Trial Outcomes & Findings for Pertussis Challenge Study in Adults Vaccinated With BPZE1 (NCT NCT05461131)
NCT ID: NCT05461131
Last Updated: 2025-03-12
Results Overview
Participants by treatment group (BPZE1 and placebo) colonized on any day (Challenge Day 9, 11 or 14) following virulent challenge as determined by culture.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Challenge Day 9, 11 or 14
Results posted on
2025-03-12
Participant Flow
Participant milestones
| Measure |
BPZE1
Participants will receive an intranasal dose of BPZE1 via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
BPZE1: Live attenuated B. pertussis vaccine
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
Placebo
Participants will receive an intranasal dose of placebo via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
Placebo: Placebo
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
|
Overall Study
Challenged With Virulent B. Pertussis
|
24
|
22
|
|
Overall Study
COMPLETED
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
BPZE1
Participants will receive an intranasal dose of BPZE1 via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
BPZE1: Live attenuated B. pertussis vaccine
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
Placebo
Participants will receive an intranasal dose of placebo via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
Placebo: Placebo
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Pertussis Challenge Study in Adults Vaccinated With BPZE1
Baseline characteristics by cohort
| Measure |
BPZE1
n=26 Participants
Participants will receive an intranasal dose of BPZE1 via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
BPZE1: Live attenuated B. pertussis vaccine
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
Placebo
n=27 Participants
Participants will receive an intranasal dose of placebo via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
Placebo: Placebo
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
29.3 years
STANDARD_DEVIATION 7.77 • n=99 Participants
|
31.4 years
STANDARD_DEVIATION 9.16 • n=107 Participants
|
30.4 years
STANDARD_DEVIATION 8.49 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
26 participants
n=99 Participants
|
27 participants
n=107 Participants
|
53 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Challenge Day 9, 11 or 14Population: Subjects who received an adequate inoculum defined prospectively as challenge dose \>=0.5x10\^5 CFU were evaluated.
Participants by treatment group (BPZE1 and placebo) colonized on any day (Challenge Day 9, 11 or 14) following virulent challenge as determined by culture.
Outcome measures
| Measure |
BPZE1
n=20 Participants
Participants will receive an intranasal dose of BPZE1 via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
BPZE1: Live attenuated B. pertussis vaccine
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
Placebo
n=16 Participants
Participants will receive an intranasal dose of placebo via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
Placebo: Placebo
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
|---|---|---|
|
Number of Participants Colonized Following Virulent Challenge
|
8 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Available baseline and Day 28 samples
The geometric mean fold rise (GMFR) of mucosal anti-pertussis S-IgA antibody (whole cell extract \[WCE\], FHA, PRN, PT and fimbriae types 2 and 3 \[FIM2/3\]) from baseline to Day 28 (BPZE1 and placebo). Secretory IgA to be normalized (\[specific S-IgA\]/\[total S-IgA\])
Outcome measures
| Measure |
BPZE1
n=26 Participants
Participants will receive an intranasal dose of BPZE1 via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
BPZE1: Live attenuated B. pertussis vaccine
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
Placebo
n=25 Participants
Participants will receive an intranasal dose of placebo via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
Placebo: Placebo
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
|---|---|---|
|
GMFR of Mucosal Anti-pertussis S-IgA Antibody
WCE
|
3.2 Geometric Mean Fold Rise
Interval 2.1 to 4.7
|
1.0 Geometric Mean Fold Rise
Interval 0.8 to 1.3
|
|
GMFR of Mucosal Anti-pertussis S-IgA Antibody
FHA
|
5.0 Geometric Mean Fold Rise
Interval 3.0 to 8.2
|
1.1 Geometric Mean Fold Rise
Interval 0.8 to 1.5
|
|
GMFR of Mucosal Anti-pertussis S-IgA Antibody
PRN
|
5.3 Geometric Mean Fold Rise
Interval 2.9 to 9.8
|
1.0 Geometric Mean Fold Rise
Interval 0.7 to 1.3
|
|
GMFR of Mucosal Anti-pertussis S-IgA Antibody
PT
|
1.7 Geometric Mean Fold Rise
Interval 1.2 to 2.5
|
1.2 Geometric Mean Fold Rise
Interval 0.9 to 1.6
|
|
GMFR of Mucosal Anti-pertussis S-IgA Antibody
FIM 2/3
|
9.1 Geometric Mean Fold Rise
Interval 4.9 to 16.9
|
1.1 Geometric Mean Fold Rise
Interval 0.9 to 1.4
|
SECONDARY outcome
Timeframe: Day 28Population: Available baseline and Day 28 samples
The GMFR of serum IgA antibody (WCE, FHA, PRN, PT and FIM2/3) from baseline to Day 28 (BPZE1 and placebo)
Outcome measures
| Measure |
BPZE1
n=26 Participants
Participants will receive an intranasal dose of BPZE1 via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
BPZE1: Live attenuated B. pertussis vaccine
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
Placebo
n=25 Participants
Participants will receive an intranasal dose of placebo via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
Placebo: Placebo
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
|---|---|---|
|
GMFR of Serum IgA Antibody
WCE
|
2.6 Geometric Mean Fold Rise
Interval 1.9 to 3.4
|
1.2 Geometric Mean Fold Rise
Interval 1.0 to 1.4
|
|
GMFR of Serum IgA Antibody
FHA
|
3.0 Geometric Mean Fold Rise
Interval 2.2 to 4.0
|
1.1 Geometric Mean Fold Rise
Interval 1.0 to 1.3
|
|
GMFR of Serum IgA Antibody
PRN
|
3.7 Geometric Mean Fold Rise
Interval 2.2 to 6.2
|
1.0 Geometric Mean Fold Rise
Interval 0.9 to 1.1
|
|
GMFR of Serum IgA Antibody
PT
|
1.5 Geometric Mean Fold Rise
Interval 1.1 to 2.0
|
1.1 Geometric Mean Fold Rise
Interval 1.0 to 1.3
|
|
GMFR of Serum IgA Antibody
FIM 2/3
|
5.0 Geometric Mean Fold Rise
Interval 3.1 to 8.2
|
1.0 Geometric Mean Fold Rise
Interval 1.0 to 1.1
|
SECONDARY outcome
Timeframe: Day 28Population: Available baseline and Day 28 samples
The GMFR of serum IgG antibody (WCE, FHA, PRN, PT and FIM2/3) from baseline to Day 28 (BPZE1 and placebo)
Outcome measures
| Measure |
BPZE1
n=26 Participants
Participants will receive an intranasal dose of BPZE1 via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
BPZE1: Live attenuated B. pertussis vaccine
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
Placebo
n=25 Participants
Participants will receive an intranasal dose of placebo via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
Placebo: Placebo
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
|---|---|---|
|
GMFR of Serum IgG Antibody
FHA
|
1.7 Geometric Mean Fold Rise
Interval 1.2 to 2.2
|
1.0 Geometric Mean Fold Rise
Interval 0.8 to 1.2
|
|
GMFR of Serum IgG Antibody
WCE
|
1.5 Geometric Mean Fold Rise
Interval 1.3 to 1.7
|
1.1 Geometric Mean Fold Rise
Interval 1.0 to 1.1
|
|
GMFR of Serum IgG Antibody
PRN
|
3.1 Geometric Mean Fold Rise
Interval 1.9 to 5.0
|
1.1 Geometric Mean Fold Rise
Interval 0.8 to 1.5
|
|
GMFR of Serum IgG Antibody
PT
|
2.1 Geometric Mean Fold Rise
Interval 1.4 to 3.0
|
1.0 Geometric Mean Fold Rise
Interval 0.7 to 1.3
|
|
GMFR of Serum IgG Antibody
FIM 2/3
|
2.9 Geometric Mean Fold Rise
Interval 1.9 to 4.5
|
0.9 Geometric Mean Fold Rise
Interval 0.7 to 1.2
|
SECONDARY outcome
Timeframe: Day 7Population: Safety analysis set
Occurrence and intensity of solicited AEs for nasal/respiratory and systemic reactogenicity through 7 days following vaccination by treatment group (BPZE1 and placebo)
Outcome measures
| Measure |
BPZE1
n=26 Participants
Participants will receive an intranasal dose of BPZE1 via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
BPZE1: Live attenuated B. pertussis vaccine
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
Placebo
n=27 Participants
Participants will receive an intranasal dose of placebo via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
Placebo: Placebo
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
|---|---|---|
|
Safety: Number of Participants With Solicited AEs for Reactogenicity
Nasal/Respiratory
|
17 Participants
|
20 Participants
|
|
Safety: Number of Participants With Solicited AEs for Reactogenicity
Systemic
|
18 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Safety analysis set
Occurrence and intensity of TEAEs through 28 days following study vaccination and following challenge by treatment group (BPZE1 and placebo)
Outcome measures
| Measure |
BPZE1
n=26 Participants
Participants will receive an intranasal dose of BPZE1 via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
BPZE1: Live attenuated B. pertussis vaccine
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
Placebo
n=27 Participants
Participants will receive an intranasal dose of placebo via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
Placebo: Placebo
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
|---|---|---|
|
Safety: Number of Participants With Treatment Emergent Adverse Events
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 60-120 post vaccination and Day 90 post challengePopulation: Safety analysis set
Occurrence and intensity of TEAEs related to vaccination from time of vaccination to challenge or related to challenge for 3 months after challenge by treatment group (BPZE1 and placebo)
Outcome measures
| Measure |
BPZE1
n=26 Participants
Participants will receive an intranasal dose of BPZE1 via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
BPZE1: Live attenuated B. pertussis vaccine
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
Placebo
n=27 Participants
Participants will receive an intranasal dose of placebo via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
Placebo: Placebo
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
|---|---|---|
|
Safety: Number of Participants With TEAEs Related to Vaccination or Related to Challenge
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 180Population: Safety analysis set
Occurrence, intensity, and relationship to study vaccine of AESIs and SAEs from vaccination through end of study (EOS) by treatment group (BPZE1 and placebo)
Outcome measures
| Measure |
BPZE1
n=26 Participants
Participants will receive an intranasal dose of BPZE1 via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
BPZE1: Live attenuated B. pertussis vaccine
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
Placebo
n=27 Participants
Participants will receive an intranasal dose of placebo via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
Placebo: Placebo
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
|---|---|---|
|
Safety: Number of Participants With AESI and SAE
AESI (COVID-19)
|
0 Participants
|
1 Participants
|
|
Safety: Number of Participants With AESI and SAE
SAE
|
0 Participants
|
0 Participants
|
Adverse Events
BPZE1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BPZE1
n=26 participants at risk
Participants will receive an intranasal dose of BPZE1 via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
BPZE1: Live attenuated B. pertussis vaccine
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
Placebo
n=27 participants at risk
Participants will receive an intranasal dose of placebo via the mucosal atomization device followed by a dose of the challenge strain (B. pertussis strain 1917) approximately 60-120 days later. Participants will receive azithromycin for 3 days beginning 14 days after administration of the challenge strain.
Placebo: Placebo
Azithromycin: Antibiotic
Bordetella Pertussis strain 1917 Challenge: Challenge Strain
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.5%
3/26 • SAEs and deaths collected through end of study - up to 7 months. Unsolicited AEs collected up to 28 days post-vaccination and 28 days post-challenge.
|
0.00%
0/27 • SAEs and deaths collected through end of study - up to 7 months. Unsolicited AEs collected up to 28 days post-vaccination and 28 days post-challenge.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
3.8%
1/26 • SAEs and deaths collected through end of study - up to 7 months. Unsolicited AEs collected up to 28 days post-vaccination and 28 days post-challenge.
|
7.4%
2/27 • SAEs and deaths collected through end of study - up to 7 months. Unsolicited AEs collected up to 28 days post-vaccination and 28 days post-challenge.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/26 • SAEs and deaths collected through end of study - up to 7 months. Unsolicited AEs collected up to 28 days post-vaccination and 28 days post-challenge.
|
7.4%
2/27 • SAEs and deaths collected through end of study - up to 7 months. Unsolicited AEs collected up to 28 days post-vaccination and 28 days post-challenge.
|
|
General disorders
Other
|
11.5%
3/26 • SAEs and deaths collected through end of study - up to 7 months. Unsolicited AEs collected up to 28 days post-vaccination and 28 days post-challenge.
|
18.5%
5/27 • SAEs and deaths collected through end of study - up to 7 months. Unsolicited AEs collected up to 28 days post-vaccination and 28 days post-challenge.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place