Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1)

Phase 1

Completed

• Conditions: Pertussis
• Interventions: Biological: aP booster; Biological: TdaP booster; Biological: Licensed TdaP booster (Boostrix®)

• Registration Number: NCT02382913
• Lead Sponsor: Novartis

Brief Summary

The purpose of this study is to evaluate the persistence of immune response against the three pertussis antigens (anti- pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN)) in subjects who received a booster dose of either aP or Tdap study vaccines or Boostrix® during V113_01 study.

There was only one Clinic Visit at day 1. Eligible subjects went undergo a single blood draw after which they were observed for approximately 15 minutes. Approximately 10.0 mL of blood was withdrawn.

No vaccine was administered and no safety data was collected in this study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-03-06
• Study First Posted: 2015-03-09
• Study Start: 2015-04
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2016-01-14
• Results First Submitted QC: 2016-01-14
• Status Verified: 2016-02
• Results First Posted: 2016-02-12
• Last Update Submitted: 2016-02-24
• Last Update Posted: 2016-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

Inclusion Criteria

• Healthy individuals previously enrolled in V113_01 trial, who completed the study following study protocol and who received the appropriate booster vaccine per group assignment
• Individuals who voluntarily gave written informed consent after the nature of the study was explained according to local regulatory requirements, prior to study entry
• Individuals who could comply with study procedures including follow-up

Exclusion Criteria

1. Clinical conditions representing a contraindication to blood draw.

2. Abnormal function of the immune system resulting from:

   • Clinical conditions
   • Systemic administration of corticosteroids per oral (PO)/ intravenous (IV)/ intramuscular (IM) for more than 14 consecutive days within 90 days prior to informed consent.
   • Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.

3. Received immunoglobulins or any blood products within 180 days prior to informed consent.

4. Received an investigational or non-registered medicinal product within 30 days prior to informed consent

5. Study personnel as an immediate family or household member

6. Any other clinical condition that, in the opinion of the investigator, could interfere with the results of the study or pose additional risk to the subject due to participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	aP booster	Subjects 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	Subjects 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 7	TdaP booster	Subjects 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 1	aP booster	Subjects 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 4	TdaP booster	Subjects 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 10	Licensed TdaP booster (Boostrix®)	Subject 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
Group 5	TdaP booster	Subjects 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	Subjects 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 9	TdaP booster	Subjects 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 8	TdaP booster	Subjects 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

Primary Outcome Measures

Name	Time	Method
Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1.	Day 1	The antibody response against the pertussis antigen components (PT, FHA and PRN) at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in aP1, aP2, aP4 Groups versus the response to the commercially available Tdap comparator.; Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1.	Day 1	The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D2aP1, T5D2aP2 and T5D2aP4 Groups versus the response to the commercially available Tdap comparator.; Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1.	Day 1	The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D4aP1, T5D4aP2 and T5D4aP4 Groups versus the response to the commercially available Tdap comparator.; Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.	Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1	Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1.; Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.	Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1	Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1.; Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.	Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1	Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1.; Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.

Trial Locations

Locations (1)

Site 02, Center for Vaccinology (CEVAC), Ghent University Hospital; 🇧🇪 Ghent, Belgium