Revaccination With PPS23 Boosted or Not by PCV13 in Splenectomised Patients.

NCT03873727 | Unknown Phase 2 DMC

• 2 other identifiers: P170934J2018-003068-29
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This research is a multi-center French randomized and double blind phase IIb clinical trial evaluating 2 revaccination strategies against pneumococcal infections among splenectomised patients. The main objective is to evaluate at M13 the immunological response of 2 pneumococcal revaccination strategies (combined revaccination by a boost dose of PCV13 following 12 months later by PPS23, versus PPS23 alone) in splenectomised adults.

Conditions

Splenectomised Patients

Keywords

Vaccination / Re-vaccination; Asplenic patient; Splenectomy; Pneumococcal infections; immunological response; Pneumovax; Prevenar13

Outcome Measures

Primary Outcomes (1)

• Immunogenicity

  Immune response at M13 against minimum of 5 of the 9 serotypes analysed (9 serotypes among the 12 common serotypes to both PPS23 and PCV13: 1, 3, 6B, 7F, 9V, 14, 19A, 19F, and 23F) in each arm. A responder to a serotype is defined as a four-fold increase of the rate of OpsonoPhagocytic Assay (OPA) compared to baseline (M0) and titer ≥ Lower Limit of Quantification (LLOQ).

  at Month 13

Secondary Outcomes (12)

• Enzyme-linked immunosorbent assay (ELISA) antibody dosages

  Month 0 to Month 24

• Enzyme-linked immunosorbent assay (ELISA) antibody dosages

  Month 0 to Month 24

• Enzyme-linked immunosorbent assay (ELISA) antibody dosages

  Month 0 to Month 24

• Titration of OPA -

  at Month 0, Month 13 and Month 24

• Titration of OPA -

  at Month 0, Month 13 and Month 24

Study Arms (2)

Prevenar13/ Pneumovax

EXPERIMENTAL

Prime-boost strategy combining a single dose of 13-valent pneumococcal conjugate vaccine (Prevenar 13, PCV13) at month 0 (M0) followed by a single dose of 23-valent unconjugated vaccine (Pneumovax, PPS23) at month 12 (M12).

Biological: Prevenar13 (PCV13) and Pneumovax (PPS23); Biological: Blood sample

Placebo / Pneumovax

PLACEBO COMPARATOR

Standard strategy combining a single dose of placebo vaccine (Prevenar 13 placebo) at month 0 (M0) followed by a single dose of 23-valent unconjugated vaccine (Pneumovax, PPS23) at month 12 (M12)

Biological: Placebo / Pneumovax (PPS23); Biological: Blood sample

Interventions

Prevenar13 (PCV13) and Pneumovax (PPS23) BIOLOGICAL

One dose of PCV13 at Month 0 and one dose of PPS23 at Month 12

Prevenar13/ Pneumovax

Placebo / Pneumovax (PPS23) BIOLOGICAL

One dose of Placebo at Month 0 and one dose of PPS23 at Month 12

Placebo / Pneumovax

Blood sample BIOLOGICAL

an additional 5 mL sample of blood at one of the visits, preferably at the first visit, concerning patients included in Parisian centers who did not participate in SPLENEVAC 1 study.

Placebo / Pneumovax; Prevenar13/ Pneumovax

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Splenectomised patients.
• For patients not enrolled in SPLENEVAC clinical trial: presence of Jolly Body at blood smear and spelenectomy confirmation by abdominal ultrasound.
• Patients must give written informed consent prior to any trial procedure.
• Women of childbearing age must have an effective contraception during the first 13 months of the study.
• Patients must be covered by social security regimen or equivalent.

You may not qualify if:

• History of pneumococcal revaccination in the last five years.
• Having received any another vaccines within 4 weeks prior to enrolment or who is planning to receive any vaccine (for example: ZOSTAVAX®) within the first 13 months of the study (excepted seasonal influenza vaccine which is permitted 4 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up. Furthermore, the vaccination against Sars-CoV-2 is allowed during the study with a minimum interval of 14 days between pneumococcal vaccine and Sars-Cov-2 vaccine injection)
• History of known allergies to any component of both study vaccines (active substances, excipients or diphtheria toxoid).
• History of anaphylactic reaction following vaccination.
• Coagulation disorder contra-indicating intramuscularly injections.
• Immunosuppressive factors associated.
• Enrolment in any other clinical trial during the whole trial period except observational study.
• Adults under protection

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• EUCLID Clinical Trial Platform: collaborator
• Recherche Clinique Paris Descartes Necker Cochin Sainte Anne: collaborator
• CIC 1417 Cochin-Pasteur: collaborator
• I-REIVAC Innovative Clinical Research Network In Vaccinology: collaborator

Study Sites (1)

CIC 1417 Cochin-Pasteur - GH Broca-Cochin-Hôtel-Dieu

Paris, 75014, France

Location

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine; Pneumococcal Vaccines; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Odile Launay, MD,PhD

  CIC 1417 Clinical Center Investigation - Cochin Hospital, AP-HP

  PRINCIPAL INVESTIGATOR

• Olivier Lortholary, Md,PhD

  Service des Maladies Infectieuses et Tropicales, Necker-Enfants malades Hospital, AP-HP

  PRINCIPAL INVESTIGATOR

• Hélène Coignard-Biehler, MD,PhD

  COREB - Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

• Marc Michel, MD,PhD

  Service de médecine interne, Henri Mondor Hospital, APHP

  PRINCIPAL INVESTIGATOR

• Benjamin Rossi, MD

  Service de Médecine interne et de Maladies infectieuses, Robert Ballanger Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: March 13, 2019
• Study Start: August 27, 2019
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)