Pneumococcal VaccinesPhase 1NCT01537185
Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults
A Phase 1 study testing SPWCV+Alum 100 mcg, SPWCV+Alum 600 mcg and SPWCV+Alum 300 mcg in people with Pneumococcal Vaccines, run by PATH Vaccine Solutions at 1 site in United States.
Trial summary
The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine (SPWCV) given with alum is safe and well tolerated by healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Vaccines
- What is being tested?
- SPWCV+Alum 100 mcg, SPWCV+Alum 600 mcg and SPWCV+Alum 300 mcg
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Apr 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- If female, not breastfeeding, not pregnant, not planning pregnancy during study period), and willing to consistently use an adequate method of contraception and have repeated pregnancy tests.
- In good health with normal laboratory results
- Willing to comply with study restrictions, study schedule, and can be reliably contacted
Who cannot join
- Currently consumes alcohol in excess of 2 drinks per day for men or 1 drink per day for women.
- current use or likely requirement for medications with potential for liver injury or effect immune system
- History of event or condition such as anaphylaxis, severe allergic reactions, serious reactions to any vaccines, or other events that might increase risk of reaction to an investigational disease
- History of diabetes, cancer, autoimmune or immunosuppressive disease or chronic such as HIV, Hepatitis B or C
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Clinical Development
Tacoma, Washington, 98418
About this study
Official title: A Phase 1 Randomized, Double-Blind, Dose-Escalation Study to Assess the Safety, Tolerability and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (SPWCV+Alum) in Healthy Adults
The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine (SPWCV) given with alum is safe and well tolerated by healthy adults.
- Conditions
- Pneumococcal Vaccines
- Being tested
- Placebo, SPWCV+Alum 100 mcg, SPWCV+Alum 600 mcg, SPWCV+Alum 300 mcg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
3 cohorts of normal saline injection
SPWCV+Alum 100 mcgBiological
3 injections 28 days apart
SPWCV+Alum 600 mcgBiological
3 injections 28 days apart
SPWCV+Alum 300 mcgBiological
3 injections 28 days apart
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 SPWCV+Alum 100 mcg | Experimental | each individual receiving 3 vaccinations of same dose 28 days apart Receives: Biological: SPWCV+Alum 100 mcg |
| Cohort 2 SPWCV+Alum 300 mcg | Experimental | each individual receiving 3 vaccinations of same dose 28 days apart Receives: Biological: SPWCV+Alum 300 mcg |
| Cohort 3 SPWCV+Alum 600 mcg | Experimental | each individual receiving 3 vaccinations of same dose 28 days apart Receives: Biological: SPWCV+Alum 600 mcg |
| Normal Saline Injection | Placebo comparator | placebo group within each cohort receive 3 injections of normal saline 28 days apart
normal saline injection: 3 cohorts of normal saline injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unsolicited Adverse Event Reports
Safety and Tolerability assessed by cohort and product received measured by:
•Number of unsolicited AEs within four weeks after each vaccination
Measured: within 1 week (0-7 days) following each vaccinations
Secondary outcomes (1)
Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG
- Determination of a humoral immune response to whole cell antigen as determined by ELISA of sera collected on Day 0, 28, 56, and 84.
Measured: 28, 56 and 84 days following initial vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal VaccinesStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH Vaccine Solutions
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Royce Morrison, M.D., Principal investigator, Comprehensive Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537185
- Sponsor's protocol ID
- VAC 002
- Status last verified
- Feb 2012
- First submitted
- 7 Feb 2012
- Last updated
- 5 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Keech CA, Morrison R, Anderson P, Tate A, Flores J, Goldblatt D, Briles D, Hural J, Malley R, Alderson MR. A Phase 1 Randomized, Placebo-controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of Inactivated Streptococcus pneumoniae Whole-cell Vaccine in Adults. Pediatr Infect Dis J. 2020 Apr;39(4):345-351. doi: 10.1097/INF.0000000000002567.
PubMed 31895881Campo JJ, Le TQ, Pablo JV, Hung C, Teng AA, Tettelin H, Tate A, Hanage WP, Alderson MR, Liang X, Malley R, Lipsitch M, Croucher NJ. Panproteome-wide analysis of antibody responses to whole cell pneumococcal vaccination. Elife. 2018 Dec 28;7:e37015. doi: 10.7554/eLife.37015.
PubMed 30592459
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Dose-Escalation Study to Assess the Safety, Tolerability and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (SPWCV+Alum) in Healthy Adults
- ClinicalTrials.gov ID
- NCT01537185
- Acronym / sponsor ID
- VAC 002
- Conditions
- Pneumococcal Vaccines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- PATH Vaccine SolutionsUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 23 Feb 2012 (estimated)
- Results
- Posted 5 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine (SPWCV) given with alum is safe and well tolerated by healthy adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 SPWCV+Alum 100 mcg | Experimental | Biological: SPWCV+Alum 100 mcgeach individual receiving 3 vaccinations of same dose 28 days apart |
| Cohort 2 SPWCV+Alum 300 mcg | Experimental | Biological: SPWCV+Alum 300 mcgeach individual receiving 3 vaccinations of same dose 28 days apart |
| Cohort 3 SPWCV+Alum 600 mcg | Experimental | Biological: SPWCV+Alum 600 mcgeach individual receiving 3 vaccinations of same dose 28 days apart |
| Normal Saline Injection | Placebo comparator | Other: Placeboplacebo group within each cohort receive 3 injections of normal saline 28 days apart normal saline injection: 3 cohorts of normal saline injection |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- If female, not breastfeeding, not pregnant, not planning pregnancy during study period), and willing to consistently use an adequate method of contraception and have repeated pregnancy tests.
- In good health with normal laboratory results
- Willing to comply with study restrictions, study schedule, and can be reliably contacted
Key exclusion criteria (4 listed)
- Currently consumes alcohol in excess of 2 drinks per day for men or 1 drink per day for women.
- current use or likely requirement for medications with potential for liver injury or effect immune system
- History of event or condition such as anaphylaxis, severe allergic reactions, serious reactions to any vaccines, or other events that might increase risk of reaction to an investigational disease
- History of diabetes, cancer, autoimmune or immunosuppressive disease or chronic such as HIV, Hepatitis B or C
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 |
|---|---|---|
| Placebo3 cohorts of normal saline injection | Other | Normal Saline Injection |
| SPWCV+Alum 100 mcg3 injections 28 days apart | Biological | Cohort 1 SPWCV+Alum 100 mcg |
| SPWCV+Alum 600 mcg3 injections 28 days apart | Biological | Cohort 3 SPWCV+Alum 600 mcg |
| SPWCV+Alum 300 mcg3 injections 28 days apart | Biological | Cohort 2 SPWCV+Alum 300 mcg |
Primary outcome
Unsolicited Adverse Event Reports
Time frame: within 1 week (0-7 days) following each vaccinations
Safety and Tolerability assessed by cohort and product received measured by: •Number of unsolicited AEs within four weeks after each vaccination
1 secondary outcome
Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG
Time frame: 28, 56 and 84 days following initial vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31895881Keech CA, Morrison R, Anderson P, Tate A, Flores J, Goldblatt D, Briles D, Hural J, Malley R, Alderson MR. A Phase 1 Randomized, Placebo-controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of Inactivated Streptococcus pneumoniae Whole-cell Vaccine in Adults. Pediatr Infect Dis J. 2020 Apr;39(4):345-351. doi: 10.1097/INF.0000000000002567.
- Derived from this study: PubMed 30592459Campo JJ, Le TQ, Pablo JV, Hung C, Teng AA, Tettelin H, Tate A, Hanage WP, Alderson MR, Liang X, Malley R, Lipsitch M, Croucher NJ. Panproteome-wide analysis of antibody responses to whole cell pneumococcal vaccination. Elife. 2018 Dec 28;7:e37015. doi: 10.7554/eLife.37015.
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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.
Royce Morrison, M.D. principal investigator
Comprehensive Clinical Development
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 SPWCV+Alum 100 mcg, SPWCV+Alum 600 mcg and SPWCV+Alum 300 mcg in people with Pneumococcal Vaccines, run by PATH Vaccine Solutions 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 3 inclusion and 4 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 5 Jun 2014. 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?
Yes. Results are posted in the registry (first posted 5 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Unsolicited Adverse Event Reports (time frame: within 1 week (0-7 days) following each vaccinations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01537185, which also lists 2 linked publications.
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 5 Jun 2014.