Trial Outcomes & Findings for Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age (NCT NCT01768117)

NCT ID: NCT01768117

Last Updated: 2018-12-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 13 participants
• Primary outcome timeframe: 1 month after vaccination 3
• Results posted on: 2018-12-20

Participant Flow

Participant milestones

Measure	rLP2086 Enrolled to receive on a 0, 2-, 6- month schedule
Overall Study STARTED	13
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	rLP2086 Enrolled to receive on a 0, 2-, 6- month schedule
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	2
Overall Study Protocol Violation	3

Baseline Characteristics

Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age

Baseline characteristics by cohort

Measure	rLP2086 n=13 Participants Enrolled to receive on a 0, 2-, 6- month schedule
Age, Customized 18- 40 years	5 participants n=93 Participants
Age, Customized Greater than (>) 40 years	8 participants n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1 month after vaccination 3

Outcome measures

Measure	rLP2086 n=6 Participants Enrolled to receive on a 0, 2-, 6- month schedule
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 Interval 54.1 to 100.0
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 Interval 47.8 to 100.0
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 Interval 54.1 to 100.0
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 Interval 11.8 to 88.2

PRIMARY outcome

Timeframe: Vaccination 1 up to 1 month after Vaccination 3

Outcome measures

Measure	rLP2086 n=13 Participants Enrolled to receive on a 0, 2-, 6- month schedule
Percentage of Participants With at Least One Adverse Event (AE)	46.2 percentage of participants

SECONDARY outcome

Timeframe: 1 month after vaccination (Vac) 1, 2, Immediately prior to vaccination 3

Outcome measures

Measure	rLP2086 n=6 Participants Enrolled to receive on a 0, 2-, 6- month schedule
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
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
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
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
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
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
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
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
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 Interval 11.8 to 88.2
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 Interval 22.3 to 95.7
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 Interval 54.1 to 100.0
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 Interval 4.3 to 77.7

SECONDARY outcome

Timeframe: 1 month after vaccination 3

Outcome measures

Measure	rLP2086 n=5 Participants Enrolled to receive on a 0, 2-, 6- month schedule
Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined	3 participants Interval 14.7 to 94.7

SECONDARY outcome

Timeframe: 1 month after vaccination 3

Outcome measures

Measure	rLP2086 n=6 Participants Enrolled to receive on a 0, 2-, 6- month schedule
Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level PMB80 [A22] (N=6)	5 participants Interval 35.9 to 99.6
Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level PMB2001 [A56] (N=5)	5 participants Interval 47.8 to 100.0
Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level PMB2948 [B24] (N=6)	4 participants Interval 22.3 to 95.7
Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level PMB2707 [B44] (N=6)	3 participants Interval 11.8 to 88.2

Adverse Events

rLP2086

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	rLP2086 n=13 participants at risk Enrolled to receive on a 0, 2-, 6- month schedule
Eye disorders Eye Pain	7.7% 1/13 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086). SAE reported from Vaccination 1 to 6 months after last administration of investigational product (bivalent rLP2086) Events collected on case report form were reported.
Infections and infestations Respiratory tract infection viral	7.7% 1/13 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086). SAE reported from Vaccination 1 to 6 months after last administration of investigational product (bivalent rLP2086) Events collected on case report form were reported.
Infections and infestations Urinary tract infection	7.7% 1/13 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086). SAE reported from Vaccination 1 to 6 months after last administration of investigational product (bivalent rLP2086) Events collected on case report form were reported.
Infections and infestations Upper respiratory tract infection	7.7% 1/13 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086). SAE reported from Vaccination 1 to 6 months after last administration of investigational product (bivalent rLP2086) Events collected on case report form were reported.
Nervous system disorders Presyncope	7.7% 1/13 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086). SAE reported from Vaccination 1 to 6 months after last administration of investigational product (bivalent rLP2086) Events collected on case report form were reported.
Musculoskeletal and connective tissue disorders Gouty arthritis	14.3% 1/7 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086). SAE reported from Vaccination 1 to 6 months after last administration of investigational product (bivalent rLP2086) Events collected on case report form were reported.
General disorders Chills	7.7% 1/13 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086). SAE reported from Vaccination 1 to 6 months after last administration of investigational product (bivalent rLP2086) Events collected on case report form were reported.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER