Mass Campaigns With Fractional Dose Pneumococcal Vaccines in Sub-Saharan Africa (fPCV)

NCT05175014 | Completed Phase 4 Results DMC

• 1 other identifier: fPCV
• Study Type: interventional
• Target: 44,618
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the impact of a mass campaign with a single, fractional dose of Pneumosil®, a PCV10, on VT carriage. A 20% fractional dose (1/5th) will be used as a practical formulation to prepare and administer. This study will assess whether the impact of a single fractional dose mass campaign on carriage is non-inferior to a single full dose mass campaign in a cluster randomized trial in a low coverage setting in Niger. The results would provide evidence of the population-level direct and indirect impact of fractional dose in older children which will be completed by mathematical modelling, to inform the policy debate regarding PCV dosing schedules in different contexts. This trial and the modelling exercises that follow, would allow for larger scale evaluation of fractional dose PCV strategies in multiple contexts.

Conditions

Pneumococcal Carriage

Outcome Measures

Primary Outcomes (1)

• Effect of a Single Dose PCV10 Campaign in the Reduction of VT Carriage

  The effect of a single dose PCV10 campaign in the reduction of VT carriage will be assessed by: first, assessing the superiority of a campaign using full doses of PCV10 compared to control group without vaccination; and second, by establishing the non-inferiority of a campaign using fractional doses of PCV10 compared to a campaign using full doses. NP carriage will be measured in the 3 study arms (full dose arm, fractional dose arm and control arm) in a baseline survey implemented prior to the vaccination campaign and in a post-vaccination survey. The NP carriage of VT S. pneumoniae will be measured as the proportion of participants that are colonized with any of the 10 serotypes covered by PCV10 at each time point. The reduction in NP carriage will be calculated by comparing the proportion of children carrying VT pneumococci 6 months post-vaccination to baseline, at the time of vaccination. The prevalence of colonization of non-VT serotypes will also be described at both timepoints.

  During three months of vaccination campaign, and 6 months post-vaccination campaign

Secondary Outcomes (3)

• Vaccine Safety Monitoring

  Up to 28 days after vaccination

• Cost-effectiveness and Modeling

  Within 2 years of study start.

• Facilitators and Barriers to Implementing Mass Campaigns of Fractional Dose PCV

  Within 2 years of study start.

Study Arms (3)

Single full dose of PCV 10

EXPERIMENTAL

27 clusters randomized to receive a vaccination campaign with the full dose.

Biological: PCV10 full dose

Single fractional dose of PCV10 (1/5)

EXPERIMENTAL

27 clusters randomized to receive a vaccination campaign with the fractional dose (1/5).

Biological: PCV10 fractional dose

Control Group

NO INTERVENTION

9 clusters randomized to the control arm.

Interventions

PCV10 full dose BIOLOGICAL

Mass vaccination campaign with one single dose PCV10 vaccine administered as a full dose.

Single full dose of PCV 10

PCV10 fractional dose BIOLOGICAL

Mass vaccination campaign with one single dose PCV10 vaccine administered as a fractional dose.

Single fractional dose of PCV10 (1/5)

Eligibility Criteria

• Age: 1 Year - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged 1-9 years
• Residing in the villages included in the study
• Parent or caretaker provides informed consent for the child to participate in the study

You may not qualify if:

• Head or facial injuries that contraindicate nasopharyngeal swabbing
• Any condition or criteria, including acute or chronic clinically significant abnormality that in the opinion of the investigator might compromise the wellbeing of the participant or interfere with the outcome of the study
• For participation in mass vaccination campaigns (with full or fractional dose PCV10)
• Aged 1-9 years
• Residing in the villages included in the study and allocated to vaccination
• Head of the household or main caretaker provides consent for the child to be vaccinated
• Hypersensitivity to any component of the vaccine, including diphtheria toxoid
• Vaccination with a PCV vaccine within the previous 4 weeks, as there should be a minimum of 4 weeks between doses
• Moderate or severe febrile illness (temperature ≥39°C) is a temporal contraindication and the child should not be vaccinated until improvement
• Any condition or criteria, including acute or chronic clinically significant abnormality that in the opinion of the clinical staff might compromise the wellbeing of the volunteer

Sponsors & Collaborators

• Epicentre: lead
• London School of Hygiene and Tropical Medicine: collaborator
• Kenya Medical Research Institute: collaborator
• Universite Abdou Moumouni de Niamey, Niger: collaborator

Study Sites (1)

Epicentre

Maradi, Niger

Location

Related Publications (1)

• Coldiron ME, Soumana I, Baudin E, Langendorf C, Mamiafo Tchoula C, Brah S, Karani A, Gallagher KE, Kagucia EW, Scott JAG, Grais RF. Effect of mass campaigns with full and fractional doses of pneumococcal conjugate vaccine (Pneumosil) on the reduction of nasopharyngeal pneumococcal carriage in Niger: a three-arm, open-label, cluster-randomised trial. Lancet Infect Dis. 2025 Jun;25(6):634-642. doi: 10.1016/S1473-3099(24)00719-9. Epub 2025 Jan 8.

  PMID: 39798587 DERIVED

Results Point of Contact

• Title: Dr Matthew E Coldiron
• Organization: Epicentre

matthew.coldiron@epicentre.msf.org

+33 1 40 21 55 55

Study Officials

• Dr. Rebecca Grais

  Epicentre Research Department Director

  STUDY DIRECTOR

• Dr. Matthew Coldiron

  Epicentre Research Department Investigator

  PRINCIPAL INVESTIGATOR

• Dr. Issaka Soumana

  Epicentre Niger Research Center Assistant Manager

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Vaccinators will not be blinded, but participants will not know vaccine dosage allocation. Laboratory staff (outcome assessors) will be blinded to their group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Phase IV, 3-arm, observer-blinded, cluster-randomized controlled trial

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 3, 2022
• Study Start: December 30, 2021
• Primary Completion: March 14, 2023
• Study Completion: October 3, 2023
• Last Updated: December 5, 2024
• Results First Posted: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: De-identified IPD will be available after final data collection and cleaning, and once laboratory quality control procedures have been conducted.
• Access Criteria: Any interested party may request access to the data for the purposes of secondary analysis or meta-analysis. The process for requesting data, and the criteria upon which requests will be judged are described in Epicentre Standard Operating Procedures.

Locations

NI (1)