deltatrials
Completed NA INTERVENTIONAL 4-arm NCT01307449

Systems Biology of PNEUMOVAX®23 and PREVNAR 13®

Systems Biology of 23 Valent Pneumococcal Polysaccharide Vaccine (PNEUMOVAX®23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR 13®)

Sponsor: Emory University

Updated 7 times since 2017 Last updated: Sep 28, 2018 Started: Apr 30, 2014 Primary completion: Jul 31, 2017 Completion: Jul 31, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A NA clinical study on Pneumococcal Infection, this trial is completed. The trial is conducted by Emory University and has accumulated 7 data snapshots since 2014. Infectious disease trials contribute critical data for public health response and treatment development.

Study Description(click to expand)

RATIONALE: PCV13 \[13-valent pneumococcal conjugate vaccine (Prevnar®13)\] induces better functional immune responses when compared to PPV23 \[23-valent pneumococcal polysaccharide vaccine (Pneumovax®23)\] in older naïve adults. We hypothesize that this is due to intrinsic defects in innate responses that could explain the poor immunogenicity of PPV23 when compared to PCV13. Therefore, we propose to extensively study innate and adaptive immune responses generated after administration of either pneumococcal polysaccharide or conjugate vaccines in older adults. STUDY DESIGN: Single center, open label study in which adult healthy volunteers will be vaccinated with either PPV23 or PCV13. Blood samples will be collected on Days D0 (at enrollment) and D1, D3, D7, D14, D30 and D180 post vaccination to study innate and adaptive immune responses. Even though PPV23 and PCV13 are considered safe, volunteers will be asked to report any local or systemic AEs from Day 0 (vaccination) to Day 7 . Reactogenicity events will also be evaluated by injection site examination on visits at D0, D1, D3 and D7. Also volunteers are asked to report any local or systemic AEs for 30 days post vaccination and any SAEs for 180 days post vaccination. Volunteers are also asked to report local and systemic AEs developing...

RATIONALE: PCV13 \[13-valent pneumococcal conjugate vaccine (Prevnar®13)\] induces better functional immune responses when compared to PPV23 \[23-valent pneumococcal polysaccharide vaccine (Pneumovax®23)\] in older naïve adults. We hypothesize that this is due to intrinsic defects in innate responses that could explain the poor immunogenicity of PPV23 when compared to PCV13. Therefore, we propose to extensively study innate and adaptive immune responses generated after administration of either pneumococcal polysaccharide or conjugate vaccines in older adults.

STUDY DESIGN: Single center, open label study in which adult healthy volunteers will be vaccinated with either PPV23 or PCV13. Blood samples will be collected on Days D0 (at enrollment) and D1, D3, D7, D14, D30 and D180 post vaccination to study innate and adaptive immune responses.

Even though PPV23 and PCV13 are considered safe, volunteers will be asked to report any local or systemic AEs from Day 0 (vaccination) to Day 7 . Reactogenicity events will also be evaluated by injection site examination on visits at D0, D1, D3 and D7. Also volunteers are asked to report any local or systemic AEs for 30 days post vaccination and any SAEs for 180 days post vaccination. Volunteers are also asked to report local and systemic AEs developing the day of a blood draw.

Status Flow

~Jan 2017 – ~Dec 2017 · 11 months · monthly snapshotActive Not Recruiting~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshotCompleted~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshotCompleted~Nov 2018 – ~Jan 2021 · 26 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed NA

  2. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  3. Jan 2021 — Jul 2024 [monthly]

    Completed NA

  4. Nov 2018 — Jan 2021 [monthly]

    Completed NA

  5. Jun 2018 — Nov 2018 [monthly]

    Completed NA

Show 2 earlier versions
  1. Dec 2017 — Jun 2018 [monthly]

    Completed NA

    Status: Active Not RecruitingCompleted

  2. Jan 2017 — Dec 2017 [monthly]

    Active Not Recruiting NA

    First recorded

Apr 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Emory University
  • National Institute of Allergy and Infectious Diseases (NIAID)
Data source: Emory University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations