COMPLETED

Safety Study of a Single Dose of Pneumococcal Whole-Cell Vaccine in Healthy Adults

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if whole-cell Streptococcus pneumoniae (wSp) vaccination is safe and tolerated in healthy adults. The main aim is to evaluate the safety and tolerability of wSp vaccine. Researchers will compare wSp vaccinated participants with placebo-treated participants. Participants will be administered once with 1mg wSp vaccine or placebo. After dosing, they will be followed up for 30 days. In addition to the screening and enrollment visits, each participant will come to the study site for scheduled study visits on Days 14 and 30 to undergo study evaluations and measurements and to monitor safety. Each participant also will receive scheduled phone calls on Days 3 and 7 to monitor safety.

Official Title

Phase 1 Trial to Assess Safety and Tolerability of a Single Dose of Streptococcus Pneumoniae Whole-Cell (wSp) Vaccine in Healthy Adults

Quick Facts

Study Start:2025-06-11
Study Completion:2025-08-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT07059182

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 49 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult aged \> 18 and \< 49 years at screening.
  2. * Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2, with a maximum body weight of 120 kg at screening.
  3. * Good general health, without significant medical illness or abnormal physical examination, or laboratory findings per PI discretion.
  4. * If female, not breastfeeding, not pregnant, and not planning pregnancy during study period.
  5. * If female of child-bearing potential, willing to use acceptable method of contraception.
  6. * Willing and able to comply with all study activities, assessments, and restrictions through 30 days of follow-up. Willing and able to be contacted reliably by phone, and willing for the study team to record phone voice messages as needed.
  7. * Provided written informed consent to participate in the clinical trial before any study-related activities are carried out and, in the PI's opinion, must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Rochester Clinical Research
Rochester, New York, 14609
United States

Collaborators and Investigators

Sponsor: Serum Life Science Europe GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-11
Study Completion Date2025-08-29

Study Record Updates

Study Start Date2025-06-11
Study Completion Date2025-08-29

Terms related to this study

Additional Relevant MeSH Terms

  • PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE
  • Prevention of Pneumococcal-induced Acute Otitis Media