Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age (B1971042)
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01768117
First received: January 8, 2013
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
This study will assess the safety, tolerability and immunogenicity of bivalent rLP2086 vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6 schedule. The study will recruit laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program. The study will provide descriptive safety and immunogenicity data following vaccination of these individuals with bivalent rLP2086 vaccine.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningitis, Meningococcal, Serogroup B |
Biological: rLP2086 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Single-Arm, Open-Label Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Proportion of subjects with titer ≥ lower limit of quantitation (LLOQ) for each of the 4 primary test strains at 1 month after the third vaccination with bivalent rLP2086 vaccine. [ Time Frame: 7 Months ] [ Designated as safety issue: No ]
- Percentage of subjects reporting local reactions and systemic events for 7 days after each vaccination visit. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
- Percentage of subjects reporting the use of antipyrectic medication for 7 days after each vaccination visit [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
- Percentage of subjects with at least 1 SAE 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
- Percentage of subjects with at least 1 medically attended adverse event 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
- Percentage of subjects with at least 1 newly diagnosed chronic medical condition 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
- Percentage of subjects with at least 1 adverse event 30 days after each vaccination, 30 days after any vaccination and during the vaccination phase. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
- Percentage of subjects reporting at least 1 immediate AE after each vaccination. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
- Subject's days missing school or work due to AEs during the vaccination phase [ Time Frame: 7 Months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Proportion of subjects with a titer ≥ lower limit of quantitation for each of the 4 primary test strains 1 month after the first vaccination with bivalent rLP2086 vaccine. [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
- Proportion of subjects with a titer ≥ lower limit of quantitation for each of the 4 primary test strains 1 month after the second vaccination with bivalent rLP2086 vaccine. [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
- Proportion of subjects with a titer ≥ lower limit of quantitation for each of the 4 primary test strains immediately prior to the third vaccination with bivalent rLP2086 vaccine. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: rLP2086 |
Biological: rLP2086
0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program.
- Male or female subject aged ≥18 to ≤65 years at the time of enrollment.
- Negative urine pregnancy test.
Exclusion Criteria:
- Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
- A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency are excluded from participation in this study.
- Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- Current chronic use of systemic antibiotics.
- Received any investigational drugs, vaccines, or devices within 28 days before administration of the first study vaccination.
- Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
- Prior receipt of any vaccine specifically targeting fHBP or LP2086 antigens.
- History of microbiologically proven disease caused by Neisseria meningitidis.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768117
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| United States, New Jersey | |
| Pfizer Investigational Site | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | Not yet recruiting |
| Collegeville, Pennsylvania, United States, 19426 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01768117 History of Changes |
| Other Study ID Numbers: | B1971042 |
| Study First Received: | January 8, 2013 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Meningitis Meningitis, Meningococcal Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Meningitis, Bacterial |
Central Nervous System Bacterial Infections Bacterial Infections Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections |
ClinicalTrials.gov processed this record on May 22, 2013