (AEs)
Systemic reactogenicity
|
67 Participants
|
51 Participants
|
60 Participants
|
|
Safety: Solicited Adverse Events (AEs)
Nasal/Respiratory reactogenicity
|
55 Participants
|
61 Participants
|
63 Participants
|
|
Safety: Solicited Adverse Events (AEs)
Local injection site reactogenicity
|
88 Participants
|
59 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: Day 29Population: Per protocol immunogenicity analysis set
Serum IgG levels against diphtheria, tetanus by treatment groups (BPZE1 + Boostrix vs Boostrix)
Outcome measures
| Measure |
Placebo Intranasal and Boostrix Intramuscular
Participants received an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator).
|
BPZE1 and Intramuscular Placebo
n=111 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo.
|
BPZE1 and Boostrix Intramuscular
n=109 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine).
|
|---|---|---|---|
|
Serum IgG: Proportion of Subjects With Antibody Concentration ≥0.1 Immunogenicity Serum IgG for Diphtheria, Tetanus
Serum IgG against Diphtheria >= 0.1 IU/ml
|
—
|
111 Participants
|
109 Participants
|
|
Serum IgG: Proportion of Subjects With Antibody Concentration ≥0.1 Immunogenicity Serum IgG for Diphtheria, Tetanus
Serum IgG against Tetanus >= 0.1 IU/ml
|
—
|
111 Participants
|
109 Participants
|
SECONDARY outcome
Timeframe: Day 29Population: Per protocol immunogenicity analysis set
Serum IgG levels against acellular pertussis antigens (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\]) by treatment groups (BPZE1 + Boostrix vs Boostrix)
Outcome measures
| Measure |
Placebo Intranasal and Boostrix Intramuscular
Participants received an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator).
|
BPZE1 and Intramuscular Placebo
n=111 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo.
|
BPZE1 and Boostrix Intramuscular
n=109 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine).
|
|---|---|---|---|
|
Serum IgG: Geometric Mean Concentration (GMC) Against Acellular Pertussis Antigens
Serum IgG against PRN
|
—
|
116.2 IU/ml
Interval 86.9 to 155.4
|
82.5 IU/ml
Interval 57.2 to 118.9
|
|
Serum IgG: Geometric Mean Concentration (GMC) Against Acellular Pertussis Antigens
Serum IgG against FHA
|
—
|
502.9 IU/ml
Interval 443.3 to 570.5
|
458.2 IU/ml
Interval 399.8 to 525.1
|
|
Serum IgG: Geometric Mean Concentration (GMC) Against Acellular Pertussis Antigens
Serum IgG against PT
|
—
|
88.1 IU/ml
Interval 76.4 to 101.6
|
84.4 IU/ml
Interval 71.9 to 99.0
|
SECONDARY outcome
Timeframe: Baseline, Day 29Population: Per protocol immunogenicity analysis set
Induction of normalized S-IgA against WCE, PT, FHA, PRN, and any additional anti-pertussis mucosal antibodies identified during assay development (fimbriae serotype 2 and 3; FIM 2/3) using GMR
Outcome measures
| Measure |
Placebo Intranasal and Boostrix Intramuscular
n=111 Participants
Participants received an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator).
|
BPZE1 and Intramuscular Placebo
n=105 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo.
|
BPZE1 and Boostrix Intramuscular
n=113 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine).
|
|---|---|---|---|
|
Mucosal Immunogenicity S-IgA GMR
Baseline WCE
|
22.4 AU/(mg S-IgA)
Interval 19.3 to 26.0
|
27.2 AU/(mg S-IgA)
Interval 23.8 to 30.9
|
24.8 AU/(mg S-IgA)
Interval 21.8 to 28.2
|
|
Mucosal Immunogenicity S-IgA GMR
Baseline PT
|
3.5 AU/(mg S-IgA)
Interval 3.1 to 4.0
|
4.0 AU/(mg S-IgA)
Interval 3.6 to 4.6
|
3.8 AU/(mg S-IgA)
Interval 3.3 to 4.4
|
|
Mucosal Immunogenicity S-IgA GMR
Baseline PRN
|
2.7 AU/(mg S-IgA)
Interval 2.3 to 3.1
|
3.0 AU/(mg S-IgA)
Interval 2.6 to 3.6
|
3.3 AU/(mg S-IgA)
Interval 2.8 to 3.8
|
|
Mucosal Immunogenicity S-IgA GMR
Baseline FHA
|
2.2 AU/(mg S-IgA)
Interval 1.9 to 2.7
|
2.3 AU/(mg S-IgA)
Interval 2.0 to 2.7
|
2.3 AU/(mg S-IgA)
Interval 1.9 to 2.7
|
|
Mucosal Immunogenicity S-IgA GMR
Baseline FIM 2/3
|
2.3 AU/(mg S-IgA)
Interval 1.9 to 2.8
|
3.0 AU/(mg S-IgA)
Interval 2.4 to 3.7
|
2.6 AU/(mg S-IgA)
Interval 2.2 to 3.0
|
|
Mucosal Immunogenicity S-IgA GMR
Day 29 WCE
|
27.4 AU/(mg S-IgA)
Interval 23.6 to 31.7
|
104.0 AU/(mg S-IgA)
Interval 86.2 to 125.5
|
86.3 AU/(mg S-IgA)
Interval 72.8 to 102.4
|
|
Mucosal Immunogenicity S-IgA GMR
Day 29 PT
|
4.3 AU/(mg S-IgA)
Interval 3.8 to 4.9
|
6.8 AU/(mg S-IgA)
Interval 5.8 to 7.8
|
6.5 AU/(mg S-IgA)
Interval 5.7 to 7.4
|
|
Mucosal Immunogenicity S-IgA GMR
Day 29 PRN
|
4.0 AU/(mg S-IgA)
Interval 3.4 to 4.6
|
11.4 AU/(mg S-IgA)
Interval 9.3 to 14.1
|
13.6 AU/(mg S-IgA)
Interval 11.1 to 16.7
|
|
Mucosal Immunogenicity S-IgA GMR
Day 29 FHA
|
4.7 AU/(mg S-IgA)
Interval 3.9 to 5.7
|
18.6 AU/(mg S-IgA)
Interval 14.6 to 23.6
|
15.7 AU/(mg S-IgA)
Interval 12.8 to 19.2
|
|
Mucosal Immunogenicity S-IgA GMR
Day 29 FIM 2/3
|
3.0 AU/(mg S-IgA)
Interval 2.5 to 3.7
|
42.4 AU/(mg S-IgA)
Interval 30.6 to 58.6
|
26.9 AU/(mg S-IgA)
Interval 19.6 to 36.9
|
SECONDARY outcome
Timeframe: Day 29Population: Per protocol immunogenicity analysis set
Induction of normalized S-IgA against WCE, FHA, PRN, and any additional anti-pertussis mucosal antibodies identified during assay development (FIM 2/3) using GMFR
Outcome measures
| Measure |
Placebo Intranasal and Boostrix Intramuscular
n=111 Participants
Participants received an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator).
|
BPZE1 and Intramuscular Placebo
n=105 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo.
|
BPZE1 and Boostrix Intramuscular
n=113 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine).
|
|---|---|---|---|
|
Mucosal Immunogenicity S-IgA GMFR
Day 29 WCE
|
1.2 Fold Rise
Interval 1.0 to 1.5
|
3.8 Fold Rise
Interval 3.1 to 4.7
|
3.5 Fold Rise
Interval 2.9 to 4.3
|
|
Mucosal Immunogenicity S-IgA GMFR
Day 29 PT
|
1.2 Fold Rise
Interval 1.1 to 1.4
|
1.7 Fold Rise
Interval 1.4 to 1.9
|
1.7 Fold Rise
Interval 1.5 to 2.0
|
|
Mucosal Immunogenicity S-IgA GMFR
Day 29 PRN
|
1.5 Fold Rise
Interval 1.3 to 1.8
|
3.7 Fold Rise
Interval 2.9 to 4.7
|
4.2 Fold Rise
Interval 3.3 to 5.2
|
|
Mucosal Immunogenicity S-IgA GMFR
Day 29 FHA
|
2.1 Fold Rise
Interval 1.8 to 2.6
|
8.1 Fold Rise
Interval 6.1 to 10.8
|
6.8 Fold Rise
Interval 5.4 to 8.7
|
|
Mucosal Immunogenicity S-IgA GMFR
Day 29 FIM 2/3
|
1.3 Fold Rise
Interval 1.2 to 1.5
|
14.0 Fold Rise
Interval 9.6 to 20.5
|
10.5 Fold Rise
Interval 7.5 to 14.7
|
SECONDARY outcome
Timeframe: Baseline, Day 29Population: Per protocol immunogenicity analysis set
Induction of serum immunity (IgA and IgG) against WCE, pertussis toxin (PT), FHA, PRN, and any additional anti-pertussis antibodies identified during assay development (FIM 2/3) using GMC
Outcome measures
| Measure |
Placebo Intranasal and Boostrix Intramuscular
n=109 Participants
Participants received an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator).
|
BPZE1 and Intramuscular Placebo
n=106 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo.
|
BPZE1 and Boostrix Intramuscular
n=111 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine).
|
|---|---|---|---|
|
Serum Immunogenicity IgA and IgG GMC
IgG Baseline WCE
|
51.5 IU/ml
Interval 43.2 to 61.2
|
42.4 IU/ml
Interval 35.1 to 51.3
|
52.5 IU/ml
Interval 43.4 to 63.4
|
|
Serum Immunogenicity IgA and IgG GMC
IgG Baseline PT
|
9.1 IU/ml
Interval 7.5 to 10.9
|
7.8 IU/ml
Interval 6.6 to 9.3
|
8.5 IU/ml
Interval 7.2 to 10.1
|
|
Serum Immunogenicity IgA and IgG GMC
IgG Baseline PRN
|
8.4 IU/ml
Interval 6.6 to 10.7
|
7.6 IU/ml
Interval 5.9 to 9.7
|
8.5 IU/ml
Interval 6.6 to 10.8
|
|
Serum Immunogenicity IgA and IgG GMC
IgG Baseline FHA
|
46.2 IU/ml
Interval 37.3 to 57.2
|
31.3 IU/ml
Interval 26.8 to 36.5
|
42.9 IU/ml
Interval 35.9 to 51.1
|
|
Serum Immunogenicity IgA and IgG GMC
IgG Baseline FIM 2/3
|
13.3 IU/ml
Interval 10.0 to 17.9
|
14.3 IU/ml
Interval 10.6 to 19.3
|
12.9 IU/ml
Interval 10.0 to 16.8
|
|
Serum Immunogenicity IgA and IgG GMC
IgG Day 29 WCE
|
164.9 IU/ml
Interval 142.9 to 190.1
|
111.4 IU/ml
Interval 93.4 to 132.9
|
229.2 IU/ml
Interval 196.0 to 267.9
|
|
Serum Immunogenicity IgA and IgG GMC
IgG Day 29 PT
|
84.4 IU/ml
Interval 71.9 to 99.0
|
31.3 IU/ml
Interval 24.8 to 39.6
|
88.1 IU/ml
Interval 76.4 to 101.6
|
|
Serum Immunogenicity IgA and IgG GMC
IgG Day 29 PRN
|
82.5 IU/ml
Interval 57.2 to 118.9
|
29.3 IU/ml
Interval 23.5 to 36.6
|
116.2 IU/ml
Interval 86.9 to 155.4
|
|
Serum Immunogenicity IgA and IgG GMC
IgG Day 29 FHA
|
458.2 IU/ml
Interval 399.8 to 525.1
|
130.8 IU/ml
Interval 107.3 to 159.4
|
502.9 IU/ml
Interval 443.3 to 570.5
|
|
Serum Immunogenicity IgA and IgG GMC
IgG Day 29 FIM 2/3
|
21.5 IU/ml
Interval 15.5 to 29.8
|
107.1 IU/ml
Interval 80.8 to 141.8
|
80.2 IU/ml
Interval 61.7 to 104.4
|
|
Serum Immunogenicity IgA and IgG GMC
IgA Baseline WCE
|
14.7 IU/ml
Interval 12.4 to 17.4
|
12.3 IU/ml
Interval 10.9 to 13.8
|
14.7 IU/ml
Interval 12.7 to 17.0
|
|
Serum Immunogenicity IgA and IgG GMC
IgA Baseline PT
|
1.7 IU/ml
Interval 1.4 to 2.0
|
1.5 IU/ml
Interval 1.3 to 1.6
|
1.6 IU/ml
Interval 1.4 to 1.8
|
|
Serum Immunogenicity IgA and IgG GMC
IgA Baseline PRN
|
1.7 IU/ml
Interval 1.4 to 2.2
|
1.5 IU/ml
Interval 1.3 to 1.8
|
1.9 IU/ml
Interval 1.5 to 2.3
|
|
Serum Immunogenicity IgA and IgG GMC
IgA Baseline FHA
|
3.3 IU/ml
Interval 2.5 to 4.3
|
2.2 IU/ml
Interval 1.8 to 2.7
|
2.8 IU/ml
Interval 2.2 to 3.5
|
|
Serum Immunogenicity IgA and IgG GMC
IgA Baseline FIM 2/3
|
3.3 IU/ml
Interval 2.6 to 4.2
|
2.9 IU/ml
Interval 2.3 to 3.7
|
2.9 IU/ml
Interval 2.3 to 3.6
|
|
Serum Immunogenicity IgA and IgG GMC
IgA Day 29 WCE
|
25.7 IU/ml
Interval 21.3 to 31.1
|
53.0 IU/ml
Interval 44.0 to 63.8
|
56.6 IU/ml
Interval 47.3 to 67.6
|
|
Serum Immunogenicity IgA and IgG GMC
IgA Day 29 PT
|
2.6 IU/ml
Interval 2.2 to 3.0
|
4.3 IU/ml
Interval 3.5 to 5.3
|
4.4 IU/ml
Interval 3.7 to 5.2
|
|
Serum Immunogenicity IgA and IgG GMC
IgA Day 29 PRN
|
6.9 IU/ml
Interval 5.0 to 9.6
|
10.8 IU/ml
Interval 8.4 to 13.8
|
25.0 IU/ml
Interval 18.6 to 33.5
|
|
Serum Immunogenicity IgA and IgG GMC
IgA Day 29 FHA
|
21.1 IU/ml
Interval 16.6 to 27.0
|
20.0 IU/ml
Interval 15.6 to 25.7
|
33.6 IU/ml
Interval 27.3 to 41.3
|
|
Serum Immunogenicity IgA and IgG GMC
IgA Day 29 FIM 2/3
|
4.5 IU/ml
Interval 3.4 to 6.0
|
45.2 IU/ml
Interval 33.0 to 61.7
|
31.1 IU/ml
Interval 22.2 to 43.7
|
SECONDARY outcome
Timeframe: Baseline, Day 29Population: Per protocol immunogenicity analysis set
Induction of serum immunity (IgA and IgG) against WCE, pertussis toxin (PT), FHA, PRN, and any additional anti-pertussis antibodies identified during assay development (FIM 2/3) using GMFR
Outcome measures
| Measure |
Placebo Intranasal and Boostrix Intramuscular
n=109 Participants
Participants received an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator).
|
BPZE1 and Intramuscular Placebo
n=106 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo.
|
BPZE1 and Boostrix Intramuscular
n=111 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine).
|
|---|---|---|---|
|
Serum Immunogenicity IgA and IgG GMFR
IgG Day 29 WCE
|
3.3 Fold Rise
Interval 2.8 to 3.8
|
2.6 Fold Rise
Interval 2.2 to 3.0
|
4.4 Fold Rise
Interval 3.8 to 5.2
|
|
Serum Immunogenicity IgA and IgG GMFR
IgG Day 29 PT
|
9.3 Fold Rise
Interval 7.8 to 10.9
|
4.0 Fold Rise
Interval 3.1 to 5.1
|
10.4 Fold Rise
Interval 9.2 to 11.8
|
|
Serum Immunogenicity IgA and IgG GMFR
IgG Day 29 PRN
|
9.6 Fold Rise
Interval 7.4 to 12.4
|
3.8 Fold Rise
Interval 3.0 to 4.8
|
14.5 Fold Rise
Interval 11.3 to 18.6
|
|
Serum Immunogenicity IgA and IgG GMFR
IgG Day 29 FHA
|
9.9 Fold Rise
Interval 8.1 to 12.2
|
4.2 Fold Rise
Interval 3.3 to 5.3
|
11.9 Fold Rise
Interval 10.0 to 14.3
|
|
Serum Immunogenicity IgA and IgG GMFR
IgG Day 29 FIM 2/3
|
1.7 Fold Rise
Interval 1.4 to 1.9
|
7.4 Fold Rise
Interval 5.6 to 9.9
|
6.4 Fold Rise
Interval 4.9 to 8.3
|
|
Serum Immunogenicity IgA and IgG GMFR
IgA Day 29 WCE
|
1.7 Fold Rise
Interval 1.5 to 2.1
|
4.2 Fold Rise
Interval 3.5 to 5.2
|
3.9 Fold Rise
Interval 3.3 to 4.7
|
|
Serum Immunogenicity IgA and IgG GMFR
IgA Day 29 PT
|
1.6 Fold Rise
Interval 1.4 to 1.8
|
2.9 Fold Rise
Interval 2.4 to 3.6
|
2.7 Fold Rise
Interval 2.4 to 3.1
|
|
Serum Immunogenicity IgA and IgG GMFR
IgA Day 29 PRN
|
4.1 Fold Rise
Interval 3.2 to 5.2
|
6.7 Fold Rise
Interval 5.4 to 9.1
|
13.9 Fold Rise
Interval 10.8 to 17.8
|
|
Serum Immunogenicity IgA and IgG GMFR
IgA Day 29 FHA
|
6.7 Fold Rise
Interval 5.2 to 8.5
|
9.0 Fold Rise
Interval 6.7 to 11.9
|
12.3 Fold Rise
Interval 10.0 to 15.1
|
|
Serum Immunogenicity IgA and IgG GMFR
IgA Day 29 FIM 2/3
|
1.4 Fold Rise
Interval 1.2 to 1.6
|
15.4 Fold Rise
Interval 11.1 to 21.4
|
10.9 Fold Rise
Interval 7.7 to 15.3
|
SECONDARY outcome
Timeframe: Through 7 days, 28 days, and 169 days (EOS) following any study vaccination respectivelyPopulation: Safety Analysis Set for Day 1 includes all vaccinated participants. Safety Analysis Set for Day 85 includes all Attenuated Challenge Open-label BPZE1 Substudy participants.
To describe reactogenicity events during the 7 days following any study vaccination (7 days after Day 1 study vaccination and 7 days after Day 85 attenuated challenge with open-label BPZE1), all AEs through 28 days following Day 1 study vaccination and Day 85 attenuated challenge with open-label BPZE1, medically-attended AEs (MAAE) through 84 days following Day 1 study vaccination and Day 85 attenuated challenge with open-label BPZE1, AEs of special interest (AESIs) and serious adverse events (SAE) through Day 169 (EOS).
Outcome measures
| Measure |
Placebo Intranasal and Boostrix Intramuscular
n=122 Participants
Participants received an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator).
|
BPZE1 and Intramuscular Placebo
n=123 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo.
|
BPZE1 and Boostrix Intramuscular
n=121 Participants
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine).
|
|---|---|---|---|
|
Safety: Reactogenicity and AEs
Reactogenicity after Day 1 study vaccination : Local injection site
|
88 Participants
|
59 Participants
|
81 Participants
|
|
Safety: Reactogenicity and AEs
Reactogenicity after Day 1 study vaccination : Nasal/Respiratory
|
55 Participants
|
61 Participants
|
63 Participants
|
|
Safety: Reactogenicity and AEs
Reactogenicity after Day 1 study vaccination : Systemic
|
67 Participants
|
51 Participants
|
60 Participants
|
|
Safety: Reactogenicity and AEs
Reactogenicity after Day 85 attenuated challenge with open-label BPZE1 : Nasal/Respiratory
|
24 Participants
|
19 Participants
|
16 Participants
|
|
Safety: Reactogenicity and AEs
MAAEs
|
23 Participants
|
25 Participants
|
12 Participants
|
|
Safety: Reactogenicity and AEs
Reactogenicity after Day 85 attenuated challenge with open-label BPZE1 : Systemic
|
22 Participants
|
19 Participants
|
14 Participants
|
|
Safety: Reactogenicity and AEs
Day 29 AEs
|
26 Participants
|
31 Participants
|
19 Participants
|
|
Safety: Reactogenicity and AEs
Day 85 AEs
|
10 Participants
|
4 Participants
|
10 Participants
|
|
Safety: Reactogenicity and AEs
SAEs
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Safety: Reactogenicity and AEs
AESI
|
3 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 92 or Day 99.Population: Investigational quantitative PCR not sensitive, no cultures performed and no results available.
Proportion of subjects with positive B. pertussis by culture or polymerase chain reaction \[PCR\]) following re-vaccination/attenuated challenge (BPZE1, BPZE1 + Boostrix, BPZE1 and BPZE1 + Boostrix, Boostrix control)
Outcome measures
Outcome data not reported
Adverse Events
BPZE1 and Intramuscular Placebo (All Participants Post-vaccination)
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
BPZE1 and Boostrix Intramuscular (All Participants Post-vaccination)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo Intranasal and Boostrix Intramuscular (All Participants Post-vaccination)
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
BPZE1 and Intramuscular Placebo (Optional Sub-study Participants Post-challenge)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BPZE1 and Boostrix Intramuscular (Optional Sub-study Participants Post-challenge)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Intranasal and Boostrix Intramuscular (Optional Sub-study Participants Post-challenge)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BPZE1 and Intramuscular Placebo (All Participants Post-vaccination)
n=123 participants at risk
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo (including all participants, those who participated in the optional substudy and those who did not participate in the optional substudy).
|
BPZE1 and Boostrix Intramuscular (All Participants Post-vaccination)
n=121 participants at risk
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine) (including all participants, those who participated in the optional substudy and those who did not participate in the optional substudy).
|
Placebo Intranasal and Boostrix Intramuscular (All Participants Post-vaccination)
n=122 participants at risk
Participants received an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator) (including all participants, those who participated in the optional substudy and those who did not participate in the optional substudy).
|
BPZE1 and Intramuscular Placebo (Optional Sub-study Participants Post-challenge)
n=38 participants at risk
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo and also volunteered for the optional substudy.
|
BPZE1 and Boostrix Intramuscular (Optional Sub-study Participants Post-challenge)
n=36 participants at risk
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine) and also volunteered for the optional substudy.
|
Placebo Intranasal and Boostrix Intramuscular (Optional Sub-study Participants Post-challenge)
n=46 participants at risk
Participants received an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator) and also volunteered for the optional substudy.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.81%
1/123 • Number of events 1 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/121 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/122 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/38 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/36 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/46 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/123 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/121 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.82%
1/122 • Number of events 1 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/38 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/36 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/46 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/123 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/121 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.82%
1/122 • Number of events 1 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/38 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/36 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/46 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
Other adverse events
| Measure |
BPZE1 and Intramuscular Placebo (All Participants Post-vaccination)
n=123 participants at risk
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo (including all participants, those who participated in the optional substudy and those who did not participate in the optional substudy).
|
BPZE1 and Boostrix Intramuscular (All Participants Post-vaccination)
n=121 participants at risk
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine) (including all participants, those who participated in the optional substudy and those who did not participate in the optional substudy).
|
Placebo Intranasal and Boostrix Intramuscular (All Participants Post-vaccination)
n=122 participants at risk
Participants received an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator) (including all participants, those who participated in the optional substudy and those who did not participate in the optional substudy).
|
BPZE1 and Intramuscular Placebo (Optional Sub-study Participants Post-challenge)
n=38 participants at risk
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo and also volunteered for the optional substudy.
|
BPZE1 and Boostrix Intramuscular (Optional Sub-study Participants Post-challenge)
n=36 participants at risk
Participants received an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine) and also volunteered for the optional substudy.
|
Placebo Intranasal and Boostrix Intramuscular (Optional Sub-study Participants Post-challenge)
n=46 participants at risk
Participants received an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator) and also volunteered for the optional substudy.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.7%
7/123 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
1.7%
2/121 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
2.5%
3/122 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/38 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
5.6%
2/36 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
4.3%
2/46 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
2/123 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
1.7%
2/121 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
2.5%
3/122 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/38 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
5.6%
2/36 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
2.2%
1/46 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
4/123 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.83%
1/121 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
2.5%
3/122 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
2.6%
1/38 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
2.8%
1/36 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/46 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
|
General disorders
Other
|
14.6%
18/123 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
11.6%
14/121 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
13.1%
16/122 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
2.6%
1/38 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
13.9%
5/36 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
15.2%
7/46 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/123 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/121 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.82%
1/122 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
5.3%
2/38 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/36 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
0.00%
0/46 • SAEs and deaths collected through end of study - up to 6 months. Unsolicited AEs collected up to 28 days post-vaccination (All participants) and 28 days post-challenge (Only optional Substudy participants).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60