Meningitis, Meningococcal, Serogroup B
Conditions
Brief summary
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.
Interventions
BIOLOGICALrLP2086
0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program. 2. Male or female subject aged ≥18 to ≤65 years at the time of enrollment. 3. Negative urine pregnancy test.
Exclusion criteria
1. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. 2. 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. 3. Significant neurological disorder or history of seizure (excluding simple febrile seizure). 4. Current chronic use of systemic antibiotics. 5. Received any investigational drugs, vaccines, or devices within 28 days before administration of the first study vaccination. 6. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. 7. Prior receipt of any vaccine specifically targeting fHBP or LP2086 antigens. 8. History of microbiologically proven disease caused by Neisseria meningitidis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) | 1 month after vaccination 3 |
| Percentage of Participants With at Least One Adverse Event (AE) | Vaccination 1 up to 1 month after Vaccination 3 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ | 1 month after vaccination (Vac) 1, 2, Immediately prior to vaccination 3 |
| Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined | 1 month after vaccination 3 |
| Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level | 1 month after vaccination 3 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| rLP2086 Enrolled to receive on a 0, 2-, 6- month schedule | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | rLP2086 |
|---|---|
| Age, Customized 18- 40 years | 5 participants |
| Age, Customized Greater than (>) 40 years | 8 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
Time frame: 1 month after vaccination 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) | PMB80 [A22] 1:16 (N=6) | 6 participants |
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) | PMB2001 [A56] 1:8 (N=5) | 5 participants |
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) | PMB2948 [B24] 1:8 (N=6) | 6 participants |
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) | PMB2707 [B44] 1:8 (N=6) | 3 participants |
Primary
Percentage of Participants With at Least One Adverse Event (AE)
Time frame: Vaccination 1 up to 1 month after Vaccination 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rLP2086 | Percentage of Participants With at Least One Adverse Event (AE) | 46.2 percentage of participants |
Secondary
Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level
Time frame: 1 month after vaccination 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rLP2086 | Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level | PMB80 [A22] (N=6) | 5 participants |
| rLP2086 | Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level | PMB2001 [A56] (N=5) | 5 participants |
| rLP2086 | Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level | PMB2948 [B24] (N=6) | 4 participants |
| rLP2086 | Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level | PMB2707 [B44] (N=6) | 3 participants |
Secondary
Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ
Time frame: 1 month after vaccination (Vac) 1, 2, Immediately prior to vaccination 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ | Immediately prior to Vac 3: PMB2948 [B24] 1:8(N=6) | 5 participants |
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ | 1 month after Vac 1: PMB80 [A22] 1:16 (N=6) | 3 participants |
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ | 1 month after Vac 2: PMB80 [A22] 1:16 (N=5) | 3 participants |
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ | Immediately prior to Vac 3: PMB80 [A22] 1:16 (N=6) | 4 participants |
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ | 1 month after Vac 1: PMB2001 [A56] 1:8 (N=6) | 4 participants |
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ | 1 month after Vac 2: PMB2001 [A56] 1:8 (N=6) | 6 participants |
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ | Immediately prior to Vac 3: PMB2001 [A56] 1:8(N=6) | 4 participants |
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ | 1 month after Vac 1: PMB2948 [B24] 1:8 (N=6) | 6 participants |
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ | 1 month after Vac 2: PMB2948 [B24] 1:8 (N=6) | 6 participants |
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ | 1 month after Vac 1: PMB2707 [B44] 1:8 (N=6) | 2 participants |
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ | 1 month after Vac 2: PMB2707 [B44] 1:8 (N=6) | 3 participants |
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ | Immediately prior to Vac 3: PMB2707 [B44] 1:8(N=6) | 2 participants |
Secondary
Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined
Time frame: 1 month after vaccination 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rLP2086 | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined | 3 participants |