Pneumococcal InfectionPhase 2NCT00133549
9-valent CRM 197 Pneumococcal
A Phase 2 study testing PNU-IMUNE®23 and Nine-valent pneumococcal conjugate (PNCRM9) in people with Pneumococcal Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and immune response of a conjugated pneumococcal vaccine compared to a licensed 23-valent polysaccharide pneumococcal vaccine in elderly adults. Study participants will include 180 adults, 65 years of age or greater. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infection
- What is being tested?
- PNU-IMUNE®23 and Nine-valent pneumococcal conjugate (PNCRM9)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2000to Dec 2002
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Persons age 65 years and older.
- Able to give informed consent. Informed consent will be assessed with a brief questionnaire.
- Subjects must be physically able to monitor and record side effects, including reading a digital thermometer and measuring erythema and induration, with assistance from others as needed.
- Subjects must be available for follow-up over the next 9 months
Who cannot join
- Known previous receipt of licensed pneumococcal PS vaccination within the previous 5 years. Prior vaccination history will be obtained from current and previous health care providers, if available.
- Previous vaccination with any pneumococcal glycoconjugate vaccine.
- High risk medical condition for pneumococcus such as splenectomy, nephrotic syndrome, or lymphoma.
- Immunosuppressive diseases or immunosuppressive therapy. This includes doses of steroids greater than 10 mg daily (or its equivalent), cancer chemotherapy, or known HIV disease.
- History of idiopathic thrombocytopenic purpura.
- Acute respiratory illness or fever (temperature >38 degrees C or 100.4 degrees F) within one week of vaccination. Subjects can be reconsidered for enrollment when they recover from their illness.
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- History of allergy to any of the vaccine components or previous severe allergic reaction to any vaccination.
- Any medical condition that would in the opinion of the investigator, interfere with the evaluation of the study objectives.
- Documented S. pneumoniae infection in the past 5 years.
- Screening laboratory values outside the following limits: 1) hematocrit below 28%, 2) WBC <3,000 or over 13,500 per ul, 3) platelets below 125,000 or above 500,000 per ul, 4) creatinine above 2.8 mg/dl or BUN above 75 mg/dl, and 5) AST/SGOT or ALT/SGPT over 110 U/L, Alkaline phosphatase over 200 IU/I or a bilirubin over 2.8 mg/dl.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
University of Rochester
Rochester, New York, 14642
About this study
Official title: Evaluation of a 9-valent CRM 197- Conjugated Pneumococcal Polysaccharide Vaccine in Elderly Adults
The purpose of this study is to evaluate the safety and immune response of a conjugated pneumococcal vaccine compared to a licensed 23-valent polysaccharide pneumococcal vaccine in elderly adults. Study participants will include 180 adults, 65 years of age or greater. Participants will be randomly assigned to 1 of 3 possible groups. Subjects will maintain a study diary to record side effects and oral temperatures for 7 days following each vaccination. Blood samples will be collected before and 1 month following each dose of vaccine or placebo. Participants will be involved in study related procedures for up to 268 days.
Read the detailed description
Elderly individuals are at an increased risk for serious pneumococcal infection. The efficacy of the licensed pneumococcal vaccine is also lower in this at risk population. The precise immunologic reason for the increased susceptibility and decreased efficacy with advancing age is unknown. Understanding and improving the response to pneumococcal vaccine in persons over the age of 65 is an important step in preventing this serious illness. The proposed study will evaluate the relative safety and immunogenicity of 9-valent CRM 197 protein-conjugated pneumococcal polysaccharide (CRM-PS) compared to the currently licensed 23-polysaccharide (PS) vaccines in elderly adults. In addition, the response to revaccination following conjugate vaccine will also be evaluated. Outcome measurements will include adverse effects, standard ELISA measurements of serotype specific antibody, as well as antibody response to carrier protein, effects on functional antibody status and on nasal carriage of S. pneumoniae. The study will be conducted in 180 adults who are 65 years of age and older and who have not received pneumococcal vaccine within the last 5 years. Patients will be assigned to 1 of 3 groups at random in a double blind manner. One dose of vaccine and 1 dose of placebo or 2 doses of 9-valent CRM-PS vaccine will be administered at an interval of 4 months and compared to a single dose of PS vaccine and 1 dose of placebo. Subjects will be evaluated for local and system side effects using a 7-day diary card and clinical and telephone follow-up. Serologic evaluation will be done before and 1 month following each vaccination or placebo. Subjects who received CRM-PS will receive a dose of PS vaccine 8 months after the first dose of vaccine, and potential priming by previous conjugate vaccine will be assessed by measuring the quality and quantity of the antibody response to revaccination. Participants will be involved in study related procedures for up to 268 days.
- Conditions
- Pneumococcal Infection
- Being tested
- Placebo, PNU-IMUNE®23, Nine-valent pneumococcal conjugate (PNCRM9)
- Keywords
- pneumococcal vaccine, 23-valent polysaccharide vaccine, elderly
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Saline placebo administered in a volume of 0.5 ml intramuscularly.
PNU-IMUNE®23Biological
The 23-valent pneumococcal vaccine (PS) vaccine will contain a mixture of 25 micrograms purified, pneumococcal polysaccharide of each of 23 serotypes of Streptococcus pneumoniae per 0.5 ml dose in isotonic saline and 0.01% thimerosal. The vaccine will be administered in a volume of 0.5 ml intramuscularly.
Nine-valent pneumococcal conjugate (PNCRM9)Biological
Cross-reactive material 197 (CRM 197) is a product of the Corynebacterium diphtheria C7. Vaccine is prepared from pneumococcal polysaccharides of types 1, 4, 5, 9V, 14, 18C, 19F, 23F (2 mcg each) and 6B (4 mcg) covalently linked to CRM197 by reductive amination. The protein-polysaccharide combination is prepared as a lyophilized powder with aluminum phosphage which is reconsitituted before use. The vaccine will be administered in a volume of 0.5 ml intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Vaccine dose 1: CRM-PS; Vaccine dose 2 (month 4): CRM-PS; Vaccine dose 3 (month 8): PS. Receives: Biological: PNU-IMUNE®23; Biological: Nine-valent pneumococcal conjugate (PNCRM9) |
| 1 | Experimental | Vaccine dose 1: CRM-PS; Vaccine dose 2 (month 4): saline placebo; Vaccine dose 3 (month 8): PS. Receives: Drug: Placebo; Biological: PNU-IMUNE®23; Biological: Nine-valent pneumococcal conjugate (PNCRM9) |
| 3 | Active comparator | Vaccine dose 1: PS; Vaccine dose 2 (month 4): saline placebo; Vaccine dose 3 (month 8): saline placebo. Receives: Drug: Placebo; Biological: PNU-IMUNE®23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effects.
Measured: Duration of study.
Antibody response to carrier protein, effects on functional antibody status and on nasal carriage of S. pneumoniae.
Measured: Before and 1 month following each vaccine or placebo.
Standard ELISA measurements of serotype specific antibody.
Measured: Before and 1 month following each vaccine or placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startNov 2000
- Primary completionDec 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133549
- Sponsor's protocol ID
- 99-023
- Status last verified
- May 2011
- First submitted
- 19 Aug 2005
- Last updated
- 17 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a 9-valent CRM 197- Conjugated Pneumococcal Polysaccharide Vaccine in Elderly Adults
- ClinicalTrials.gov ID
- NCT00133549
- Acronym / sponsor ID
- 99-023
- Conditions
- Pneumococcal Infection
- Keywords
- pneumococcal vaccine, 23-valent polysaccharide vaccine, elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 2000
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 23 Aug 2005 (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.
The purpose of this study is to evaluate the safety and immune response of a conjugated pneumococcal vaccine compared to a licensed 23-valent polysaccharide pneumococcal vaccine in elderly adults. Study participants will include 180 adults, 65 years of age or greater. Participants will be randomly assigned to 1 of 3 possible groups. Subjects will maintain a study diary to record side effects and oral temperatures for 7 days following each vaccination. Blood samples will be collected before and 1 month following each dose of vaccine or placebo. Participants will be involved in study related procedures for up to 268 days.
Detailed description
Elderly individuals are at an increased risk for serious pneumococcal infection. The efficacy of the licensed pneumococcal vaccine is also lower in this at risk population. The precise immunologic reason for the increased susceptibility and decreased efficacy with advancing age is unknown. Understanding and improving the response to pneumococcal vaccine in persons over the age of 65 is an important step in preventing this serious illness. The proposed study will evaluate the relative safety and immunogenicity of 9-valent CRM 197 protein-conjugated pneumococcal polysaccharide (CRM-PS) compared to the currently licensed 23-polysaccharide (PS) vaccines in elderly adults. In addition, the response to revaccination following conjugate vaccine will also be evaluated. Outcome measurements will include adverse effects, standard ELISA measurements of serotype specific antibody, as well as antibody response to carrier protein, effects on functional antibody status and on nasal carriage of S. pneumoniae. The study will be conducted in 180 adults who are 65 years of age and older and who have not received pneumococcal vaccine within the last 5 years. Patients will be assigned to 1 of 3 groups at random in a double blind manner. One dose of vaccine and 1 dose of placebo or 2 doses of 9-valent CRM-PS vaccine will be administered at an interval of 4 months and compared to a single dose of PS vaccine and 1 dose of placebo. Subjects will be evaluated for local and system side effects using a 7-day diary card and clinical and telephone follow-up. Serologic evaluation will be done before and 1 month following each vaccination or placebo. Subjects who received CRM-PS will receive a dose of PS vaccine 8 months after the first dose of vaccine, and potential priming by previous conjugate vaccine will be assessed by measuring the quality and quantity of the antibody response to revaccination. Participants will be involved in study related procedures for up to 268 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Biological: PNU-IMUNE®23, Biological: Nine-valent pneumococcal conjugate (PNCRM9)Vaccine dose 1: CRM-PS; Vaccine dose 2 (month 4): CRM-PS; Vaccine dose 3 (month 8): PS. |
| 1 | Experimental | Drug: Placebo, Biological: PNU-IMUNE®23, Biological: Nine-valent pneumococcal conjugate (PNCRM9)Vaccine dose 1: CRM-PS; Vaccine dose 2 (month 4): saline placebo; Vaccine dose 3 (month 8): PS. |
| 3 | Active comparator | Drug: Placebo, Biological: PNU-IMUNE®23Vaccine dose 1: PS; Vaccine dose 2 (month 4): saline placebo; Vaccine dose 3 (month 8): saline placebo. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Persons age 65 years and older.
- Able to give informed consent. Informed consent will be assessed with a brief questionnaire.
- Subjects must be physically able to monitor and record side effects, including reading a digital thermometer and measuring erythema and induration, with assistance from others as needed.
- Subjects must be available for follow-up over the next 9 months
Key exclusion criteria (10 listed)
- Known previous receipt of licensed pneumococcal PS vaccination within the previous 5 years. Prior vaccination history will be obtained from current and previous health care providers, if available.
- Previous vaccination with any pneumococcal glycoconjugate vaccine.
- High risk medical condition for pneumococcus such as splenectomy, nephrotic syndrome, or lymphoma.
- Immunosuppressive diseases or immunosuppressive therapy. This includes doses of steroids greater than 10 mg daily (or its equivalent), cancer chemotherapy, or known HIV disease.
- History of idiopathic thrombocytopenic purpura.
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 |
|---|---|---|
| PlaceboSaline placebo administered in a volume of 0.5 ml intramuscularly. | Drug | 1, 3 |
| PNU-IMUNE®23The 23-valent pneumococcal vaccine (PS) vaccine will contain a mixture of 25 micrograms purified, pneumococcal polysaccharide of each of 23 serotypes of Streptococcus pneumoniae per 0.5 ml dose in isotonic saline and 0.01% thimerosal. The vaccine will be administered in a volume of 0.5 ml intramuscularly. | Biological | 1, 2, 3 |
| Nine-valent pneumococcal conjugate (PNCRM9)Cross-reactive material 197 (CRM 197) is a product of the Corynebacterium diphtheria C7. Vaccine is prepared from pneumococcal polysaccharides of types 1, 4, 5, 9V, 14, 18C, 19F, 23F (2 mcg each) and 6B (4 mcg) covalently linked to CRM197 by reductive amination. The protein-polysaccharide combination is prepared as a lyophilized powder with aluminum phosphage which is reconsitituted before use. The vaccine will be administered in a volume of 0.5 ml intramuscularly. | Biological | 1, 2 |
Primary outcome
Adverse effects.
Time frame: Duration of study.
Antibody response to carrier protein, effects on functional antibody status and on nasal carriage of S. pneumoniae.
Time frame: Before and 1 month following each vaccine or placebo.
Standard ELISA measurements of serotype specific antibody.
Time frame: Before and 1 month following each vaccine or placebo.
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 17 Oct 2014.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PNU-IMUNE®23 and Nine-valent pneumococcal conjugate (PNCRM9) in people with Pneumococcal Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites 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 4 inclusion and 10 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 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Adverse effects. (time frame: Duration of study.). The study lists 3 primary outcomes in all. 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 17 Oct 2014.