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Pneumococcal DiseaseNCT02146365

Nasopharyngeal Carriage Study in Healthy Kenyan Toddlers

An observational study of Pneumococcal Disease, run by PATH at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 15 monthsHealthy volunteers can take part
Conditions the study is for
Pneumococcal Disease
How many people
297 participants
Where
1 siteKenya
Study dates
25 Sep 2014to 18 Feb 2016
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 15 months
  • All sexes
  • Healthy volunteers accepted
  • Child

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)

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • Kenya Medical Research Institute/Walter Reed Project

    Kisumu, 40100

Other trials in Kenya

About this study

Official 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

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.

Read the detailed description

This study enrolled healthy Kenyan toddlers (12-15 months of age) who participated in the randomized control trial of VAC-010 (NCT02097472), as well as healthy toddlers aged 12 to 15 months who had not participated in the VAC-010 Study. All participants must have received a primary dose of pneumococcal conjugate vaccine (PCV) per local practice prior to enrollment in either VAC-010 or VAC-011. No treatments were administered during this study.

The study consisted of the following four groups:

Participants who were randomized in study VAC-010 (2:2:1 ratio), defined according to the treatment received in VAC-010:

  • 1. PATH-wSP + Booster
  • 2. PATH-wSP Only
  • 3. Booster Only

Participants who did not participate in VAC-010:

  • 4. No Intervention

Each group consisted of 2 cohorts of participants, Cohort 1 (300 µg PATH-wSP) and Cohort 2 (600 µg PATH-wSP). Enrollment into Cohorts 1 and 2 occurred sequentially; participants in groups 3 and 4 who did not receive PATH-wSP were also enrolled over time and allocated into one of the two cohorts (300 and 600 µg) in order to control for potential seasonal variation in the NPC of S. pneumoniae.

Each participant completed a total of 5 scheduled visits. For toddlers enrolled simultaneously in VAC-010, visits corresponded to enrollment (Baseline) and 4, 8, 12, and 24 weeks post final vaccination in VAC-010. For toddlers in the No Intervention group, the first visit corresponded to Baseline and the second to fifth visits corresponded to 12, 16, 20, and 32 weeks later. Nasopharyngeal swabs were taken at each visit following World Health Organization (WHO) guidelines for analysis of nasopharyngeal burden.

Treatments received during VAC-010 included:

  • PATH-wSP: Streptococcus pneumoniae whole cell vaccine with aluminum hydroxide adjuvant
  • Synflorix™ booster vaccine: pneumococcal polysaccharide conjugate vaccine (adsorbed)
  • Pentavac booster vaccine: diphtheria, tetanus, pertussis (Whole Cell), hepatitis B (recombinant deoxyribonucleic acid [rDNA]) and Haemophilus influenzae type b conjugate vaccine (adsorbed).
  • Saline control
Medical subject headings
Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02146365
Study groupRoleWhat they receive
PATH-wSP 300 µg + BoosterToddlers 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 OnlyToddlers 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 + BoosterToddlers 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 OnlyToddlers 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  2. 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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

Secondary outcomes (26)

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

    Immunogenicity was evaluated based on the following assays:

    1. Immunoglobulin (IgG) response to pneumolysoid [L460D] and pneumococcal surface protein A family 1 [PspA-Fam1] was measured by enzyme-linked immunosorbent assay (ELISA).
    2. IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform:
    • L460D
    • PspA-Fam1
    • Pneumococcal histidine triad D (PhtD)
    • Boston Children's Hospital protein 785 (BCH0785)
    • Serine threonine kinase protein (StkP)
    • Pneumococcal choline-binding protein A (PcpA)
    • Streptococcus pneumonia whole cell antigen (SPWCA)
    • Pneumococcal iron uptake protein A (PiuA)
    • Pneumococcal iron acquisition protein A (PiaA)

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

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

    Data reported are the geometric mean concentration at 6 months post-vaccination 2 (Week 32) for each PATH-wSP group divided by the Booster (Synflorix and Pentavax)-only group (N=38). Immunogenicity was evaluated based on the following assays:

    1. Immunoglobulin (IgG) response to pneumolysoid (L460D) and pneumococcal surface protein A family 1 (PspA-Fam1) was measured by enzyme-linked immunosorbent assay (ELISA).
    2. IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform:
    • L460D
    • PspA-Fam1
    • Pneumococcal histidine triad D (PhtD)
    • Boston Children's Hospital protein 785 (BCH0785)
    • Serine threonine kinase protein (StkP)
    • Pneumococcal choline-binding protein A (PcpA)
    • Streptococcus pneumonia whole cell antigen (SPWCA)
    • Pneumococcal iron uptake protein A (PiuA)
    • Pneumococcal iron acquisition protein A (PiaA)

    Measured: Week 32

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

    Immunogenicity was evaluated based on the following assays:

    1. IgG response to pneumolysoid [L460D] and pneumococcal surface protein A family 1 [PspA-Fam1] was measured by enzyme-linked immunosorbent assay (ELISA).
    2. IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform:
    • L460D
    • PspA-Fam1
    • Pneumococcal histidine triad D (PhtD)
    • Boston Children's Hospital protein 785 (BCH0785)
    • Serine threonine kinase protein (StkP)
    • Pneumococcal choline-binding protein A (PcpA)
    • Streptococcus pneumonia whole cell antigen (SPWCA)
    • Pneumococcal iron uptake protein A (PiuA)
    • Pneumococcal iron acquisition protein A (PiaA)

    The fold-change was calculated as the 6-month post-vaccination (Week 32) IgG response divided by the Baseline IgG response.

    Measured: Baseline and Week 32

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

    The percentage of participants with a seroresponse, defined as a ≥ 2, ≥ 3, and ≥ 4 fold-rise above Baseline in IgG antibody levels against Pneumococcal proteins. Fold-rise was calculated as the 6-month post-vaccination (Week 32) IgG response divided by the Baseline IgG level.

    Immunogenicity was evaluated based on the following assays:

    1. IgG response to pneumolysoid [L460D] and pneumococcal surface protein A family 1 [PspA-Fam1] was measured by enzyme-linked immunosorbent assay (ELISA).
    2. IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform:
    • L460D
    • PspA-Fam1
    • Pneumococcal histidine triad D (PhtD)
    • Boston Children's Hospital protein 785 (BCH0785)
    • Serine threonine kinase protein (StkP)
    • Pneumococcal choline-binding protein A (PcpA)
    • Streptococcus pneumonia whole cell antigen (SPWCA)
    • Pneumococcal iron uptake protein A (PiuA)
    • Pneumococcal iron acquisition protein A (PiaA)

    Measured: Baseline and Week 32

  5. Number of Participants With Neutralizing Antibody Response to Pneumolysin

    Neutralizing antibody responses to pneumolysin were assessed at Baseline and 6 months post vaccination 2 using an in vitro toxin neutralization assay that measures the ability of antibodies to neutralize wild-type pneumolysin-induced lysis of rabbit red blood cells.

    Each sample was categorized as negative (< 1/20 dilution) or positive (with titer between 1/20 and 1/320 dilution). Responses at higher dilutions indicate higher levels of neutralizing antibodies to pneumolysin.

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

  6. Number of Adverse Events (AE)

    An AE was defined as any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or psychological/physiologic observations occurring in a person in a clinical study. The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.

    Measured: 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.

  7. Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx

    Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 11A/D/E [11A] is reported.

    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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  8. Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx

    Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 13 is reported.

    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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  9. Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx

    Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 15A is reported.

    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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  10. Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx

    Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 15B/C [15B] is reported.

    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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  11. Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx

    Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 19A is reported.

    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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  12. Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx

    Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 19F is reported.

    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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  13. Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx

    Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 3 is reported.

    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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  14. Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx

    Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 35B is reported.

    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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  15. Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx

    Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 6A/B [6A] is reported.

    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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  16. Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx

    Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype NT4b is reported.

    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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  17. Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx

    The density of Streptococcus pneumoniae serotype 11A/D/E [11A] in the nasopharynx was measured by the number of LytA gene copies detected by microarray 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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  18. Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx

    The density of Streptococcus pneumoniae serotype 13 in the nasopharynx was measured by the number of LytA gene copies detected by microarray 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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  19. Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx

    The density of Streptococcus pneumoniae serotype 15A in the nasopharynx was measured by the number of LytA gene copies detected by microarray 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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  20. Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx

    The density of Streptococcus pneumoniae serotype 15B/C [15B] in the nasopharynx was measured by the number of LytA gene copies detected by microarray 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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  21. Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx

    The density of Streptococcus pneumoniae serotype 19A in the nasopharynx was measured by the number of LytA gene copies detected by microarray 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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  22. Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx

    The density of Streptococcus pneumoniae serotype 19F in the nasopharynx was measured by the number of LytA gene copies detected by microarray 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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  23. Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx

    The density of Streptococcus pneumoniae serotype 3 in the nasopharynx was measured by the number of LytA gene copies detected by microarray 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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  24. Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx

    The density of Streptococcus pneumoniae serotype 35B in the nasopharynx was measured by the number of LytA gene copies detected by microarray 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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  25. Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx

    The density of Streptococcus pneumoniae serotype 6A/B [6A] in the nasopharynx was measured by the number of LytA gene copies detected by microarray 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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

  26. Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx

    The density of Streptococcus pneumoniae serotype NT4b in the nasopharynx was measured by the number of LytA gene copies detected by microarray 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

    Measured: Week 0, Week 12, Week 16, Week 20, Week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2014 (estimated)
  2. Study start25 Sep 2014
  3. Primary completion18 Feb 2016
  4. Study completion18 Feb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02146365
Sponsor's protocol ID
VAC-011
Status last verified
Jan 2020
First submitted
21 May 2014
Last updated
17 Feb 2020
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumococcal Disease, run by PATH at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of Streptococcus Pneumoniae in Nasopharynx (time frame: Week 0, Week 12, Week 16, Week 20, Week 32). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02146365.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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