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

Novartis

Status and phase: Completed; Phase 1

Conditions: Pertussis

Treatments: Biological: Licensed TdaP booster (Boostrix®); Biological: TdaP booster; Biological: aP booster

Study type: Interventional

Funder types: Industry

Identifiers

NCT02382913

V113_01E1

2014-003729-16 (EudraCT Number)

Details and patient eligibility

About

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 Approximately 10.0 mL of blood was withdrawn.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.

Enrollment: 315 patients

Sex: All

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

315 participants in 10 patient groups

Group 1

Experimental group

Description:

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.

Treatment:

Biological: aP booster

Group 2

Experimental group

Description:

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.

Treatment:

Biological: aP booster

Group 3

Experimental group

Description:

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

Treatment:

Biological: aP booster

Group 4

Experimental group

Description:

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.

Treatment:

Biological: TdaP booster

Group 5

Experimental group

Description:

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.

Treatment:

Biological: TdaP booster

Group 6

Experimental group

Description:

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.

Treatment:

Biological: TdaP booster

Group 7

Experimental group

Description:

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.

Treatment:

Biological: TdaP booster

Group 8

Experimental group

Description:

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

Treatment:

Biological: TdaP booster

Group 9

Experimental group

Description:

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.

Treatment:

Biological: TdaP booster

Group 10

Active Comparator group

Description:

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

Treatment:

Biological: Licensed TdaP booster (Boostrix®)