Pneumococcal Infection Clinical Trial
— FPCVOfficial title:
The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines (PCV10 and PCV13) on Immunogenicity and Vaccine-serotype Carriage in Kenyan Infants
Verified date | March 2023 |
Source | London School of Hygiene and Tropical Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Before the introduction of pneumonia vaccines in 2000, between 700,000 - 1 million children died each year as a result of infection with the bacteria Streptococcus pneumoniae and the resulting diseases, namely, meningitis, sepsis and pneumonia. Most of the deaths were in Africa and Asia. Where the vaccines have been introduced, they have been highly effective and have already reduced disease. However, at 10 USD per child, they are not affordable to most low-income countries without financial support from Gavi, the Vaccine Alliance. This project aims to assess whether lower doses of the two commercially available pneumonia vaccines can protect Kenyan infants as well as the full dose. The results could be used to increase the affordability of the pneumonia vaccine, and enable delivery of the vaccine to continue in the absence of Gavi support.
Status | Active, not recruiting |
Enrollment | 2100 |
Est. completion date | December 30, 2024 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Weeks to 8 Weeks |
Eligibility | Inclusion Criteria: - Healthy infants aged 6-8 weeks of age (HIV positive or negative but with no symptoms of current clinical immunosuppression i.e. HIV infection at WHO clinical stage 1); - Parents are willing to provide informed consent for their child to participate in the study - Parents and infant are likely to remain in the study area until the infant is 18 months of age and comply with study requirements including the requirement to return to the same health facility to obtain all other childhood vaccines. Exclusion Criteria: - Infants >8 weeks of age at time of enrolment - Signs or symptoms of immunosuppression or HIV infection clinical stage 2 or above. - Acute illness (e.g. febrile disease) on the day of vaccination - Contraindications precluding vaccination (e.g. hypersensitivity to any component of the vaccine, including diphtheria toxoid) - Previous PCV vaccination - Family are planning to migrate out of the study areas before the end of the study follow-up - Family are planning to obtain the subsequent vaccine doses of the routine immunisation schedule elsewhere and therefore their child may receive a full dose under the routine vaccination programme. |
Country | Name | City | State |
---|---|---|---|
Kenya | KEMRI Wellcome Trust Research Programme | Kilifi |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine | Bill and Melinda Gates Foundation, KEMRI-Wellcome Trust Collaborative Research Program, National Institute of Health Research (NIHR) Mucosal Pathogens Research Unit (MPRU), University College, London, Wellcome Trust |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Immunogenicity: the geometric mean concentration (GMC) of serotype-specific IgG | IgG GMCs elicited post-primary series | 4-weeks post-primary series (approximately 18 weeks of age) | |
Other | Safety: the prevalence of adverse events following immunisation by arm | The proportion fo children with adverse events following immunisation by arm | Infants 6weeks-18 months of age | |
Other | Immunogenicity: The geometric mean concentration (GMC) of serotype-specific IgG after the primary series of the 2p+1 schedule, prior to boost (9 months of age) and at the end of study follow-up at 18 months of age. | IgG GMCs at 9 and 18 months of age | Approximately 9 and 18 months of age | |
Primary | Immunogenicity: The ratio of IgG GMCs at 1-month post boost | The ratio of the geometric mean concentrations of IgG after vaccination with 3 full or fractional doses of PCV | 4-weeks post-boost (approximately 10 months of age) | |
Secondary | Immunogenicity: the proportion of children who 'seroconvert' to vaccine-serotypes after vaccination | The proportion of children with vaccine-serotype specific IgG antibody concentrations more than or equal to 0.35 mcg/ml after vaccination | 4-weeks post-primary series (approximately 18 weeks of age) | |
Secondary | The proportion of children with evidence of vaccine-serotype carriage | Vaccine-type carriage prevalence across arms | Approximately 18 months of age | |
Secondary | The proportion of children with evidence of vaccine-serotype carriage | Vaccine-type carriage prevalents across arms | Approximately 9 months of age | |
Secondary | The direct vaccine effectiveness of full/fractional doses of PCV13 against carriage of serotypes 6A and 19A | The direct effectiveness of full/fractional doses of PCV13 in preventing carriage of serotypes 6A and 19A compared to that of full dose PCV10 | Approximately 18 months of age | |
Secondary | Opsonophagocytic activity of vaccine-induced antibody to 4 serotypes | Functionality of the antibody response | Approximately 18 months of age |
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