RECRUITING

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

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.

Conditions

PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE
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Related Conditions:

PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE

Study Overview

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Study Details

Study overview

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.

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

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

Condition
PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE
Intervention / Treatment

-

Contacts and Locations

Rochester

Rochester Clinical Research, Rochester, New York, United States, 14609

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adult aged \> 18 and \< 49 years at screening.
  • * Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2, with a maximum body weight of 120 kg at screening.
  • * Good general health, without significant medical illness or abnormal physical examination, or laboratory findings per PI discretion.
  • * If female, not breastfeeding, not pregnant, and not planning pregnancy during study period.
  • * If female of child-bearing potential, willing to use acceptable method of contraception.
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to 49 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Serum Life Science Europe GmbH,

Study Record Dates

2025-08