Nasopharyngeal Carriage Study in Healthy Kenyan Toddlers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02146365
• Date of registration: 21/05/2014
• Prospective Registration: Yes
• Primary sponsor: PATH
• Public title: Nasopharyngeal Carriage Study in Healthy Kenyan Toddlers
• Scientific title: A Prospective Study to Assess the Nasopharyngeal Carriage of Streptococcus Pneumoniae (SPn), Long Term Safety and Immune Persistence in Healthy Kenyan PCV-Primed Toddlers (12-15 Months of Age) Who Received a Whole Cell Pneumococcal Vaccine (PATH-wSP) Compared to Controls
• Date of first enrolment: September 25, 2014
• Target sample size: 297
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02146365
• Study type: Observational

Countries of recruitment

Kenya

Contacts

• Name: Nekoye Otsyula, MB ChB MSc
• Affiliation: Kenya Medical Research Institute/Walter Reed Project

Key inclusion & exclusion criteria

Inclusion Criteria:

- For Toddlers Enrolled in VAC-010 (NCT02097472):

- Randomization in VAC-010.

- Subject's parent must provide voluntary written informed consent for subject to
participate in the study, is fully capable of comprehending and complying with study
requirements and procedures, able and willing to return for all scheduled follow-up
visits, and has expressed availability for the required study period, with access to a
consistent means of telephone contact. An illiterate parent will require an impartial
witness to be present during consenting process to include discussing the consent
form, verbal consent and thumb-printing.

- Subject has not completed his or her final vaccination in VAC-010.

For Toddlers NOT Enrolled in VAC-010 (PCV-primed-only cohort):

- Healthy Kenyan toddlers between 12 to 15 (inclusive) months of age who have completed
their primary Expanded Programme on Immunization (EPI) vaccines, with the exception
that the birth dose of oral polio vaccine is not required.

- Subjects who have not received a PCV booster following primary PCV series.

- Subject's parent must provide voluntary written informed consent for subject to
participate in the study, is fully capable of comprehending and complying with study
requirements and procedures, able and willing to return for all scheduled follow-up
visits, and has expressed availability for the required study period, with access to a
consistent means of telephone contact. An illiterate parent will require an impartial
witness to be present during consenting process to include discussing the consent
form, verbal consent and thumb-printing.

- Subjects who were not born premature, had a birth weight of > 2.5 kg, and who have a
weight-to-height Z-score of = -2 at the time of enrollment.

Exclusion Criteria:

- For Toddlers NOT enrolled in VAC-010 (PCV-primed only):

- Use of any investigational or non-registered drug within 90 days prior to screening,
or planned during the course of study participation.

- Immunosuppression or immunodeficiency (inclusive of human immunodeficiency virus
[HIV]) by medical history (inclusive of possible HIV through maternal fetal transfer
at time of birth or through breast milk).

- Chronic, clinically significant pulmonary, cardiovascular, hepatobiliary,
gastrointestinal, renal, neurological, or hematological functional abnormality or
major congenital defects or illness that requires medical therapy, by medical history
or clinical assessment. This includes abnormal vital signs as assessed by toxicity
scoring.

- Any medical or social condition that in the opinion of the investigator may interfere
with the study objectives, pose a risk to the study subject, or prevent the subject
from completing the study.

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

- Disorders that required chronic administration (defined as more than 14 consecutive
days) of immunosuppressants or other immune-modifying drugs within the 6 months prior
to enrollment. An immunosuppressant dose of glucocorticoid will be defined as a
systemic dose >10 mg of prednisone (adult dosage) adjusted for equivalent dosing in
toddlers by weight. The use of topical glucocorticoids will be permitted.

- Administration of immunoglobulins and/or any blood products within the 6 months
preceding enrollment in the study; or anticipation of such administration during the
study period.

- History of meningitis, seizures or any neurological disorder.

- Subject who has evidence of congenital abnormality or developmental delay.

- Any evidence of fetal alcohol syndrome or history of alcohol abuse in mother during
pregnancy.



Age minimum: 12 Months
Age maximum: 15 Months
Gender: All

Health Condition(s) or Problem(s) studied

Pneumococcal Disease

Primary Outcome(s)

Density of Streptococcus Pneumoniae in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Prevalence of Streptococcus Pneumoniae in Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Secondary Outcome(s)

Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2 [Time Frame: Baseline and Week 32]

Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Number of Participants With Neutralizing Antibody Response to Pneumolysin [Time Frame: Baseline (Week 0) and 6 months post-vaccination 2 (Week 32)]

Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group [Time Frame: Week 32]

Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins [Time Frame: Baseline and Week 32]

Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins [Time Frame: Baseline (Week 0), 4 weeks post-vaccination 2 (Week 12), and 6 months post-vaccination 2 (Week 32).]

Number of Adverse Events (AE) [Time Frame: 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.]

Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx [Time Frame: Week 0, Week 12, Week 16, Week 20, Week 32]

Secondary ID(s)

VAC-011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02146365