New pneumonia vaccine passes first safety check in small human trial
NCT ID NCT07059182
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested whether a new whole-cell pneumonia vaccine is safe for people. Thirty healthy adults received either the vaccine or a placebo and were monitored for 30 days. The main goal was to check for side effects like pain, fever, or headache. This study does not yet measure if the vaccine prevents pneumonia.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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30 people
The number who actually took part.
- Started
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Jun 2025
- Finished
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Aug 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 49 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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. Exclusion Criteria: In addition to meeting the inclusion criteria, individuals will be excluded from this trial if they meet any of the following exclusion criteria: * History or presence of clinically significant medical condition or disease, including (but not limited to) clinically significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, hematologic, immunologic, oncologic, rheumatologic, dermatologic, neurological or psychiatric disease. * History of known invasive pneumococcal disease. * History of congenital or acquired immunodeficiency. * Any acute illness within 72 hours prior to randomization. * Abnormal vital sign(s) or laboratory test result(s) deemed clinically relevant, as determined by the PI. * Known allergy or previous anaphylaxis to any components of the study product or contraindication to intramuscular (IM) injection (e.g., history of bleeding disorder). * Previous enrollment in this trial or received other investigational vaccines, drugs, or products within the past 12 weeks, or intend to participate in another clinical trial during the duration of this trial. * Received any vaccine within the past 4 weeks. * Received any immunomodulating or immunosuppressive agent or medicine, including over-the-counter, herbal and prescription drugs and supplements within the past 12 weeks or anticipate needing within the study period. * Received blood or blood products within the past 12 weeks or anticipate needing within the study period. * Current use of over the counter or prescription drugs of known hepatotoxicity. * Current or history of alcohol or drug dependence or abuse. * Any condition (medical, psychiatric, or behavioral) that in the opinion of the PI, would increase the participant's health risks in study participation or would increase the risk of not achieving the study's objectives. * Unable or unwilling to provide adequate informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Rochester Clinical Research
Rochester, New York, 14609, United States