Nasopharyngeal Carriage Study in Healthy Kenyan Toddlers

NCT02146365 | Completed Results

• 1 other identifier: VAC-011
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the change in nasopharyngeal carriage (NPC) of Streptococcus pneumoniae (SPn), hypothesizing that it would be reduced post-vaccination with Streptococcus pneumoniae whole cell vaccine with aluminum hydroxide adjuvant (PATH-wSP) and that PATH-wSP would remain safe and well-tolerated over the course of the study.

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (2)

• Prevalence of Streptococcus Pneumoniae in Nasopharynx

  The prevalence of Streptococcus pneumoniae (SPn) in the nasopharynx was measured by the number (and percentage) of participants positive for SPn detected by quantitative polymerase chain reaction (qPCR) from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only plus non-interventional participants enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only plus non-interventional participants enrolled during Cohort 2

  Week 0, Week 12, Week 16, Week 20, Week 32

• Density of Streptococcus Pneumoniae in the Nasopharynx

  The density of Streptococcus pneumoniae (SPn) in the nasopharynx was measured by the number of autolysin (LytA) gene copies detected by quantitative polymerase chain reaction (qPCR) from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: * PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster * Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only plus non-interventional group enrolled during Cohort 1 * PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster * Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

  Week 0, Week 12, Week 16, Week 20, Week 32

Secondary Outcomes (26)

• Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins

  Baseline (Week 0), 4 weeks post-vaccination 2 (Week 12), and 6 months post-vaccination 2 (Week 32).

• Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group

  Week 32

• Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins

  Baseline and Week 32

• Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2

  Baseline and Week 32

• Number of Participants With Neutralizing Antibody Response to Pneumolysin

  Baseline (Week 0) and 6 months post-vaccination 2 (Week 32)

Study Arms (8)

PATH-wSP 300 µg + Booster

Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.

PATH-wSP 300 µg Only

Toddlers who enrolled in Cohort 1 of Study VAC-010 and received 300 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 300 µg PATH-wSP 8 weeks later.

PATH-wSP 600 µg + Booster

Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP plus the two booster vaccines (Synflorix and Pentavac) followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.

PATH-wSP 600 µg Only

Toddlers who enrolled in Cohort 2 of Study VAC-010 and received 600 µg PATH-wSP and 2 saline injections followed by a 2nd injection of 600 µg PATH-wSP 8 weeks later.

Booster Only (300 µg)

Toddlers who enrolled in Cohort 1 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.

Booster Only (600 µg)

Toddlers who enrolled in Cohort 2 of Study VAC-010 and received one saline injection and the two booster vaccines (Synflorix and Pentavac) followed by a 2nd saline injection 8 weeks later.

No Intervention (300 µg)

Toddlers who enrolled during Cohort 1 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).

No Intervention (600 µg)

Toddlers who enrolled during Cohort 2 who did not participate in Study VAC-010 and did not receive either PATH-wSP or either of the booster vaccines (Pentavac or Synflorix).

Eligibility Criteria

• Age: 12 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Healthy PCV- primed Kenyan toddlers; some of whom have participated in VAC-010 (n=250) and some of whom have not (n=50)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• PATH: lead

Study Sites (1)

Kenya Medical Research Institute/Walter Reed Project

Kisumu, 40100, Kenya

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal swab sample and blood draw

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Jorge Flores
• Organization: PATH

jeflores@path.org

(202) 822-0033

Study Officials

• Nekoye Otsyula, MB ChB MSc

  Kenya Medical Research Institute/Walter Reed Project

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 23, 2014
• Study Start: September 25, 2014
• Primary Completion: February 18, 2016
• Study Completion: February 18, 2016
• Last Updated: February 17, 2020
• Results First Posted: February 17, 2020

Record last verified: 2020-01

Locations

KE (1)