PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASEPhase 1STREPTO VAC INCT07059182
Safety Study of a Single Dose of Pneumococcal Whole-Cell Vaccine in Healthy Adults
A Phase 1 study testing Inactivated whole-cell Streptococcus pneumoniae vaccine in people with PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE and Prevention of Pneumococcal-induced Acute Otitis Media, run by Serum Life Science Europe GmbH at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE, Prevention of Pneumococcal-induced Acute Otitis Media
- What is being tested?
- Inactivated whole-cell Streptococcus pneumoniae vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2025to 29 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rochester Clinical Research
Rochester, New York, 14609
About this study
Official title: Phase 1 Trial to Assess Safety and Tolerability of a Single Dose of Streptococcus Pneumoniae Whole-Cell (wSp) Vaccine in Healthy Adults
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, Prevention of Pneumococcal-induced Acute Otitis Media
- Being tested
- Inactivated whole-cell Streptococcus pneumoniae vaccine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated whole-cell Streptococcus pneumoniae vaccineBiological
Also called Streptococcus pneumoniae Whole Cell Vaccine (SPWCV), wSp vaccine
Single intramuscular injection of 1 mg protein/0.5 mL wSp vaccine
PlaceboDrug
Also called Saline
Single intramuscular injection of 0.5 mL placebo
| Study group | Role | What they receive |
|---|---|---|
| 1x 1 mg wSp vaccine | Experimental | The study product, wSp vaccine, will be supplied as single-dose glass vials in normal saline (0.9% sodium chloride) at 1 mg protein/0.5 mL, with aluminium hydroxide at 1.2 mg elemental Al/mL. 0.5 mL of study product will be administered in the participant's deltoid as an intramuscular injection. Receives: Biological: Inactivated whole-cell Streptococcus pneumoniae vaccine |
| Placebo | Placebo comparator | Placebo will consist of normal saline (0.9% sodium chloride). 0.5 mL of placebo will be administered in the participant's deltoid as an intramuscular injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability outcome
Occurrence and severity of local reactogenicity (injection site pain, tenderness, redness, swelling, itching, local lymphadenopathy) and systemic reactogenicity (headache, muscle pain, fever, nausea, vomiting, excessive fatigue, and diarrhea) within 7 days post-vaccination.
Occurrence, severity, and relatedness of solicited AEs and SAEs through Day 30.
Occurrence, severity, and relatedness of unsolicited AEs and SAEs through Day 30.
Measured: within 7 days post-vaccination//through Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start11 Jun 2025
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serum Life Science Europe GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059182
- Sponsor's protocol ID
- wSp-US-1.05AOM
- Acronym
- STREPTO VAC I
- Status last verified
- Oct 2025
- First submitted
- 1 Jul 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial to Assess Safety and Tolerability of a Single Dose of Streptococcus Pneumoniae Whole-Cell (wSp) Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT07059182
- Acronym / sponsor ID
- STREPTO VAC I / wSp-US-1.05AOM
- Conditions
- PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE, Prevention of Pneumococcal-induced Acute Otitis Media
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Serum Life Science Europe GmbHIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1x 1 mg wSp vaccine | Experimental | Biological: Inactivated whole-cell Streptococcus pneumoniae vaccineThe study product, wSp vaccine, will be supplied as single-dose glass vials in normal saline (0.9% sodium chloride) at 1 mg protein/0.5 mL, with aluminium hydroxide at 1.2 mg elemental Al/mL. 0.5 mL of study product will be administered in the participant's deltoid as an intramuscular injection. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will consist of normal saline (0.9% sodium chloride). 0.5 mL of placebo will be administered in the participant's deltoid as an intramuscular injection. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inactivated whole-cell Streptococcus pneumoniae vaccineAlso: Streptococcus pneumoniae Whole Cell Vaccine (SPWCV), wSp vaccineSingle intramuscular injection of 1 mg protein/0.5 mL wSp vaccine | Biological | 1x 1 mg wSp vaccine |
| PlaceboAlso: SalineSingle intramuscular injection of 0.5 mL placebo | Drug | Placebo |
Primary outcome
Safety and tolerability outcome
Time frame: within 7 days post-vaccination//through Day 30
Occurrence and severity of local reactogenicity (injection site pain, tenderness, redness, swelling, itching, local lymphadenopathy) and systemic reactogenicity (headache, muscle pain, fever, nausea, vomiting, excessive fatigue, and diarrhea) within 7 days post-vaccination. Occurrence, severity, and relatedness of solicited AEs and SAEs through Day 30. Occurrence, severity, and relatedness of unsolicited AEs and SAEs through Day 30.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inactivated whole-cell Streptococcus pneumoniae vaccine in people with PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE and Prevention of Pneumococcal-induced Acute Otitis Media, run by Serum Life Science Europe GmbH at 1 site in United States.
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 7 inclusion and 15 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 3 Nov 2026. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability outcome (time frame: within 7 days post-vaccination//through Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.