Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years
Phase I, Randomized, Controlled, Observer-Blind, Dose-Ranging Study of Acellular Pertussis and Tetanus-Diptheria-Acellular Pertussis Booster Vaccine in Adults Ages 18 to 40 Years.
2 other identifiers
interventional
420
1 country
1
Brief Summary
This study will evaluate the safety and efficacy of 9 different vaccines containing aP (acellular pertussis) and TdaP (acellular pertussis, tetanus and diphtheria) in healthy subjects 18 to 40 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2012
CompletedFirst Posted
Study publicly available on registry
February 9, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
September 18, 2014
CompletedApril 4, 2016
March 1, 2016
4 months
February 6, 2012
April 30, 2014
March 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed and compared to that of licensed comparator in terms of the number of subjects reporting solicited local and systemic adverse events and other adverse events after vaccination.
Day 1 through 7 after vaccination
The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed in terms of the number of subjects reporting any unsolicited adverse events (AEs) between day 1 to day 30 , serious adverse events (SAEs) and AEs leading to premature withdrawal between day 1 to day 365, after vaccination.
From day 1 to day 365
Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination
The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) on aP booster groups, against pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), following vaccination with different antigenic formulations of aP versus the response to the commercially available comparator are reported.
Day 1 (baseline) and Day 30 post vaccination
GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination
The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP Booster Groups against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.
Day 1 (baseline) and Day 30 post vaccination
GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination
The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP booster groups, against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.
Day 1 (baseline) and Day 30 post vaccination
Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens
The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for different antigenic formulations of aP booster vaccines and for licensed comparator are reported.
Day 30 post vaccination/baseline (Day 1)
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens
The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.
Day 30 post vaccination/baseline (Day 1)
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens
The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.
Day 30 post vaccination/baseline (Day 1)
Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination
The percentages of subjects demonstrating diphtheria and tetanus antitoxin units \>= 0.1/mL following vaccination with different antigenic formulations of TdaP booster vaccine, is compared to the response to commercially available comparator.
Day 1 (baseline) and Day 30 post vaccination
Secondary Outcomes (3)
Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination.
Day 30 post vaccination
GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination
Day 1 (baseline) and Day 30 post vaccination
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens
Day 30 post vaccination/Day 1
Study Arms (10)
Group 1: aP booster
EXPERIMENTALSubjects received acellular pertussis (aP) vaccine with different antigen dose formulations: low dose of PT, FHA, PRN, followed by one fixed dose of diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) administered one month apart.
Group 2: aP booster
EXPERIMENTALSubjects received acellular pertussis (aP) vaccine with different antigen dose formulations: medium dose of PT, FHA, PRN, followed by one fixed dose of diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) administered one month apart.
Group 3: aP booster
EXPERIMENTALSubjects received acellular pertussis (aP) vaccine with different antigen dose formulations: high dose of PT, FHA, PRN, followed by one fixed dose of diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) administered one month apart.
Group 4: TdaP booster
EXPERIMENTALSubjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: low dose of PT, FHA, PRN, low dose of D (diphteria) toxoid, fixed dose of T (tetanus) toxoid, followed by one administration of saline solution one month apart.
Group 5: TdaP booster
EXPERIMENTALSubjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: medium dose of PT, FHA, PRN, low dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart.
Group 6: TdaP booster
EXPERIMENTALSubjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: high dose of PT, FHA, PRN, low dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart.
Group 7: TdaP booster
EXPERIMENTALSubjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: low dose of PT, FHA, PRN, double dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart.
Group 8: TdaP booster
EXPERIMENTALSubjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: medium dose of PT, FHA, PRN, double dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart.
Group 9: TDaP booster
EXPERIMENTALSubjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: high dose of PT, FHA, PRN, double dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart.
Group 10: Licensed TdaP booster
ACTIVE COMPARATORSubject received one dose of a licensed TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) followed by one administration of saline solution one month apart.
Interventions
Acellular pertussis (aP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.
Tetanus, reduced diphtheria, and acellular pertussis (TdaP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.
Licenced TdaP booster vaccine was administered intramuscularly in the upper deltoid region of the subject's non-dominant arm.
To ensure all subjects receive a tetanus and diphtheria booster vaccination, an injection was administered on Study Day 30, one month after the administration of the investigational vaccine.
Subjects received one injection of saline solution at one month after vaccination.
Eligibility Criteria
You may qualify if:
- Healthy male and female individuals between 18 and 40 years of age (inclusive) who had provided informed consent.
- Individuals who were able to be contacted for the duration of the study.
You may not qualify if:
- Individuals who had received vaccines containing T, D, or pertussis (aP or whole cell), been diagnosed with pertussis disease, or who have had a household exposure to pertussis within the past 8 years.
- If female, "of childbearing potential", sexually active, and had not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry:
- Of childbearing potential was defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
- Acceptable birth control methods were defined as one or more of the following:
- Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring);
- Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse;
- Intrauterine device (IUD);
- Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry.
- If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" through to 3 weeks after last study vaccination.
- Any positive or indeterminate pregnancy test.
- Female individuals who were pregnant or breastfeeding.
- Individuals with contraindications, warnings and/or precautions to vaccination with Boostrix or Td-pur as specified within the summary of product characteristics.
- Individuals with a clinically significant active infection (as assessed by the investigator) or oral body temperature ≥38°C/100.4ºF within 3 days of the intended date of vaccination.
- Known hypersensitivity or allergy to diphtheria, tetanus, or pertussis vaccine (including excipients of the investigational study vaccines, control or placebo as summarized in protocol section 5.0).
- Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, might have interfered with the subject's ability to participate in the study.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Vaccinology (CEVAC), Ghent University Hospital
De Pintelaan, B-9000 Ghent, 185, Belgium
Related Publications (1)
Leroux-Roels G, Lattanzi M, Solis CD, Contorni M, Costantini M, Moraschini L, Bardelli M, Bertholet S, Borgogni E, Buricchi F, Cantisani R, Faenzi E, Finco O, Leuzzi R, Pizza M, Rosa D, Schiavetti F, Seubert A, Spensieri F, Volpini G, Zedda L, Giudice GD, Galgani I. A phase I, randomized, controlled, dose-ranging study of investigational acellular pertussis (aP) and reduced tetanus-diphtheria-acellular pertussis (TdaP) booster vaccines in adults. Hum Vaccin Immunother. 2018 Jan 2;14(1):45-58. doi: 10.1080/21645515.2017.1385686. Epub 2017 Nov 27.
PMID: 29172945DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines
Study Officials
- STUDY CHAIR
Novartis Vaccines
Novartis Vaccines
- PRINCIPAL INVESTIGATOR
Geert Leroux-Roels, Prof. Dr.
Center for Vaccinology (CEVAC), Ghent University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2012
First Posted
February 9, 2012
Study Start
March 1, 2012
Primary Completion
July 1, 2012
Study Completion
July 1, 2013
Last Updated
April 4, 2016
Results First Posted
September 18, 2014
Record last verified: 2016-03