Phase 1
N=86
Immunogenicity and Reactogenicity of Pneumococcal Polysaccharide and Conjugate Vaccines in Native Elders
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00153543 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Immune Responses — 1.95; 1.69; 1.22; 0.78 ug/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PCV7 + PPV23, 2 months (Biological); PCV7 + PPV23, 6 months (Biological)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Centers for Disease Control and Prevention
- Primary completion
- Jun 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immune Responses |
1.95; 1.69; 1.22; 0.78; 1.23; .8 | — |
| SECONDARY Number of Participants With Systemic and Injection Site Reactions |
2; 10; 7; 6; 20; 17 | — |
Summary
To test the hypothesis that immune responses to 23-valent pneumococcal polysaccharide vaccine (PPV-23) could be improved in Alaska Native elders by immune priming with 7-valent pneumococcal conjugate vaccine (PCV-7), we assessed post-vaccination immune responses among Natives aged 55 years and older who were randomized into three arms: (1) one dose of PPV-23 according to current state and ACIP recommendations; (2) one dose of PCV-7 followed two months later with a dose of PPV-23; and (3) one dose of PCV-7 followed six months later with a dose of PPV-23.
Eligibility Criteria
Inclusion Criteria
- Age 55 to 70 years
- Alaska Native
Exclusion Criteria
- Immune compromising condition
- Neurological disease
- Immune suppressive medication or immunoglobulin within 6 months
- Previous pneumococcal vaccination
Data sourced from ClinicalTrials.gov (NCT00153543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.