Pneumococcal InfectionsPhase 1NCT00479323
Pneumococcal Reference Standard
A Phase 1 study testing Pneumovax 23 in people with Pneumococcal Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Serum 89 SF is a supply of serum that was collected from people who were vaccinated with the pneumococcal vaccine in the late 1980s. The supply of this serum is running low. The purpose of this study is to give the pneumococcal vaccine to healthy volunteers and take serum blood samples in order to increase the… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- Pneumovax 23
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Aug 2008
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or nonpregnant female between the ages of 18 to 45 and weighing a minimum of 110 pounds.
- Women of childbearing potential (not surgically sterile or postmenopausal for >/= 1 year) must agree to practice adequate contraception (ie, barrier method, abstinence, intrauterine device, or licensed hormonal method) for the entire period while on protocol.
- Women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to vaccination and prior to each blood collection.
- Participants must be afebrile and in general good health in the opinion of the investigator as determined by vital signs, medical history, and physical examination.
- Subject laboratory tests, including hemoglobin, hematocrit, total white blood count and platelets, aspartate aminotransferase, alanine aminotransferase, and serum protein. All values must be within normal limits (WNL) except AST and ALT that must less than or equal to 1.5 X ULN and total serum protein >=6.0 gms; Males: hemoglobin >=13.5 gm/dL, hematocrit >=41% Females: hemoglobin >=12.5 gm/dL, hematocrit >=38%
- Serology for hepatitis B (core antibody), C, HIV, rapid plasma reagin, immunoglobulin and HIV must be negative.
- Subjects must have adequate venous access.
- Participants must communicate an understanding of the protocol and provide written informed consent for the protocol.
Who cannot join
- Has received any investigational drug or vaccine within the past 6 months or is currently in any phase of another clinical trial or intends to participate in another clinical trial in the next 6 months.
- Has received any licensed inactivated vaccine within 2 weeks or licensed live vaccine within 4 weeks of screening.
- Has a known allergy to any component of the Pneumovax 23 vaccine.
- Has a history of receiving human blood or any derivative of human blood within the preceding 12 months.
- Has no evidence of skin infection at the potential phlebotomy sites or evidence of systemic or generalized disease that could create a risk of contamination of the serum.
- Has no history of viral hepatitis after the 11th birthday and no history of close contact with an individual diagnosed with viral hepatitis within the past year.
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- Is immunosuppressed as a result of underlying illness or treatment or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
- Long-term use of oral or parenteral steroids or high-dose inhaled steroids within the past 6 months.
- Has a diagnosis of schizophrenia, bipolar disease, major psychiatric diagnosis, or has ever been hospitalized for a psychiatric illness.
- Has a history of alcohol or drug abuse in the past 5 years.
- Has any acute or chronic condition that, in the opinion of the investigator, would render vaccination or blood donation unsafe or the participant unable to meet the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stimulation of Donors for Pneumococcal Reference Serum
Serum 89 SF is a supply of serum that was collected from people who were vaccinated with the pneumococcal vaccine in the late 1980s. The supply of this serum is running low. The purpose of this study is to give the pneumococcal vaccine to healthy volunteers and take serum blood samples in order to increase the reference serum supply. Study participants will include 250 healthy men and women, ages 18-45. Study procedures will include a physical exam, interviews, blood samples and blood testing. All volunteers will receive the pneumococcal vaccine in the deltoid muscle of the arm. Participants will be involved in the study for approximately 17 weeks.
Read the detailed description
Serum 89SF is a pooled sera from individuals vaccinated with a 23 valent pneumococcal polysaccharide vaccine collected in the late 1980s. The 89SF standard for ELISA is running low (2-3 year supply) and is insufficient to serve for opsinophagocytosis assay (OPA), which requires large volumes. The objective of this study is to immunize healthy volunteers with licensed polyvalent pneumococcal polysaccharide vaccine (Pneumovax 23) with subsequent blood donation in a quantity sufficient to make reference sera. Two hundred fifty volunteer subjects will be recruited from a total population of up to 600. Study participants will include healthy men and nonpregnant females, ages 18-45. Subjects will undergo physical examination by a licensed clinician, subject interview, and clinical laboratory and serologic testing. Potential subjects must provide written informed consent and meet all eligibility criteria. On Day 0, subjects will receive 0.5 mL pneumococcal vaccine (Pneumovax 23) in the deltoid muscle. Volunteers will remain in the clinic for 30 minutes following immunization for observation of any adverse reactions. Volunteers will return to clinic in 10-35 days following immunization to donate 1 unit (approximately 500 mL) of blood. Volunteers will return for a second donation of 1 unit of blood not less than 8 weeks and not more than 14 weeks following the first donation.
- Conditions
- Pneumococcal Infections
- Being tested
- Pneumovax 23
- Keywords
- pneumococcal vaccine, Pneumovax, reference sera, serum 89SF
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumovax 23Biological
Licensed pneumococcal vaccine (Pneumovax 23).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Immunize healthy volunteers with pneumococcal vaccine (Pneumovax 23) to obtain a pool of hyperimmune sera in a quantity sufficient to generate reference sera. Receives: Biological: Pneumovax 23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To immunize healthy volunteers with pneumococcal vaccine (Pneumovax 23) to obtain a pool of hyperimmune sera in a quantity sufficient to generate reference sera.
Measured: Duration of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479323
- Sponsor's protocol ID
- 06-0093
- Status last verified
- Apr 2011
- First submitted
- 24 May 2007
- Last updated
- 26 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation of Donors for Pneumococcal Reference Serum
- ClinicalTrials.gov ID
- NCT00479323
- Acronym / sponsor ID
- 06-0093
- Conditions
- Pneumococcal Infections
- Keywords
- pneumococcal vaccine, Pneumovax, reference sera, serum 89SF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jun 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 28 May 2007 (estimated)
- 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.
Serum 89 SF is a supply of serum that was collected from people who were vaccinated with the pneumococcal vaccine in the late 1980s. The supply of this serum is running low. The purpose of this study is to give the pneumococcal vaccine to healthy volunteers and take serum blood samples in order to increase the reference serum supply. Study participants will include 250 healthy men and women, ages 18-45. Study procedures will include a physical exam, interviews, blood samples and blood testing. All volunteers will receive the pneumococcal vaccine in the deltoid muscle of the arm. Participants will be involved in the study for approximately 17 weeks.
Detailed description
Serum 89SF is a pooled sera from individuals vaccinated with a 23 valent pneumococcal polysaccharide vaccine collected in the late 1980s. The 89SF standard for ELISA is running low (2-3 year supply) and is insufficient to serve for opsinophagocytosis assay (OPA), which requires large volumes. The objective of this study is to immunize healthy volunteers with licensed polyvalent pneumococcal polysaccharide vaccine (Pneumovax 23) with subsequent blood donation in a quantity sufficient to make reference sera. Two hundred fifty volunteer subjects will be recruited from a total population of up to 600. Study participants will include healthy men and nonpregnant females, ages 18-45. Subjects will undergo physical examination by a licensed clinician, subject interview, and clinical laboratory and serologic testing. Potential subjects must provide written informed consent and meet all eligibility criteria. On Day 0, subjects will receive 0.5 mL pneumococcal vaccine (Pneumovax 23) in the deltoid muscle. Volunteers will remain in the clinic for 30 minutes following immunization for observation of any adverse reactions. Volunteers will return to clinic in 10-35 days following immunization to donate 1 unit (approximately 500 mL) of blood. Volunteers will return for a second donation of 1 unit of blood not less than 8 weeks and not more than 14 weeks following the first donation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Biological: Pneumovax 23Immunize healthy volunteers with pneumococcal vaccine (Pneumovax 23) to obtain a pool of hyperimmune sera in a quantity sufficient to generate reference sera. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or nonpregnant female between the ages of 18 to 45 and weighing a minimum of 110 pounds.
- Women of childbearing potential (not surgically sterile or postmenopausal for >/= 1 year) must agree to practice adequate contraception (ie, barrier method, abstinence, intrauterine device, or licensed hormonal method) for the entire period while on protocol.
- Women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to vaccination and prior to each blood collection.
- Participants must be afebrile and in general good health in the opinion of the investigator as determined by vital signs, medical history, and physical examination.
- Subject laboratory tests, including hemoglobin, hematocrit, total white blood count and platelets, aspartate aminotransferase, alanine aminotransferase, and serum protein. All values must be within normal limits (WNL) except AST and ALT that must less than or equal to 1.5 X ULN and total serum protein >=6.0 gms; Males: hemoglobin >=13.5 gm/dL, hematocrit >=41% Females: hemoglobin >=12.5 gm/dL, hematocrit >=38%
Key exclusion criteria (11 listed)
- Has received any investigational drug or vaccine within the past 6 months or is currently in any phase of another clinical trial or intends to participate in another clinical trial in the next 6 months.
- Has received any licensed inactivated vaccine within 2 weeks or licensed live vaccine within 4 weeks of screening.
- Has a known allergy to any component of the Pneumovax 23 vaccine.
- Has a history of receiving human blood or any derivative of human blood within the preceding 12 months.
- Has no evidence of skin infection at the potential phlebotomy sites or evidence of systemic or generalized disease that could create a risk of contamination of the serum.
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 |
|---|---|---|
| Pneumovax 23Licensed pneumococcal vaccine (Pneumovax 23). | Biological | 1 |
Primary outcome
To immunize healthy volunteers with pneumococcal vaccine (Pneumovax 23) to obtain a pool of hyperimmune sera in a quantity sufficient to generate reference sera.
Time frame: Duration of study.
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 26 Dec 2016.
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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.
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 Pneumovax 23 in people with Pneumococcal Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 8 inclusion and 11 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 26 Dec 2016. 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. 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?
To immunize healthy volunteers with pneumococcal vaccine (Pneumovax 23) to obtain a pool of hyperimmune sera in a quantity sufficient to generate reference sera. (time frame: Duration of study.). 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 26 Dec 2016.