A phase 4, randomised vaccination study in healthy adults to investigate the effects of acellular pertussis vaccine on colonisation with Bordetella pertussis using controlled human infection (KIM-study)

2023-508416-35-00 Protocol PaNaMa ID: 114794 Therapeutic use (Phase IV) Ongoing, recruitment ended

Start 16 Oct 2024 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 1 sites · Protocol PaNaMa ID: 114794

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruitment ended
Participants planned 99
Countries 1
Sites 1

Pertussis or 'whooping cough'

To investigate whether booster vaccination with Tdap-IPV reduces Bp colonisation after intranasal challenge with the standard Bp inoculum dose compared to the Td-IPV control group

Key facts

Sponsor
Stichting Radboud University Medical Center
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Bacterial Infections and Mycoses [C01]
Trial duration
16 Oct 2024 → ongoing
Decision date (initial)
2024-06-04
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To investigate whether booster vaccination with Tdap-IPV reduces Bp colonisation after intranasal challenge with the standard Bp inoculum dose compared to the Td-IPV control group

Conditions and MedDRA coding

Pertussis or 'whooping cough'

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. Participant is born before 1-9-2004 and < 50 years old on the day of screening (Visit 1; V1)
  2. Participant has received all primary pertussis vaccines during childhood
  3. Participant is able to answer all questions of the pre-consent questionnaire correctly
  4. Participant is fully conversant in the Dutch language
  5. Participant is able to arrive within 1h at the Radboudumc from his/her home address. The participant must have a home address and live in the Netherlands
  6. Participant is able to arrive within 3h at the Radboudumc at any time between Bp inoculation (V6) until the day 28 post challenge visit (V12)
  7. Participant is willing to take an antibiotic regimen after inoculation with Bp according to the study protocol

Exclusion criteria 8

  1. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention
  2. Smoking: Any smoking event in the last month, including (e-)cigarette, joint, cigar and pipe
  3. Individuals who have a history of receiving pertussis vaccination in the last 5 years
  4. Receipt of any non-study vaccine within 14 days, before and after receiving the study vaccine (V2) or Bp inoculation (V6)
  5. For female participants: pregnancy, lactation or intention to become pregnant during the study. Female volunteers are required to use an effective form of contraception during this study
  6. Individuals who have inviolable commitments within the study period from V6 until V12 (28 days in total) to make contact with: • infants aged < 1 year • unimmunized children aged < 4 years • pregnant women >32 weeks who have not received pertussis vaccination at least a week prior to contact • chronically ill patients (e.g. asthma, COPD, heart diseases)
  7. Individuals who have household contacts working with • infants aged < 1 year • pregnant women
  8. A confirmed diagnosis of pertussis in the last two years and/or Serum IgG anti-FHA >55.9 IU/mL

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. Bp colonisation rate in Tdap-IPV and Td-IPV vaccination groups, with Bp colonisation defined as any positive Bp culture from nasal wash samples at any time point between Day 3 and Day 28 after challenge
  2. Bp colonisation rate in Tdap-IPV vaccination groups, with Bp colonisation defined as any positive Bp culture from nasal wash samples at any time point between Day 3 and Day 28 after challenge

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

REPEVAX, suspension for injection, in pre-filled syringe Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content)

PRD9046697 · Product

Active substance
Diphtheria Toxoid
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07CA02 — DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS
Marketing authorisation
PL 46602/0005
MA holder
SANOFI PASTEUR EUROPE
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 1

REVAXIS Suspensie voor injectie in voorgevulde spuit. Difterie, tetanus en poliomyelitis (geïnactiveerd) vaccin, geadsorbeerd, beperkte hoeveelheid antigen(en).

PRD4462240 · Product

Active substance
Diphtheria Toxoid
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07CA01 — DIPHTHERIA-POLIOMYELITIS-TETANUS
Marketing authorisation
RVG 24534
MA holder
SANOFI PASTEUR EUROPE
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Auxiliary 1

Azitromycine 500 mg Teva, filmomhulde tabletten.

PRD689348 · Product

Active substance
Azithromycin
Substance synonyms
AZITROMICINA
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
500 mg milligram(s)
Max total dose
1500 mg milligram(s)
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
J01FA10 — AZITHROMYCIN
Marketing authorisation
RVG 28934
MA holder
TEVA NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Radboud University Medical Center

21 Total trials 11 Recruiting 9 Ended
Academic / Non-commercial
Sponsor organisation
Stichting Radboud University Medical Center
Address
Geert Grooteplein Zuid 10
City
Nijmegen
Postcode
6525 GA
Country
Netherlands

Scientific contact point

Organisation
Stichting Radboud University Medical Center
Contact name
Dimitri Diavatopoulos

Public contact point

Organisation
Stichting Radboud University Medical Center
Contact name
Dimitri Diavatopoulos

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ongoing, recruitment ended 99 1
Rest of world — 0 —

Investigational sites

Netherlands

1 site · Ongoing, recruitment ended
Radboud universitair medisch centrum / RADBOUDUMC
Laboratory Medical Immunology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Netherlands 2024-10-16 2024-10-16 2026-03-25

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 24 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1 protocol KIM trial_for publication 7.1
Protocol (for publication) D4a Aanmeldformulier KIM studie_for publication 1
Protocol (for publication) D4b Pre-screening telefoon vragenlijst_for publication 3
Protocol (for publication) D4b Pre-screening telefoon vragenlijst_for publication trackchanges 3
Protocol (for publication) D4c Huisartsenbrief_for publication 1
Protocol (for publication) D4d Deelnemerskaart_for publication 2
Protocol (for publication) D4e Klachtendagboek_for publication 1
Protocol (for publication) D4f Preconsent questionnaire_for publication 2
Protocol (for publication) D4f Preconsent questionnaire_for publication_trackchanges 2
Protocol (for publication) D4g Vragenlijst vaccinatie_for publication 1
Protocol (for publication) E1 IB BP_B1917 clean_for publication 2
Protocol (for publication) E1 IB BP_B1917 trackchanges_for publication 2
Protocol (for publication) J2 challenge agent label clean_for publication 2
Protocol (for publication) J2 challenge agent label trackchanges_for publication 2
Recruitment arrangements (for publication) K1 Recruitment procedure_for publication 1
Recruitment arrangements (for publication) K2a_Recruitment flyer KIM_for publication 2
Recruitment arrangements (for publication) K2b_Recruitment folder KIM_for publication 2
Recruitment arrangements (for publication) K2c Recruitment material Uitnodigingsbrief_for publication 2
Recruitment arrangements (for publication) K2d_Recruitment flyer klein_for publication 2
Subject information and informed consent form (for publication) L1_SIS and ICF description_for publication 4.1
Summary of Product Characteristics (SmPC) (for publication) G2 Revaxis SmPC 1
Summary of Product Characteristics (SmPC) (for publication) G3 Repevax SmPC 1
Synopsis of the protocol (for publication) D1 Protocol KIM trial ENG synopsis_for publication 1
Synopsis of the protocol (for publication) D1 Protocol KIM trial NL synopsis_for publication 1

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-02-23 Netherlands Acceptable with conditions
2024-06-04
 2024-06-04
2 SUBSTANTIAL MODIFICATION SM-1 2024-07-19 Netherlands Acceptable
2024-09-23
 2024-09-23
3 SUBSTANTIAL MODIFICATION SM-2 2025-02-05 Netherlands Acceptable
2025-03-18
 2025-03-18
4 SUBSTANTIAL MODIFICATION SM-3 2025-10-31 Netherlands Acceptable
2026-01-26
 2026-01-26