NCT04974294

Brief Summary

To determine the effect of PCV-13 and PPV-23 vaccination versus control on experimental pneumococcal colonisation of 2 clades of serotypes 3 and 6B at 1 month and 6 months post vaccination respectively, using the EHPC model.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
516

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2021

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

July 28, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

July 21, 2021

Last Update Submit

January 3, 2023

Conditions

Streptococcus Pneumonia

Outcome Measures

Primary Outcomes (1)

  • The rate of experimental pneumococcal colonisation with SPN3 determined by the presence of pneumococcus in nasal wash (NW) by classical culture or molecular methods

    The rate of experimental pneumococcal colonisation with SPN3 determined by the presence of pneumococcus in nasal wash (NW) by classical culture or molecular methods at any time point during 23 days following experimental human pneumococcal challenge (EHPC) 1 month after vaccination in the PCV-13, PPV-23 and control groups.

    any time point during 23 days following experimental human pneumococcal challenge (EHPC) 1 month after vaccination in the PCV-13, PPV-23 and control groups.

Study Arms (3)

PPV23

ACTIVE COMPARATOR
Biological: PPV23

PCV13

ACTIVE COMPARATOR
Biological: PCV13

Saline placebo

PLACEBO COMPARATOR
Other: Saline for injection

Interventions

PPV23BIOLOGICAL

random allocation 1:1:1 IM injection

Also known as: pneumovax
PPV23
PCV13BIOLOGICAL

random allocation 1:1:1 IM injection

Also known as: prevenar
PCV13
Saline for injectionOTHER

random allocation 1:1:1 IM injection

Saline placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 18-50 years (inclusive)
  • Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement
  • Capacity to provide written informed consent
  • Females of childbearing potential with a negative urine pregnancy test at screening and willing to practice adequate birth control measures during the study.

You may not qualify if:

  • Be currently involved in another study unless observational or non-interventional. Exceptions are the EHPC bronchoscopy study and COVID-19 observational and interventional trials. The exceptions will be applied at the discretion of the Chief Investigator to ensure no harm comes to the participants (e.g. excessive blood sampling)
  • Be a participant in a previous EHPC trial within the last 3 years (at the discretion of the study team).
  • Vaccination (self-reported or confirmed from GP questionnaire \[GPQ\] or medical summary if deemed necessary at clinician discretion): Have had any previous pneumococcal vaccination (including in a research study).
  • Allergy:
  • Have allergy to penicillin or amoxicillin.
  • Have previous anaphylaxis or severe adverse reaction to any component/excipient of the vaccines or to any vaccine.
  • Health history (self-reported by the participant or confirmed in GPQ or medical summary if deemed necessary at clinician discretion): Ill health including but not limited to:
  • Asplenia or dysfunction of the spleen.
  • Chronic respiratory disease (e.g. asthma \[on medication\], COPD, emphysema, bronchiectasis).
  • Chronic heart disease (e.g. angina, ischaemic heart disease, chronic heart failure) \[controlled stable hypertension may be included\].
  • Chronic kidney disease (e.g. nephrotic syndrome, kidney transplant, on dialysis).
  • Chronic liver disease (e.g. cirrhosis, biliary atresia, hepatitis).
  • Chronic neurological conditions
  • Connective tissue disease
  • Dementia
  • +28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool School of Tropical Medicine

Liverpool, United Kingdom

RECRUITING

Related Publications (1)

  • Liatsikos K, Hyder-Wright A, Pojar S, Chen T, Wang D, Davies K, Myerscough C, Reine J, Robinson RE, Urban B, Mitsi E, Solorzano C, Gordon SB, Quinn A, Pan K, Anderson AS, Theilacker C, Begier E, Gessner BD, Collins A, Ferreira DM; PNEUMO 2 study group. Protocol for a phase IV double-blind randomised controlled trial to investigate the effect of the 13-valent pneumococcal conjugate vaccine and the 23-valent pneumococcal polysaccharide vaccine on pneumococcal colonisation using the experimental human pneumococcal challenge model in healthy adults (PREVENTING PNEUMO 2). BMJ Open. 2022 Jul 7;12(7):e062109. doi: 10.1136/bmjopen-2022-062109.

    PMID: 35798520DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Pneumococcal VaccinesHeptavalent Pneumococcal Conjugate VaccineSodium ChlorideInjections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, CombinedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsDrug Administration RoutesDrug TherapyTherapeutics

Central Study Contacts

Kelly Davies

CONTACT

+44 151 702 9391kelly.davies@lstmed.ac.uk

Angela Hyder- Wright

CONTACT

07540 976 888Angela.Hyder-Wright@lstmed.ac.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants will remain blinded until the completion of the last participant, last study visit (Day 23: 7-month challenge). As the appearance of the vaccines are different, physical blindfolds may be worn by the participant to maintain blinding. This method of blinding has been used by our team previously and the time wearing the blindfold is kept to an absolute minimum for participant comfort. Un-blinded clinical team members will prepare and administer the vaccines/placebo to the participants in a blinded manner, shielding the vaccine formula, syringe and box from the participant when it is administered. The vaccine will be checked and prepared in a separate room to the participant and in a separate location to the blinded team. The participant will be seated in the vaccination room, the un-blinded clinical members will enter the vaccination room immediately prior to administration. Local SOPs will be followed to ensure appropriate participant team blinding.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: double blind RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2021

First Posted

July 23, 2021

Study Start

July 28, 2021

Primary Completion

July 31, 2023

Study Completion

December 31, 2023

Last Updated

January 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)