Mass Campaigns With Fractional Dose Pneumococcal Vaccines in Sub-Saharan Africa (fPCV) (fPCV)
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| ClinicalTrials.gov Identifier: NCT05175014 |
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Recruitment Status :
Active, not recruiting
First Posted : January 3, 2022
Last Update Posted : September 22, 2023
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| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | December 13, 2021 | |||||||||
| First Posted Date ICMJE | January 3, 2022 | |||||||||
| Last Update Posted Date | September 22, 2023 | |||||||||
| Actual Study Start Date ICMJE | December 30, 2021 | |||||||||
| Actual Primary Completion Date | May 31, 2023 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Effect of a Single Dose PCV10 Campaign in the Reduction of VT Carriage [ Time Frame: During three months of vaccination campaign, and 6 months post-vaccination campaign ] 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.
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Mass Campaigns With Fractional Dose Pneumococcal Vaccines in Sub-Saharan Africa (fPCV) | |||||||||
| Official Title ICMJE | Determining Whether Mass Campaigns With Fractional Dose PCV10 Would Accelerate Herd Protection Against Pneumococcal Transmission in Sub-Saharan Africa | |||||||||
| 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. | |||||||||
| Detailed Description | In 2015, there were an estimated 8.9 million cases (uncertainty range 7.7-10.6 million) of clinical pneumococcal pneumonia globally, with 2.4 million cases estimated in Africa alone (uncertainty range 2.1-3.1 million). These figures represent a global reduction of 37% from 14.2 million cases (12.3 million-16.9 million) in 2000. However, pneumococcal disease continues to be a leading cause of severe disease and death representing 10% of all death in children under 5 years of age (1). These deaths occur disproportionally in low- and middle-income countries (LMICs), with approximately 50% of global pneumococcal deaths estimated to occur in 4 countries: India, Nigeria, Pakistan and the Democratic Republic of Congo. Vaccination campaigns targeting children up to 5 years of age have an effect in the reduction of VT carriage disease. However, in crises or settings with high prevalence of malnutrition, the high pneumococcal carriage prevalence is likely to extend to older age groups. Single dose vaccination of a larger age group might be needed to control VT circulation. Currently, for GAVI-supported countries such as Niger, PCV13 vaccine has a cost of US$3 per dose. Pneumosil®, a PCV10 manufactured by Serum institute of India Ltd has the lowest price of all WHO prequalified vaccines, at US$2 per dose. Mass campaigns targeting large groups require many doses and might not be sustainable over time. Fractional doses of PCV could be a solution to overcome the high PCV costs, increase vaccine access and expand vaccination benefits through alternative strategies. The study population (ages 1-9) stems from an LSHTM modelling study. Objectives of the study Primary objective: evaluate whether the full dose of PCV is superior to the absence of vaccine and then if a single 20% dose of PCV is non-inferior to a full dose in carriage reduction. Secondary objectives:
Note: the 1-9 years age group targeted for the mass campaign is based on data from a model in Kilifi, Kenya. Baseline carriage survey data together with data will be used on interactions between age groups and PCV coverage data collected during the baseline survey, to estimate the age group that should be targeted for vaccination. Methodology A cluster-randomized, blinded, non-inferiority trial will be implemented in rural villages of the Madarounfa District of Niger. Clusters will be randomized to full dose, fractional dose or control arm in 2:2:1 allocation ratio. Clusters will be composed of a village or group of neighbouring villages that share a school or market. Stratified randomization will be used to consider size of clusters and proximity to health centre. Vaccination will target all children aged approximately 1 to 9 years of age residing in the selected villages Prior to the mass vaccination campaign, a cross-sectional survey will be implemented to estimate community-level carriage of VT pneumococci, as well as to collect data on household composition, social interactions and PCV vaccination coverage. |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 4 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: A Phase IV, 3-arm, observer-blinded, cluster-randomized controlled trial Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Vaccinators will not be blinded, but participants will not know vaccine dosage allocation. Laboratory staff (outcome assessors) will be blinded to their group allocation. Primary Purpose: Prevention
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| Condition ICMJE | Pneumococcal Carriage | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Active, not recruiting | |||||||||
| Actual Enrollment ICMJE |
32000 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | December 31, 2023 | |||||||||
| Actual Primary Completion Date | May 31, 2023 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | For participation in pneumococcal carriage surveys: Inclusion criteria:
Exclusion criteria:
For participation in mass vaccination campaigns (with full or fractional dose PCV10) Inclusion criteria:
Exclusion criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 1 Year to 9 Years (Child) | |||||||||
| Accepts Healthy Volunteers ICMJE | Yes | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Niger | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT05175014 | |||||||||
| Other Study ID Numbers ICMJE | fPCV | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Current Responsible Party | Epicentre | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor ICMJE | Epicentre | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Epicentre | |||||||||
| Verification Date | September 2023 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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