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CompletedNCT03942406Updated Jun 27, 2023Results posted

Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults

A Phase 2 interventional study of BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device in Pertussis and Whooping Cough, sponsored by ILiAD Biotechnologies. Completed at 3 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-27.

Sponsored by ILiAD Biotechnologies · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

This study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares a single (prime) BPZE1 dose or BPZE1 2-dose (prime + boost) to a single (prime) Boostrix or Boostrix prime + BPZE1 boost.

Read the detailed description

This study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares a single (prime) BPZE1 dose or BPZE1 2-dose (prime + boost) to a single (prime) Boostrix or Boostrix prime + BPZE1 boost. This is a multi-center, randomized, placebo-controlled, and observer blinded trial in healthy adults with a 6 month safety follow-up after the last vaccination.

02

Conditions studied

  • Pertussis
  • Whooping Cough

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Keywords

  • pertussis
  • Bordetella infection
  • Gram-negative bacterial infection
  • Respiratory tract infection
  • Whooping cough
  • Infection
  • Respiratory tract disease
  • Vaccine
  • Immunological factors
  • Physiological effects of drugs
03

In context

Whooping Cough

238 studies on the registry are indexed under Whooping Cough; 15 are open to participants now.

This study's enrollment of 300 is below the median of 375 across 180 interventional studies indexed under Whooping Cough.

Browse Whooping Cough studies →

Lead sponsor

ILiAD Biotechnologies is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Is a male or nonpregnant female 18 to 50 years of age, inclusive, on Day 1 (primary vaccination).
  2. Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.

  3. Female subjects must be nonpregnant and nonlactating and meet 1 of the following criteria:

    1. Postmenopausal (defined as 12 consecutive months with no menses without an alternative medical cause or documented plasma follicle-stimulating hormone level in the postmenopausal range);

    2. Surgically sterile (ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).

      NOTE: These procedures and laboratory test results must be confirmed by physical examination, or by subject recall of specific date and hospital/facility of procedure, or by medical documentation of said procedure.

    3. Is of childbearing potential (defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal), agrees to be heterosexually inactive from at least 21 days prior to enrollment and through 3 months after the boosting vaccination or agrees to consistently use any of the following methods of contraception from at least 21 days prior to enrollment and through 3 months after the boosting vaccination:

    i. Condoms (male or female) with spermicide ii. Diaphragm with spermicide iii. Cervical cap with spermicide iv. Intrauterine device v. Oral or patch contraceptives vi. Norplant®, Depo-Provera®, or other FDA approved contraceptive method that is designed to protect against pregnancy.

    NOTE: Periodic abstinence (eg, calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception.

  4. Has a stable health status as assessed by the investigator, as established by physical examination, vital sign measurements, and medical history.
  5. Has access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device.
  6. Is able to understand and comply with planned study procedures.
  7. Lives a reasonable distance from the clinical site to be able to travel to and from the clinical site for follow-up visits and agrees to go to the clinical site for evaluation (or provide medical record access if evaluated elsewhere) in the event of an AE.
  8. Agrees to stay in contact with the clinical site for the duration of the study, has no current plans to move from the study area, and provides updated contact information as necessary.

Exclusion criteria

Exclusion Criteria:

  1. History of being vaccinated in the past 5 years against pertussis.
  2. Any significant past reaction to any component of Boostrix (at the discretion of the investigator).
  3. Subject reported diagnosis of pertussis in the past 10 years (must be laboratory confirmed or physician diagnosed from medical records).
  4. Vital signs by FDA toxicity scoring >1 (may be repeated once during the screening period to allow for inclusion and the most recent measurement taken at baseline).
  5. Chronic illness being treated actively and with evidence of recent intervention for worsening or fluctuating symptoms (at the discretion of the investigator).
  6. The subject has a history of active cancer (malignancy) in the last 10 years (exception is subjects with adequately treated non melanomatous skin carcinoma, who may participate in the study).
  7. Current use of any smoking products and unwillingness to refrain from the use of any smoking products from screening through 28 days after the boosting vaccination.
  8. Use of narcotic drugs, evidenced by urine toxicology screen or a history of drug/alcohol abuse within the past 2 years.
  9. Has donated blood or suffered from blood loss of more than 450 mL (1 unit of blood) within 60 days prior to screening or donated plasma within 14 days prior to screening.
  10. Receipt of immunoglobulin, blood-derived products, systemic corticosteroids, or other immunosuppressant drugs within 90 days prior to Day 1.
  11. Asthma, obstructive nasal canal, recurrent or acute sinusitis or other chronic respiratory problems inclusive of the diagnosis of any significant pulmonary disease.
  12. History of nasal surgery or Bell's palsy.
  13. Use of repeated nasal sprays, Neti pot, routine nasal washing within the past 1 month (more than 2 times per week). Subjects must agree to refrain from use of any of these modalities through Day 113.

  14. A temporary exclusion to vaccinate if acute respiratory tract infection or rhinorrhea or temperature >100.4°F (no symptoms for 3 days prior to vaccination day). Subjects may be vaccinated if they stay within the vaccination window (screening [30 days] or at the time of the booster [10 days]).

    NOTE: If a subject exceeds the screening window, they must be reconsented and screening must be reinitiated.

  15. Use of corticosteroids in the respiratory tract (eg, nasal steroids, inhaled steroids) within 30 days prior to Day 1.
  16. Receipt of a licensed vaccine within the last 30 days prior to Day 1 or planned vaccination during the active study conduct through Day 113. In the case of seasonal influenza, vaccination should not be withheld and is not contraindicated for subject participation. However, vaccination should be planned outside of a 30 day pre- and 30 day post vaccination window whenever possible.
  17. Known hypersensitivity to any component of the study vaccines.
  18. Participation in any other clinical trial for the testing of an unlicensed product during the previous 6 months or planned during the study conduct.
  19. Inability to adhere to the protocol, including plans to move from the area.
  20. Personal history or family (first degree) history of congenital or hereditary immunodeficiency.
  21. Past or present infection with human immunodeficiency virus, hepatitis B, or hepatitis C by screening test.
  22. Any autoimmune or immunodeficiency disease/condition (inherited or iatrogenic).
  23. Any neurological disease or history of significant neurological disorder (eg, meningitis, seizures, multiple sclerosis, vasculitis, migraines, Guillain-Barré syndrome [genetic/congenital or acquired]).
  24. Any medical condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might affect the safety of the individual, (eg, major depression or history of suicidal attempt).
  25. Toxicity grading >1 for screening laboratory test results for kidney, hepatic, and hematologic values (may be repeated once during the screening period to allow for inclusion and the most recent measurement taken at baseline). See Table 13 2 for specifically designated parameters.
  26. Body mass index \<17 kg/m2 or >40 kg/m2.
  27. Frequent contact with children less than 1 year of age (parent, childcare worker, nurse, etc.) or residence in the same household as persons with known immunodeficiency including persons on immunosuppressant therapy.
  28. Study team member or first-degree relative of study team member.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    BPZE1 Intranasal Prime, BPZE1 Boost

    Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of intramuscular (I.M.) placebo. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device.

    Combination Product: BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device

  • Experimental
    BPZE1 Intranasal Prime, Placebo Boost

    Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of intramuscular (I.M.) placebo. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device.

    Combination Product: BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device

  • Experimental
    Boostrix IM Prime, BPZE1 Boost

    Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of intramuscular (I.M.) Boostrix (aP vaccine comparator). Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device.

    Combination Product: BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device

  • Active comparator
    Boostrix IM Prime, Placebo Boost

    Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of intramuscular (I.M.) Boostrix (aP vaccine comparator). Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device.

    Combination Product: BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device

Interventions

  • Combination productBPZE1 pertussis vaccine and VaxINator(TM) Atomization Device

    Live attenuated pertussis vaccine administered via the VaxINator(TM) atomization device

06

What researchers measure

Primary outcomes

  1. Number of Participants With Nasal Mucosal Seroconversion (Immunoglobulin A [IgA])

    Number of participants who achieve mucosal seroconversion (IgA) against at least 1 anti-pertussis antibody for whole cell extract (WCE), pertussis toxin (PT), filamentous hemagglutinin (FHA), or pertactin (PRN) on Day 29 or Day 113. Mucosal seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value was below the detection limits of the assay).

    Time frame: Days 29 and 113

  2. Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)

    Number of participants with Solicited AEs (nasal/respiratory reactogenicity events) by Grade - Any Day Grade 1 through 3 and Grade 3. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) AEs.

    Time frame: Through 7 Days Following Day 1 Vaccination

  3. Safety - Number of Participants With Local Solicited AEs

    Number of participants with Solicited AEs (local reactogenicity events) by Grade - Any Day Grade 1 through 4 and Grade 3 and 4. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) AEs.

    Time frame: Through 7 Days Following Day 1 Vaccination

  4. Safety - Number of Participants With Systemic Solicited AEs

    Number of participants with Solicited AEs (systemic reactogenicity events) by Grade - Any Day Grade 1 through 3 and Grade 3. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) AEs.

    Time frame: Through 7 Days Following Day 1 Vaccination

  5. Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)

    Number of participants in the safety lead-in cohort with Grade 2 through 4 laboratory abnormalities: Serum Chemistry - Bilirubin, Creatinine, ALT, AST; WBC, Hemoglobin, Prothrombin time, Partial Thromboplastin Time. Grading of laboratory results is defined per protocol as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threatening) laboratory abnormalities (DHHS 2007).

    Time frame: Days 8 and 92

Secondary outcomes

  1. Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints

    Number of participants who achieve seroconversion (serum IgG) against 1 or more pertussis antigens (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\], or whole cell extract \[WCE\]) on Days 29, 85, 113, 169, and/or 254. Systemic seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value fell below the detection limits of the assay).

    Time frame: 9 months

  2. Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints

    Number of participants who achieve seroconversion (serum IgA) against 1 or more pertussis antigens (PT, FHA, PRN) on Days 29, 85, 113, 169, and/or 254. Systemic seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value fell below the detection limits of the assay).

    Time frame: 9 Months

  3. Systemic Immunogenicity - Summary of Geometric Mean Fold Rises (GMFRs) of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point

    Systemic Immunogenicity: Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 29 and Day 85 over baseline (Day 1)

    Time frame: Days 29 and 85

  4. Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point

    Systemic Immunogenicity: Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Days 113, 169, and 254 over baseline (Day 1)

    Time frame: Days 113, 169 and 254

  5. Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints

    Number of participants who achieve seroconversion against any pertussis specific antigen (PT, PRN, FHA, or WCE) in nasal secretions (S-IgA). Mucosal seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value was below the detection limits of the assay).

    Time frame: 9 months

  6. Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point

    Mucosal Immunogenicity: Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 29 and Day 78 over baseline (Day 1)

    Time frame: Days 29 and 78

  7. Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point

    Mucosal Immunogenicity: Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 113, Day 169, and Day 254 over baseline (Day 1)

    Time frame: Days 113, 169, 254

  8. Colonization - Summary of Colonization for B. Pertussis Bacterial Culture From Nasal Sample by Timepoint

    Number of participants with positive B. pertussis by bacterial culture of nasal sample on any of Days 92, 96, and 113 (colonization)

    Time frame: Days 92, 96, 113

  9. Safety - Number of Participants With Unsolicited AEs

    Number of participants with Unsolicited AEs collected Day 1 to Day 29 by Medical Dictionary for Regulatory Activities (MedDRA) classification. Threshold is greater than or equal to 5% of participants.

    Time frame: Days 1 through 29

  10. Safety - Number of Participants With Unsolicited AEs

    Number of participants with Unsolicited AEs Day 85 through Day 113 by MedDRA classification. Threshold is greater than or equal to 5% of participants.

    Time frame: Days 85 through 113

  11. Safety - Number of Participants With Serious AEs

    Number of participants with Serious AEs collected on Day 1 through Day 84 by MedDRA classification.

    Time frame: Days 1 to 84

  12. Safety - Number of Participants With Serious AEs

    Number of participants with Serious AEs collected on Day 85 through Day 113 by MedDRA classification.

    Time frame: Days 85 to 113

  13. Safety - Number of Participants With Serious AEs

    Number of participants with Serious AEs collected on Day 114 through Day 254 by MedDRA classification.

    Time frame: Days 114 to 254 (end of study)

07

Results

Posted Jun 27, 2023

Participant flow

Period 1 (Day 1): Prime; Period 2 (Day 85): Boost 300 participants: * 20 received BPZE1 10\^7 CFU as a Safety Lead-in cohort (Prime/Boost: BPZE1/BPZE1 \[n=8\]; BPZE1/Placebo \[n=8\]; Boostrix/BPZE1 \[n=4\]). Safety Lead-in cohort used for one secondary endpoint (abnormal laboratory) and Safety. * 280 in 10\^9 ITT Analysis Set (Prime/Boost: BPZE 10\^9/BPZE1 10\^9 \[n=92\]; BPZE1 10\^9/Placebo \[n=92\]; Boostrix/BPZE1 10\^9 \[n=46\], and Boostrix/Placebo \[n=50\]).

Participant flow — Overall Study
MilestoneBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo BoostBPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) BoostBPZE1 (10^7) Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 (10^7) Boost
Started92924650884
Completed81854140674
Not completed117510210
Withdrew: Lost to follow-up4537100
Withdrew: Withdrawal by subject3113000
Withdrew: Other: early termination, telemedicine visits4110110

Outcome measures

PrimaryNumber of Participants With Nasal Mucosal Seroconversion (Immunoglobulin A [IgA])

Number of participants who achieve mucosal seroconversion (IgA) against at least 1 anti-pertussis antibody for whole cell extract (WCE), pertussis toxin (PT), filamentous hemagglutinin (FHA), or pertactin (PRN) on Day 29 or Day 113. Mucosal seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value was below the detection limits of the assay).

Time frame:
Days 29 and 113
Reported as:
Count of participants · Participants
Number of Participants With Nasal Mucosal Seroconversion (Immunoglobulin A [IgA])
ParticipantsBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo Boost
Number of Participants With Nasal Mucosal Seroconversion (Immunoglobulin A [IgA])79893842
PrimarySafety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)

Number of participants with Solicited AEs (nasal/respiratory reactogenicity events) by Grade - Any Day Grade 1 through 3 and Grade 3. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) AEs.

Time frame:
Through 7 Days Following Day 1 Vaccination
Reported as:
Number · participants
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
participantsBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo Boost
Runny Nose - Any Day Grade 1 through 325411716
Runny Nose - Any Day Grade 30000
Stuffy Nose/Congestion - Any Day Grade 1 through 327441915
Stuffy Nose/Congestion - Any Day Grade 30000
Nasal Pain/Irritation - Any Day Grade 1 through 3101377
Nasal Pain/Irritation - Any Day Grade 30000
Epistaxis - Any Day Grade 1 through 31521
Epistaxis - Any Day Grade 30000
Sneezing - Any Day Grade 1 through 325351513
Sneezing - Any Day Grade 30000
Sinus Pressure/Pain - Any Day Grade 1 through 31219510
Sinus Pressure/Pain - Any Day Grade 30000
Sore/Irritated Throat - Any Day Grade 1 through 32229810
Sore/Irritated Throat - Any Day Grade 30000
Cough - Any Day Grade 1 through 31118109
Cough - Any Day Grade 30000
Shortness of Breath/Wheezing - Any Day Grade 1 through 31723
Shortness of Breath/Wheezing - Any Day Grade 30000
PrimarySafety - Number of Participants With Local Solicited AEs

Number of participants with Solicited AEs (local reactogenicity events) by Grade - Any Day Grade 1 through 4 and Grade 3 and 4. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) AEs.

Time frame:
Through 7 Days Following Day 1 Vaccination
Reported as:
Number · participants
Safety - Number of Participants With Local Solicited AEs
participantsBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo Boost
Pain - Any Day Grade 1 Through 4872227
Pain - Any Day Grade 3 and 40000
Tenderness - Any Day Grade 1 Through 415132830
Tenderness - Any Day Grade 3 and 40000
Erythema/Redness - Any Day Grade 1 Through 40212
Erythema/Redness - Any Day Grade 3 and 40000
Induration/Swelling - Any Day Grade 1 Through 40042
Induration/Swelling - Any Day Grade 3 and 40000
PrimarySafety - Number of Participants With Systemic Solicited AEs

Number of participants with Solicited AEs (systemic reactogenicity events) by Grade - Any Day Grade 1 through 3 and Grade 3. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) AEs.

Time frame:
Through 7 Days Following Day 1 Vaccination
Reported as:
Number · participants
Safety - Number of Participants With Systemic Solicited AEs
participantsBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo Boost
Fever - Any Day Grade 1 through 30100
Fever - Any Day Grade 30100
Fatigue (Tiredness) - Any Day Grade 1 through 32735912
Fatigue (Tiredness) - Any Day Grade 30100
Malaise (General Unwell Feeling) - Any Day Grade 1 through 3132568
Malaise (General Unwell Feeling) - Any Day Grade 30100
Myalgia (Body Aches/Muscular Pain) - Any Day Grade 1 through 381948
Myalgia (Body Aches/Muscular Pain) - Any Day Grade 30100
Arthralgia (Joint Pain) - Any Day Grade 1 through 35714
Arthralgia (Joint Pain) - Any Day Grade 30000
Headache - Any Day Grade 1 through 331371322
Headache - Any Day Grade 30100
Rash/Hypersensitivity - Any Day Grade 1 through 30401
Rash/Hypersensitivity - Any Day Grade 30100
PrimarySafety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)

Number of participants in the safety lead-in cohort with Grade 2 through 4 laboratory abnormalities: Serum Chemistry - Bilirubin, Creatinine, ALT, AST; WBC, Hemoglobin, Prothrombin time, Partial Thromboplastin Time. Grading of laboratory results is defined per protocol as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threatening) laboratory abnormalities (DHHS 2007).

Time frame:
Days 8 and 92
Reported as:
Count of participants · Participants
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
ParticipantsBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 Boost
Bilirubin Increase Day 8100
Bilirubin Increase Day 92000
Creatinine Day 8000
Creatinine Day 92000
ALT Day 8000
ALT Day 92000
AST Day 8000
AST Day 92000
WBC decrease Day 8000
WBC decrease Day 92000
WBC Increase Day 8000
WBC Increase Day 92000
Hemoglobin Day 8001
Hemoglobin Day 92001
Platelets Decrease Day 8000
Platelets Decrease Day 92000
Prothrombin Time Increase by Factor Day 8200
Prothrombin Time Increase by Factor Day 92000
Partial Thromboplastin Time Increase by Factor Day 8000
Partial Thromboplastin Time Increase by Factor Day 92000
SecondarySystemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints

Number of participants who achieve seroconversion (serum IgG) against 1 or more pertussis antigens (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\], or whole cell extract \[WCE\]) on Days 29, 85, 113, 169, and/or 254. Systemic seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value fell below the detection limits of the assay).

Time frame:
9 months
Reported as:
Count of participants · Participants
Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints
ParticipantsBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo Boost
At least 1 of WCE, PT, FHA, PRN: Any of Days 29, 85, or 11363714145
At least 1 of WCE, PT, FHA, PRN: Either Day 169 or Day 25454593332
WCE: Either Day 29 or Day 11345412832
PT, FHA, PRN: Either Day 29 or Day 11319162828
At least 2 of WCE, PT, FHA, OR PRN: Any of Days 29, 85, or 11346503741
At least 2 of WCE, PT, FHA, OR PRN: Either Day 169 or Day Day 25440413228
Boosting Achieved on Day 113 (over Day 85) Against WCE8442
SecondarySystemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints

Number of participants who achieve seroconversion (serum IgA) against 1 or more pertussis antigens (PT, FHA, PRN) on Days 29, 85, 113, 169, and/or 254. Systemic seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value fell below the detection limits of the assay).

Time frame:
9 Months
Reported as:
Count of participants · Participants
Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints
ParticipantsBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo Boost
Against at least 1 of PT, FHA, or PRN: Any of Days 29, 85, or 11364714041
Against at least 1 of PT, FHA, or PRN: Either day 169 or Day 25455583229
Against PT, FHA, and PRN: Either Day 29 or Day 1132329189
Against at least 2 of PT, FHA, or PRN: Each Day 29, 85, or 11325281413
Against at least 2 of PT, FHA, or PRN: Any of Days 29, 85, or 11350492830
Against at least 2 of PT, FHA, or PRN: Either Day 169 or Day 25441302414
Boosting Achieved on Day 113 (over Day 85) against PT3240
Boosting Achieved on Day 113 (over Day 85) against FHA6431
Boosting Achieved on Day 113 (over Day 85) against PRN13480
SecondarySystemic Immunogenicity - Summary of Geometric Mean Fold Rises (GMFRs) of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point

Systemic Immunogenicity: Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 29 and Day 85 over baseline (Day 1)

Time frame:
Days 29 and 85
Reported as:
Geometric mean · Ratio
Systemic Immunogenicity - Summary of Geometric Mean Fold Rises (GMFRs) of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point
RatioBPZE1 Intranasal PrimeBoostrix IM Prime
GMFR WCE Day 291.80 (1.63 to 2.00)3.06 (2.57 to 3.64)
GMFR WCE Day 851.76 (1.59 to 1.94)2.30 (1.94 to 2.72)
SecondarySystemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point

Systemic Immunogenicity: Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Days 113, 169, and 254 over baseline (Day 1)

Time frame:
Days 113, 169 and 254
Reported as:
Geometric mean · Ratio
Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point
RatioBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo Boost
GMFR WCE Day 1132.10 (1.79 to 2.48)1.64 (1.42 to 1.89)2.73 (2.01 to 3.71)2.04 (1.63 to 2.56)
GMFR WCE Day 1691.85 (1.57 to 2.18)1.54 (1.34 to 1.78)2.32 (1.67 to 3.22)1.62 (1.33 to 1.98)
GMFR WCE Day 2541.66 (1.41 to 1.96)1.43 (1.26 to 1.61)1.99 (1.52 to 2.59)1.37 (1.12 to 1.66)
SecondaryMucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints

Number of participants who achieve seroconversion against any pertussis specific antigen (PT, PRN, FHA, or WCE) in nasal secretions (S-IgA). Mucosal seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value was below the detection limits of the assay).

Time frame:
9 months
Reported as:
Count of participants · Participants
Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints
ParticipantsBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo Boost
Against at least 1 of WCE, PT, FHA, or PRN: Any of Days 29, 78, or 11375843327
Against at least 1 of WCE, PT, FHA, or PRN: Either Day 169 or Day 25466633013
Against WCE: Either Day 29 or Day 11354642111
Against PT, FHA, PRN: Either Day 29 or Day 113231452
Against at least 2 of WCE, PT, FHA, or PRN: Any of Days 29, 78, or 11364702311
Against at least 2 of WCE, PT, FHA, or PRN: Either Day 169 or Day 2544743173
Boosting achieved on Day 113 (over Day 78) against WCE237116
SecondaryMucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point

Mucosal Immunogenicity: Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 29 and Day 78 over baseline (Day 1)

Time frame:
Days 29 and 78
Reported as:
Geometric mean · Ratio
Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point
RatioBPZE1 Intranasal Prime, BPZE1 BoostBoostrix IM Prime, BPZE1 Boost
GMFR WCE Day 292.22 (1.94 to 2.54)1.07 (0.92 to 1.24)
GMFR WCE Day 782.10 (1.84 to 2.39)1.04 (0.89 to 1.22)
SecondaryMucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point

Mucosal Immunogenicity: Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 113, Day 169, and Day 254 over baseline (Day 1)

Time frame:
Days 113, 169, 254
Reported as:
Geometric mean · Ratio
Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point
RatioBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo Boost
GMFR WCE Day 1132.96 (2.35 to 3.75)2.04 (1.71 to 2.43)1.91 (1.53 to 2.37)1.15 (0.94 to 1.39)
GMFR WCE Day 1692.23 (1.80 to 2.77)1.57 (1.33 to 1.86)1.75 (1.39 to 2.19)0.82 (0.67 to 0.99)
GMFR WCE Day 2541.73 (1.39 to 2.15)1.45 (1.22 to 1.72)1.26 (1.02 to 1.55)0.82 (0.68 to 0.99)
SecondaryColonization - Summary of Colonization for B. Pertussis Bacterial Culture From Nasal Sample by Timepoint

Number of participants with positive B. pertussis by bacterial culture of nasal sample on any of Days 92, 96, and 113 (colonization)

Time frame:
Days 92, 96, 113
Reported as:
Count of participants · Participants
Colonization - Summary of Colonization for B. Pertussis Bacterial Culture From Nasal Sample by Timepoint
ParticipantsBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo Boost
Colonization - Summary of Colonization for B. Pertussis Bacterial Culture From Nasal Sample by Timepoint80280
SecondarySafety - Number of Participants With Unsolicited AEs

Number of participants with Unsolicited AEs collected Day 1 to Day 29 by Medical Dictionary for Regulatory Activities (MedDRA) classification. Threshold is greater than or equal to 5% of participants.

Time frame:
Days 1 through 29
Reported as:
Count of participants · Participants
Safety - Number of Participants With Unsolicited AEs
ParticipantsBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo Boost
Headache5701
Nasal congestion5433
Rhinorrhoea5322
Sneezing6221
SecondarySafety - Number of Participants With Unsolicited AEs

Number of participants with Unsolicited AEs Day 85 through Day 113 by MedDRA classification. Threshold is greater than or equal to 5% of participants.

Time frame:
Days 85 through 113
Reported as:
Count of participants · Participants
Safety - Number of Participants With Unsolicited AEs
ParticipantsBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo Boost
Upper respiratory tract infection4504
Nasal congestion1644
SecondarySafety - Number of Participants With Serious AEs

Number of participants with Serious AEs collected on Day 1 through Day 84 by MedDRA classification.

Time frame:
Days 1 to 84
Reported as:
Count of participants · Participants
Safety - Number of Participants With Serious AEs
ParticipantsBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo Boost
Bacterial sepsis0100
Cellulitis0100
Post procedural haemorrhage1000
Hyperglycaemia0100
SecondarySafety - Number of Participants With Serious AEs

Number of participants with Serious AEs collected on Day 85 through Day 113 by MedDRA classification.

Time frame:
Days 85 to 113
Reported as:
Count of participants · Participants
Safety - Number of Participants With Serious AEs
ParticipantsBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo Boost
Diabetic metabolic decompensation0100
Other0000
SecondarySafety - Number of Participants With Serious AEs

Number of participants with Serious AEs collected on Day 114 through Day 254 by MedDRA classification.

Time frame:
Days 114 to 254 (end of study)
Reported as:
Count of participants · Participants
Safety - Number of Participants With Serious AEs
ParticipantsBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo Boost
Obesity0010
Other0000

Adverse events

Collected over Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BPZE1 Intranasal Prime, BPZE1 Boost0/87 (0%)1/87 (1.1%)25/87 (28.7%)
BPZE1 Intranasal Prime, Placebo Boost0/96 (0%)3/96 (3.1%)26/96 (27.1%)
Boostrix IM Prime, BPZE1 Boost0/46 (0%)1/46 (2.2%)14/46 (30.4%)
Boostrix IM Prime, Placebo Boost0/50 (0%)0/50 (0%)12/50 (24%)
BPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) Boost0/8 (0%)0/8 (0%)3/8 (37.5%)
BPZE1 (10^7) Intranasal Prime, Placebo Boost0/8 (0%)0/8 (0%)2/8 (25%)
Boostrix IM Prime, BPZE1 (10^7) Boost0/4 (0%)0/4 (0%)1/4 (25%)
Most frequent serious events
Most frequent serious events
EventBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo BoostBPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) BoostBPZE1 (10^7) Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 (10^7) Boost
ObesityMetabolism and nutrition disorders0/870/961/460/500/80/80/4
Post procedural haemorrhageInjury, poisoning and procedural complications1/870/960/460/500/80/80/4
Bacterial sepsisInfections and infestations0/871/960/460/500/80/80/4
CellulitisInfections and infestations0/871/960/460/500/80/80/4
HyperglycemiaMetabolism and nutrition disorders0/871/960/460/500/80/80/4
Diabetic metabolic decompensationMetabolism and nutrition disorders0/871/960/460/500/80/80/4
Most frequent other events
Showing 10 of 19
Most frequent other events
EventBPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo BoostBPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) BoostBPZE1 (10^7) Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 (10^7) Boost
HyperkalemiaMetabolism and nutrition disorders1/870/960/460/501/80/81/4
Nasal congestionRespiratory, thoracic and mediastinal disorders1/876/964/464/501/80/80/4
Burns second degreeInjury, poisoning and procedural complications0/870/960/460/501/80/80/4
Coagulation test abnormalInvestigations0/870/960/460/501/80/80/4
HypernatremiaMetabolism and nutrition disorders1/870/960/461/500/81/80/4
DizzinessNervous system disorders0/872/961/460/500/81/80/4
PresyncopeNervous system disorders0/870/960/460/501/80/80/4
EpistaxisRespiratory, thoracic and mediastinal disorders0/870/960/460/501/80/80/4
Dermatitis ContactSkin and subcutaneous tissue disorders0/871/960/460/501/80/80/4
MalaiseGeneral disorders0/872/960/460/501/80/80/4

Baseline characteristics

Age, Continuous
Age, Continuous(years)BPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo BoostBPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) BoostBPZE1 (10^7) Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 (10^7) BoostTotal
Mean35.6 ± 9.035.2 ± 8.834.6 ± 9.034.2 ± 9.931.6 ± 10.334.6 ± 8.735.5 ± 12.035.0 ± 9.1
Sex: Female, Male
Sex: Female, Male(Participants)BPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo BoostBPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) BoostBPZE1 (10^7) Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 (10^7) BoostTotal
Female56462627343165
Male36462023541135
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo BoostBPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) BoostBPZE1 (10^7) Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 (10^7) BoostTotal
Hispanic or Latino15118701042
Not Hispanic or Latino77813843874258
Unknown or Not Reported00000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo BoostBPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) BoostBPZE1 (10^7) Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 (10^7) BoostTotal
American Indian or Alaska Native00000000
Asian11510008
Native Hawaiian or Other Pacific Islander12000003
Black or African American19229801261
White70653141772223
More than one race02101004
Unknown or Not Reported10000001
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)BPZE1 Intranasal Prime, BPZE1 BoostBPZE1 Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 BoostBoostrix IM Prime, Placebo BoostBPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) BoostBPZE1 (10^7) Intranasal Prime, Placebo BoostBoostrix IM Prime, BPZE1 (10^7) BoostTotal
Mean28.0 ± 5.428.1 ± 5.627.7 ± 5.027.2 ± 5.026.7 ± 7.731.1 ± 7.029.6 ± 7.327.9 ± 5.3
08

Study locations

3 sites
  • Rapid medical Research Inc
    Cleveland, Ohio 44122, United States
  • DM Clinical Research
    Tomball, Texas 77375, United States
  • Advanced Clinical Research
    West Jordan, Utah 84088, United States
09

References and documents

Publications

  • Althouse BM, Scarpino SV. Asymptomatic transmission and the resurgence of Bordetella pertussis. BMC Med. 2015 Jun 24;13:146. doi: 10.1186/s12916-015-0382-8. PubMed 26103968 ↗
  • Feunou PF, Ismaili J, Debrie AS, Huot L, Hot D, Raze D, Lemoine Y, Locht C. Genetic stability of the live attenuated Bordetella pertussis vaccine candidate BPZE1. Vaccine. 2008 Oct 23;26(45):5722-7. doi: 10.1016/j.vaccine.2008.08.018. Epub 2008 Aug 30. PubMed 18762220 ↗
  • Feunou PF, Mielcarek N, Locht C. Reciprocal interference of maternal and infant immunization in protection against pertussis. Vaccine. 2016 Feb 17;34(8):1062-9. doi: 10.1016/j.vaccine.2016.01.011. Epub 2016 Jan 15. PubMed 26776471 ↗
  • Locht C, Papin JF, Lecher S, Debrie AS, Thalen M, Solovay K, Rubin K, Mielcarek N. Live Attenuated Pertussis Vaccine BPZE1 Protects Baboons Against Bordetella pertussis Disease and Infection. J Infect Dis. 2017 Jul 1;216(1):117-124. doi: 10.1093/infdis/jix254. PubMed 28535276 ↗
  • Mielcarek N, Debrie AS, Raze D, Bertout J, Rouanet C, Younes AB, Creusy C, Engle J, Goldman WE, Locht C. Live attenuated B. pertussis as a single-dose nasal vaccine against whooping cough. PLoS Pathog. 2006 Jul;2(7):e65. doi: 10.1371/journal.ppat.0020065. PubMed 16839199 ↗
  • Mielcarek N, Debrie AS, Mahieux S, Locht C. Dose response of attenuated Bordetella pertussis BPZE1-induced protection in mice. Clin Vaccine Immunol. 2010 Mar;17(3):317-24. doi: 10.1128/CVI.00322-09. Epub 2010 Jan 27. PubMed 20107007 ↗
  • Skerry CM, Cassidy JP, English K, Feunou-Feunou P, Locht C, Mahon BP. A live attenuated Bordetella pertussis candidate vaccine does not cause disseminating infection in gamma interferon receptor knockout mice. Clin Vaccine Immunol. 2009 Sep;16(9):1344-51. doi: 10.1128/CVI.00082-09. Epub 2009 Jul 22. PubMed 19625486 ↗
  • Warfel JM, Zimmerman LI, Merkel TJ. Acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model. Proc Natl Acad Sci U S A. 2014 Jan 14;111(2):787-92. doi: 10.1073/pnas.1314688110. Epub 2013 Nov 25. PubMed 24277828 ↗

Study documents

  • Study protocol · Nov 20, 2019
  • Statistical analysis plan · Mar 11, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03942406
Lead sponsor
ILiAD Biotechnologies
Collaborators
PPD DEVELOPMENT, LP
Responsible party
Sponsor
First posted
May 8, 2019
Start date
Jun 15, 2019
Primary completion
Feb 14, 2020
Completion
Jun 24, 2020
Results posted
Jun 27, 2023
Last update
Jun 27, 2023

Study contacts

Mary B Manning, MD
principal investigator · Rapid Medical Research Inc
Barbara Rizzardi, MD
principal investigator · Advanced Clinical Research Services, LLC
Vicki Miller, MD
principal investigator · DM Clinical Research

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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