A Study of a Vaccine for Pneumonia in Adults and Toddlers in Kenya

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02543892
• Date of registration: 01/09/2015
• Prospective Registration: Yes
• Primary sponsor: PATH
• Public title: A Study of a Vaccine for Pneumonia in Adults and Toddlers in Kenya
• Scientific title: Phase 1-2 Safety and Immunogenicity Study of PATH-wSP in Kenyan Adults and Toddlers
• Date of first enrolment: August 10, 2016
• Target sample size: 248
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02543892
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Kenya

Contacts

• Name: Anthony Scott, MD
• Affiliation: London School of Hygiene and Tropical Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy adults who are 18 to 40 years old, or toddlers who are 12 to 19 months old.

- Must provide voluntary written/thumb-printed informed consent

- Must comply with study requirements and procedures.

- Must have an identifiable place of residence to allow home visits, and a consistent
means of telephone contact

- Must be resident in the study area with no plans to travel outside the study area
during the study

- Must be willing to not take herbal or other local traditional medications within 28
days of randomization and during the course of the study

- Adult female subjects must have a negative serum pregnancy test at screening and urine
pregnancy test prior to each vaccination

- Toddlers must have been born full-term, and have a mid-upper arm circumference > 11.5
cm at the time of enrollment.

- Toddlers must have completed their Kenyan infant EPI schedule through 9 months
including 1 birth dose of BCG, 3 doses of DTwPHibHep, 3 doses of OPV (birth dose is
not required), 3 doses of PCV, and 1 dose of measles vaccine

Exclusion Criteria:

- Use of any investigational or nonregistered drug within 90 days of enrollment

- Use of any potentially hepatotoxic drug

- Receipt of any licensed vaccine within 14 days of administration of study vaccine.

- Chronic, clinically significant pulmonary, cardiovascular, hepatobiliary,
gastrointestinal, renal, neurological, or hematological functional abnormality or
major congenital defects or illness that requires medical therapy, based on medical
history or clinical assessment

- History of anaphylactic shock

- History of a serious reaction to any prior vaccination or known hypersensitivity to
any component of the study vaccines

- History of immunosuppression or immunodeficiency, inclusive of human immunodeficiency
virus (HIV) infection by medical history (including that of an enrolled toddler's
mother) or by HIV testing at screening

- Evidence of active hepatitis infection (B or C) by serologic testing at screening.

- Any screening laboratory test (chemistry or hematology) or vital sign measurement with
toxicity grade = 1

- Acute illness (moderate or severe) and/or fever (axillary temperature = 37.5°C)

- Positive test for malaria (blood film) at screening that remains positive post
treatment when retested prior to vaccination

- Disorders that require chronic administration (defined as more than 14 consecutive
days) of immunosuppressants or other immune-modifying drugs within the past 6 months
prior to the administration of the study vaccine.

- Administration of immunoglobulins and/or any blood products within the 6 months
preceding enrollment in the study

- Known disturbance of coagulation or other blood disorder (e.g., thalassemia, sickle
cell disease, thrombocytopenia, disorders of the lymphocytes, severe anemia at birth)
in adult subject or in self/first-degree relative of toddler subject; or receipt of
anticoagulants in the past three weeks (aspirin as needed and nonsteroidal
anti-inflammatory drugs are acceptable)

- History of meningitis, seizures or any neurological disorder (all participants) or
major psychiatric disorder (adults)

- Any medical or social condition that in the opinion of the investigator will interfere
with the study objectives or pose a risk to the study subject

- An employee (or first-degree relative of employee) of the Sponsor, the CRO, or any
investigator or site personnel

- Female adult subjects who are pregnant or breast-feeding

- Adults with a recent history (within the past year) of alcohol or substance abuse.

- Toddlers who have already received a pentavalent booster (following the primary
series).

- Toddlers with a family history of suspected primary immunodeficiency in first-degree
relative.

- Toddlers who had a sibling die of likely sudden infant death syndrome (SIDS) or die
suddenly and without apparent other cause or preceding illness in the first year of
life.

- Toddlers with evidence of a clinically significant congenital abnormality as judged by
the PI.

- Toddlers with evidence of fetal alcohol syndrome or maternal history of alcohol abuse
during pregnancy



Age minimum: 1 Year
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pneumonia

Intervention(s)

Biological: PATH-wSP

Biological: Placebo

Primary Outcome(s)

Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1 [Time Frame: 7 days after the first dose (Day 7)]

Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2 [Time Frame: 7 days after the second dose (Day 35)]

Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2 [Time Frame: 7 days after the second dose (Day 35)]

Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1 [Time Frame: 7 days after the first dose (Day 7)]

Number of Adverse Events (AE), by Relation to Vaccine and Seriousness [Time Frame: 112 days]

Secondary Outcome(s)

Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins [Time Frame: Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)]

Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins [Time Frame: Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)]

Number of Subjects With Immunoglobulin G (IgG) Seroresponse [Time Frame: Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)]

Secondary ID(s)

VAC-040

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/11/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02543892