Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults
Sponsor
Emergent BioSolutions (Industry)
Overall Status
Completed
CT.gov ID
NCT03483961
Collaborator
(none)
445
3
10
29.1
148.3
5.1
Study Details
Study Description
Brief Summary
The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of various doses/formulations/and schedules of administration of PXVX0317 in healthy adults.
Primary Objective:
To assess the immune response to the vaccine
Secondary Objectives:
To assess the kinetics of the immune response to different doses/formulations/schedules To assess the persistence of immune responses to different doses/formulations/schedules To assess the effect of a booster dose of the vaccine
Safety Objective:
To assess local and systemic reactions to the vaccine and to describe the safety profile of the vaccine
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The trial will explore 8 formulation/schedule combinations of CHIKV VLP vaccine with or without Alhydrogel adjuvant, and will also explore different dose schedules of Day 1 and 15 or Day 1 and 29 or Day 29 only.
Study Design
Study Type:
Interventional
Actual Enrollment
:
445 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase 2 Parallel-Group, Randomized, Double-Blind Study to Assess the Safety and Immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV-VLP], Unadjuvanted or Alum-adjuvanted)
Actual Study Start Date
:
Apr 18, 2018
Actual Primary Completion Date
:
Sep 14, 2020
Actual Study Completion Date
:
Sep 21, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: 20 mcg/unadjuvanted (Day 1 & 29) 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) |
Biological: CHIKV VLP/unadjuvanted
Vaccine consists of virus-like particles of chikungunya virus antigens
Biological: Placebo
Placebo is vaccine diluent alone
|
| Experimental: Group 2: 6 mcg/adjuvanted (Day 1 & 29) 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) |
Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Biological: Placebo
Placebo is vaccine diluent alone
|
| Experimental: Group 3: 10 mcg/adjuvanted (Day 1 & 29) 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) |
Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Biological: Placebo
Placebo is vaccine diluent alone
|
| Experimental: Group 4: 20mcg/adjuvanted (Day 1 & 29);40mcg/adjuvant (Day 547) 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) |
Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Biological: Placebo
Placebo is vaccine diluent alone
|
| Experimental: Group 5: 6 mcg/adjuvanted (Day 15 & 29) Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) |
Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Biological: Placebo
Placebo is vaccine diluent alone
|
| Experimental: Group 6: 10 mcg/adjuvanted (Day 15 & 29) Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) |
Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Biological: Placebo
Placebo is vaccine diluent alone
|
| Experimental: Group 7: 20 mcg/adjuvanted (Day 15 & 29) Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) |
Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Biological: Placebo
Placebo is vaccine diluent alone
|
| Experimental: Group 8: 40 mcg/adjuvanted (Day 29) Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) |
Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Biological: Placebo
Placebo is vaccine diluent alone
|
| Experimental: Group 9: 20 mcg/adjuvanted (Day 1 & 29) 20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182 |
Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
|
| Experimental: Group 10: 40 mcg/adjuvanted (Day 1) 40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22. |
Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
|
Outcome Measures
Primary Outcome Measures
- Anti-CHIKV Neutralizing Antibody Geometric Mean Titer 28 Days After the Last Injection for Groups 2-8. [Day 57 (from Day 1 vaccination), 28 days after the last injection.]
To assess the induction of anti-chikungunya virus (CHIKV) neutralizing antibody geometric mean titers by different formulations and schedules, as measured at 28 days after the last injection (Day 57) for Groups 2-8.
Secondary Outcome Measures
- Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8. [At Days 8, 15, 22, 29, 36, and 57.]
To describe the kinetics of induction of anti-CHIKV neutralizing antibody geometric mean titers by different formulations and schedules for Groups 2-8.
- Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8. [At Days 182, 365, 547, and 760.]
To assess differences in persistence of neutralizing antibody geometric mean titers induced by different formulations and schedules, as measured up to 731 days after the last injection (Day 760) relative to earlier time points for Groups 2-8.
- Boosting of Vaccine-induced Neutralizing Antibody Geometric Mean Titer by a Booster Dose of PXVX0317 for Group 4 Only. [Antibody levels will be measured at Day 547 prior to the booster dose and again 28 days later on Day 575 and then at Day 760.]
To assess the effect of a booster dose of PXVX0317 on neutralizing antibody geometric mean titers when given at Day 547 for Group 4 only. Antibody levels will be measured at Day 547 prior to the booster dose and again 28 days later on Day 575 and then at Day 760.
- Percentage of Participants With an Anti-CHIKV Neutralizing Antibody Titer Exceeding the Following Cutoff Values: ≥15, 40, 160, 640, and 4-fold Rise Over Baseline. [Day 57 (from Day 1 vaccination), 28 days after the last injection.]
Percentage of participants with an anti-CHIKV neutralizing antibody titer exceeding the following cutoff values: ≥15, 40, 160, 640, and 4-fold rise over baseline.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Male or female
-
Age 18 to 45 years old (inclusive)
-
Using an acceptable method of contraception (if female of childbearing potential).
-
Able and willing to provide informed consent for study participation.
Exclusion Criteria:
-
Current acute febrile illness.
-
Clinically significant cardiac, respiratory, or rheumatologic disease, in the opinion of the Investigator.
-
Pregnant or breast-feeding.
-
Laboratory evidence of infection with Hepatitis B/C or HIV.
-
History of chikungunya virus infection.
-
Travel to a World Health Organization-designated chikungunya-endemic region within 30 days prior to Day 1.
-
History of allergic reaction to any component of CHIKV-VLP vaccine, Diluent, or Alhydrogel®.
-
Inability to discontinue systemic immunomodulatory or immunosuppressive medications 30 days prior to Day 1.
-
Received or plans to receive any licensed vaccine from 30 days prior to Day 1 through Day 57.
-
Received or plans to receive an investigational agent from 30 days prior to Day 1 through the duration of study participation.
-
Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject.
-
Any other condition that, in the opinion of the Investigator, may interfere with the conduct of the study or the validity of the data.
-
Any other condition that, in the opinion of the Investigator, creates an unacceptable safety risk for apheresis (Group 9 & 10 only).
-
Restricted venous access that would prevent the collection of PBMCs, plasma, and lymphocytes necessary for participation (Group 9 & 10 only).
-
Weight < 110 pounds (Group 9 & 10 only)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johnson County Clin-Trials | Lenexa | Kansas | United States | 66219 |
| 2 | The Center for Pharmaceutical Research | Kansas City | Missouri | United States | 64114 |
| 3 | Advanced Clinical Research | West Jordan | Utah | United States | 84088 |
Sponsors and Collaborators
- Emergent BioSolutions
Investigators
- Study Director: James McCarty, MD, Emergent BioSolutions
Study Documents (Full-Text)
- Study Protocol: Protocol Cover Page - May 22, 2020
- Study Protocol: Protocol Cover Page - May 22, 2020
- Statistical Analysis Plan: Statistical Analysis Plan Cover Page - Jul 14, 2020
- Statistical Analysis Plan: Statistical Analysis Plan Cover Page - Jul 14, 2020
- Informed Consent Form: Informed Consent Form Cover page - Jun 6, 2019
- Informed Consent Form: Informed Consent Form Cover page - Jun 6, 2019
More Information
Publications
None provided.Responsible Party:
Emergent BioSolutions
ClinicalTrials.gov Identifier:
NCT03483961
Other Study ID Numbers:
- PXVX-CV-317-001
First Posted:
Mar 30, 2018
Last Update Posted:
Nov 9, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were recruited at 3 U.S. sites. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Group 1: 20 mcg/Unadjuvant (Day 1 & 29) | Group 2: 6 mcg/Adjuvant (Day 1 & 29) | Group 3: 10 mcg/Adjuvant (Day 1 & 29) | Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) | Group 5: 6 mcg/Adjuvant (Day 15 & 29) | Group 6: 10 mcg/Adjuvant (Day 15 & 29) | Group 7: 20 mcg/Adjuvant (Day 15 & 29) | Group 8: 40 mcg/Adjuvant (Day 29) | Group 9: 20 mcg/Adjuvant (Day 1 & 29) | Group 10: 40 mcg/Adjuvant (Day 1) |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone | 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182 CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel | 40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22. CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel |
| Period Title: Overall Study | ||||||||||
| STARTED | 53 | 52 | 51 | 50 | 53 | 53 | 51 | 52 | 20 | 10 |
| Exposed / Safety | 53 | 52 | 50 | 51 | 53 | 53 | 51 | 52 | 20 | 10 |
| Immunogenicity-evaluable | 47 | 44 | 44 | 45 | 48 | 48 | 47 | 50 | 20 | 10 |
| COMPLETED | 42 | 42 | 39 | 41 | 43 | 47 | 46 | 39 | 18 | 10 |
| NOT COMPLETED | 11 | 10 | 12 | 9 | 10 | 6 | 5 | 13 | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | Group 1: 20 mcg/Unadjuvant (Day 1 & 29) | Group 2: 6 mcg/Adjuvant (Day 1 & 29) | Group 3: 10 mcg/Adjuvant (Day 1 & 29) | Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) | Group 5: 6 mcg/Adjuvant (Day 15 & 29) | Group 6: 10 mcg/Adjuvant (Day 15 & 29) | Group 7: 20 mcg/Adjuvant (Day 15 & 29) | Group 8: 40 mcg/Adjuvant (Day 29) | Group 9: 20 mcg/Adjuvant (Day 1 & 29) | Group 10: 40 mcg/Adjuvant (Day 1) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone | 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182 CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel | 40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22. CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel | Total of all reporting groups |
| Overall Participants | 53 | 52 | 51 | 50 | 53 | 53 | 51 | 52 | 20 | 10 | 445 |
| Age (Count of Participants) | |||||||||||
| <=18 years |
3
5.7%
|
1
1.9%
|
0
0%
|
0
0%
|
0
0%
|
1
1.9%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
5
1.1%
|
| Between 18 and 65 years |
50
94.3%
|
51
98.1%
|
51
100%
|
50
100%
|
53
100%
|
52
98.1%
|
51
100%
|
52
100%
|
20
100%
|
10
100%
|
440
98.9%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||||||||||
| Mean (Standard Deviation) [years] |
30.4
(8.22)
|
31.2
(8.26)
|
31.2
(7.64)
|
33.7
(7.53)
|
30.6
(7.72)
|
32.9
(7.53)
|
32.4
(7.78)
|
31.6
(7.82)
|
27.1
(7.58)
|
29.6
(7.65)
|
31.5
(7.86)
|
| Sex: Female, Male (Count of Participants) | |||||||||||
| Female |
30
56.6%
|
30
57.7%
|
37
72.5%
|
32
64%
|
38
71.7%
|
29
54.7%
|
27
52.9%
|
26
50%
|
7
35%
|
3
30%
|
259
58.2%
|
| Male |
23
43.4%
|
22
42.3%
|
14
27.5%
|
18
36%
|
15
28.3%
|
24
45.3%
|
24
47.1%
|
26
50%
|
13
65%
|
7
70%
|
186
41.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||||||
| Hispanic or Latino |
3
5.7%
|
4
7.7%
|
4
7.8%
|
3
6%
|
4
7.5%
|
8
15.1%
|
2
3.9%
|
4
7.7%
|
2
10%
|
1
10%
|
35
7.9%
|
| Not Hispanic or Latino |
50
94.3%
|
48
92.3%
|
47
92.2%
|
47
94%
|
49
92.5%
|
45
84.9%
|
49
96.1%
|
48
92.3%
|
18
90%
|
9
90%
|
410
92.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.9%
|
0
0%
|
0
0%
|
1
5%
|
0
0%
|
2
0.4%
|
| Asian |
0
0%
|
2
3.8%
|
1
2%
|
2
4%
|
0
0%
|
1
1.9%
|
0
0%
|
2
3.8%
|
1
5%
|
0
0%
|
9
2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.9%
|
0
0%
|
1
2%
|
0
0%
|
0
0%
|
0
0%
|
2
0.4%
|
| Black or African American |
10
18.9%
|
9
17.3%
|
14
27.5%
|
13
26%
|
14
26.4%
|
9
17%
|
15
29.4%
|
7
13.5%
|
7
35%
|
6
60%
|
104
23.4%
|
| White |
43
81.1%
|
40
76.9%
|
36
70.6%
|
35
70%
|
36
67.9%
|
40
75.5%
|
34
66.7%
|
41
78.8%
|
11
55%
|
4
40%
|
320
71.9%
|
| More than one race |
0
0%
|
1
1.9%
|
0
0%
|
0
0%
|
2
3.8%
|
2
3.8%
|
1
2%
|
2
3.8%
|
0
0%
|
0
0%
|
8
1.8%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||||||||
| United States |
53
100%
|
52
100%
|
51
100%
|
50
100%
|
53
100%
|
53
100%
|
51
100%
|
52
100%
|
20
100%
|
10
100%
|
445
100%
|
| Day 1 predose (baseline) geometric mean anti-chikungunya luciferase neutralizing antibody titer. (titer) [Geometric Mean (Full Range) ] | |||||||||||
| Geometric Mean (Full Range) [titer] |
7.5
|
7.5
|
7.5
|
7.5
|
7.8
|
7.5
|
7.5
|
7.5
|
8.6
|
9.0
|
7.6
|
Outcome Measures
| Title | Anti-CHIKV Neutralizing Antibody Geometric Mean Titer 28 Days After the Last Injection for Groups 2-8. |
|---|---|
| Description | To assess the induction of anti-chikungunya virus (CHIKV) neutralizing antibody geometric mean titers by different formulations and schedules, as measured at 28 days after the last injection (Day 57) for Groups 2-8. |
| Time Frame | Day 57 (from Day 1 vaccination), 28 days after the last injection. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames). |
| Arm/Group Title | Group 1: 20 mcg/Unadjuvant (Day 1 & 29) | Group 2: 6 mcg/Adjuvant (Day 1 & 29) | Group 3: 10 mcg/Adjuvant (Day 1 & 29) | Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) | Group 5: 6 mcg/Adjuvant (Day 15 & 29) | Group 6: 10 mcg/Adjuvant (Day 15 & 29) | Group 7: 20 mcg/Adjuvant (Day 15 & 29) | Group 8: 40 mcg/Adjuvant (Day 29) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone | 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone |
| Measure Participants | 47 | 44 | 44 | 45 | 48 | 48 | 47 | 50 |
| Geometric Mean (95% Confidence Interval) [titer] |
2057.0
|
1116.2
|
1465.3
|
2023.8
|
920.1
|
1206.9
|
1562.8
|
1712.5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: 20 mcg/Unadjuvant (Day 1 & 29), Group 2: 6 mcg/Adjuvant (Day 1 & 29), Group 3: 10 mcg/Adjuvant (Day 1 & 29), Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547), Group 5: 6 mcg/Adjuvant (Day 15 & 29), Group 6: 10 mcg/Adjuvant (Day 15 & 29), Group 7: 20 mcg/Adjuvant (Day 15 & 29), Group 8: 40 mcg/Adjuvant (Day 29) |
|---|---|---|
| Comments | Groups 2-8 are compared to Group 1. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0015 |
| Comments | All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values. | |
| Method | ANOVA | |
| Comments | ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 2 vs. Group 1. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 1: 20 mcg/Unadjuvant (Day 1 & 29), Group 2: 6 mcg/Adjuvant (Day 1 & 29), Group 3: 10 mcg/Adjuvant (Day 1 & 29), Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547), Group 5: 6 mcg/Adjuvant (Day 15 & 29), Group 6: 10 mcg/Adjuvant (Day 15 & 29), Group 7: 20 mcg/Adjuvant (Day 15 & 29), Group 8: 40 mcg/Adjuvant (Day 29) |
|---|---|---|
| Comments | Groups 2-8 are compared to Group 1 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0761 |
| Comments | All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values. | |
| Method | ANOVA | |
| Comments | ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 3 vs. Group 1. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 1: 20 mcg/Unadjuvant (Day 1 & 29), Group 2: 6 mcg/Adjuvant (Day 1 & 29), Group 3: 10 mcg/Adjuvant (Day 1 & 29), Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547), Group 5: 6 mcg/Adjuvant (Day 15 & 29), Group 6: 10 mcg/Adjuvant (Day 15 & 29), Group 7: 20 mcg/Adjuvant (Day 15 & 29), Group 8: 40 mcg/Adjuvant (Day 29) |
|---|---|---|
| Comments | Groups 2-8 are compared to Group 1. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9317 |
| Comments | All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values. | |
| Method | ANOVA | |
| Comments | ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 4 vs. Group 1. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Group 1: 20 mcg/Unadjuvant (Day 1 & 29), Group 2: 6 mcg/Adjuvant (Day 1 & 29), Group 3: 10 mcg/Adjuvant (Day 1 & 29), Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547), Group 5: 6 mcg/Adjuvant (Day 15 & 29), Group 6: 10 mcg/Adjuvant (Day 15 & 29), Group 7: 20 mcg/Adjuvant (Day 15 & 29), Group 8: 40 mcg/Adjuvant (Day 29) |
|---|---|---|
| Comments | Groups 2-8 are compared to Group 1. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values. | |
| Method | ANOVA | |
| Comments | ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 5 vs. Group 1. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Group 1: 20 mcg/Unadjuvant (Day 1 & 29), Group 2: 6 mcg/Adjuvant (Day 1 & 29), Group 3: 10 mcg/Adjuvant (Day 1 & 29), Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547), Group 5: 6 mcg/Adjuvant (Day 15 & 29), Group 6: 10 mcg/Adjuvant (Day 15 & 29), Group 7: 20 mcg/Adjuvant (Day 15 & 29), Group 8: 40 mcg/Adjuvant (Day 29) |
|---|---|---|
| Comments | Groups 2-8 are compared to Group 1. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0045 |
| Comments | All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values. | |
| Method | ANOVA | |
| Comments | ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 6 vs. Group 1. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Group 1: 20 mcg/Unadjuvant (Day 1 & 29), Group 2: 6 mcg/Adjuvant (Day 1 & 29), Group 3: 10 mcg/Adjuvant (Day 1 & 29), Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547), Group 5: 6 mcg/Adjuvant (Day 15 & 29), Group 6: 10 mcg/Adjuvant (Day 15 & 29), Group 7: 20 mcg/Adjuvant (Day 15 & 29), Group 8: 40 mcg/Adjuvant (Day 29) |
|---|---|---|
| Comments | Groups 2-8 are compared to Group 1. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1437 |
| Comments | All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values. | |
| Method | ANOVA | |
| Comments | ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 7 vs. Group 1. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Group 1: 20 mcg/Unadjuvant (Day 1 & 29), Group 2: 6 mcg/Adjuvant (Day 1 & 29), Group 3: 10 mcg/Adjuvant (Day 1 & 29), Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547), Group 5: 6 mcg/Adjuvant (Day 15 & 29), Group 6: 10 mcg/Adjuvant (Day 15 & 29), Group 7: 20 mcg/Adjuvant (Day 15 & 29), Group 8: 40 mcg/Adjuvant (Day 29) |
|---|---|---|
| Comments | Groups 2-8 are compared to Group 1. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3216 |
| Comments | All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values. | |
| Method | ANOVA | |
| Comments | ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 8 vs. Group 1. | |
| Title | Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8. |
|---|---|
| Description | To describe the kinetics of induction of anti-CHIKV neutralizing antibody geometric mean titers by different formulations and schedules for Groups 2-8. |
| Time Frame | At Days 8, 15, 22, 29, 36, and 57. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames). |
| Arm/Group Title | Group 1: 20 mcg/Unadjuvant (Day 1 & 29) | Group 2: 6 mcg/Adjuvant (Day 1 & 29) | Group 3: 10 mcg/Adjuvant (Day 1 & 29) | Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) | Group 5: 6 mcg/Adjuvant (Day 15 & 29) | Group 6: 10 mcg/Adjuvant (Day 15 & 29) | Group 7: 20 mcg/Adjuvant (Day 15 & 29) | Group 8: 40 mcg/Adjuvant (Day 29) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone | 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone |
| Measure Participants | 47 | 44 | 44 | 45 | 48 | 48 | 47 | 50 |
| Day 8 |
70.6
|
34.3
|
72.6
|
117.6
|
8.4
|
7.5
|
7.5
|
7.5
|
| Day 15 |
419.3
|
189.4
|
530.2
|
912.7
|
7.7
|
7.5
|
7.7
|
7.5
|
| Day 22 |
691.5
|
351.3
|
1400.2
|
2198.1
|
46.4
|
63.1
|
119.0
|
7.5
|
| Day 29 |
417.2
|
277.3
|
890.5
|
1238.1
|
258.0
|
328.8
|
886.2
|
8.2
|
| Day 36 |
3442.8
|
1675.8
|
2772.4
|
3435.0
|
1327.7
|
2155.4
|
3609.0
|
157.9
|
| Day 57 |
2057.0
|
1116.2
|
1465.3
|
2023.8
|
920.1
|
1206.9
|
1562.8
|
1712.5
|
| Title | Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8. |
|---|---|
| Description | To assess differences in persistence of neutralizing antibody geometric mean titers induced by different formulations and schedules, as measured up to 731 days after the last injection (Day 760) relative to earlier time points for Groups 2-8. |
| Time Frame | At Days 182, 365, 547, and 760. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames). |
| Arm/Group Title | Group 1: 20 mcg/Unadjuvant (Day 1 & 29) | Group 2: 6 mcg/Adjuvant (Day 1 & 29) | Group 3: 10 mcg/Adjuvant (Day 1 & 29) | Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) | Group 5: 6 mcg/Adjuvant (Day 15 & 29) | Group 6: 10 mcg/Adjuvant (Day 15 & 29) | Group 7: 20 mcg/Adjuvant (Day 15 & 29) | Group 8: 40 mcg/Adjuvant (Day 29) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone | 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone |
| Measure Participants | 47 | 44 | 44 | 45 | 48 | 48 | 47 | 50 |
| Day 182 |
345.1
|
209.0
|
358.4
|
486.6
|
253.4
|
303
|
388.1
|
505.7
|
| Day 365 |
243.4
|
137.5
|
226.7
|
336.6
|
195.2
|
246.9
|
302.0
|
491.7
|
| Day 547 |
169.2
|
NA
|
NA
|
215.7
|
NA
|
NA
|
NA
|
297.9
|
| Day 760 |
169.8
|
NA
|
NA
|
5365.1
|
NA
|
NA
|
NA
|
279.7
|
| Title | Boosting of Vaccine-induced Neutralizing Antibody Geometric Mean Titer by a Booster Dose of PXVX0317 for Group 4 Only. |
|---|---|
| Description | To assess the effect of a booster dose of PXVX0317 on neutralizing antibody geometric mean titers when given at Day 547 for Group 4 only. Antibody levels will be measured at Day 547 prior to the booster dose and again 28 days later on Day 575 and then at Day 760. |
| Time Frame | Antibody levels will be measured at Day 547 prior to the booster dose and again 28 days later on Day 575 and then at Day 760. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames). |
| Arm/Group Title | Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) |
|---|---|
| Arm/Group Description | 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone |
| Measure Participants | 47 |
| Day 547 (pre-boost) |
223.6
|
| Day 575 (post-boost) |
12325.8
|
| Day 760 (post-boost) |
5874.2
|
| Title | Percentage of Participants With an Anti-CHIKV Neutralizing Antibody Titer Exceeding the Following Cutoff Values: ≥15, 40, 160, 640, and 4-fold Rise Over Baseline. |
|---|---|
| Description | Percentage of participants with an anti-CHIKV neutralizing antibody titer exceeding the following cutoff values: ≥15, 40, 160, 640, and 4-fold rise over baseline. |
| Time Frame | Day 57 (from Day 1 vaccination), 28 days after the last injection. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames). |
| Arm/Group Title | Group 1: 20 mcg/Unadjuvant (Day 1 & 29) | Group 2: 6 mcg/Adjuvant (Day 1 & 29) | Group 3: 10 mcg/Adjuvant (Day 1 & 29) | Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) | Group 5: 6 mcg/Adjuvant (Day 15 & 29) | Group 6: 10 mcg/Adjuvant (Day 15 & 29) | Group 7: 20 mcg/Adjuvant (Day 15 & 29) | Group 8: 40 mcg/Adjuvant (Day 29) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone | 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone |
| Measure Participants | 47 | 44 | 44 | 45 | 48 | 48 | 47 | 50 |
| Titer at or above 15 |
47
88.7%
|
44
84.6%
|
44
86.3%
|
45
90%
|
48
90.6%
|
48
90.6%
|
47
92.2%
|
50
96.2%
|
| Titer at or above 40 |
47
88.7%
|
44
84.6%
|
43
84.3%
|
45
90%
|
48
90.6%
|
48
90.6%
|
47
92.2%
|
50
96.2%
|
| Titer at or above 160 |
47
88.7%
|
42
80.8%
|
43
84.3%
|
45
90%
|
47
88.7%
|
48
90.6%
|
46
90.2%
|
50
96.2%
|
| Titer at or above 640 |
43
81.1%
|
32
61.5%
|
41
80.4%
|
43
86%
|
29
54.7%
|
40
75.5%
|
41
80.4%
|
44
84.6%
|
| Titer at or above 4-fold rise over baseline |
47
88.7%
|
44
84.6%
|
43
84.3%
|
45
90%
|
48
90.6%
|
48
90.6%
|
47
92.2%
|
50
96.2%
|
Adverse Events
| Time Frame | Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses. | |||||||||||||||||||
| Arm/Group Title | Group 1: 20 mcg/Unadjuvant (Day 1 & 29) | Group 2: 6 mcg/Adjuvant (Day 1 & 29) | Group 3: 10 mcg/Adjuvant (Day 1 & 29) | Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) | Group 5: 6 mcg/Adjuvant (Day 15 & 29) | Group 6: 10 mcg/Adjuvant (Day 15 & 29) | Group 7: 20 mcg/Adjuvant (Day 15 & 29) | Group 8: 40 mcg/Adjuvant (Day 29) | Group 9: 20 mcg/Adjuvant (Day 1 & 29) | Group 10: 40 mcg/Adjuvant (Day 1) | ||||||||||
| Arm/Group Description | 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone | 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone | 20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182 CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel | 40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22. CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel | ||||||||||
All Cause Mortality |
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| Group 1: 20 mcg/Unadjuvant (Day 1 & 29) | Group 2: 6 mcg/Adjuvant (Day 1 & 29) | Group 3: 10 mcg/Adjuvant (Day 1 & 29) | Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) | Group 5: 6 mcg/Adjuvant (Day 15 & 29) | Group 6: 10 mcg/Adjuvant (Day 15 & 29) | Group 7: 20 mcg/Adjuvant (Day 15 & 29) | Group 8: 40 mcg/Adjuvant (Day 29) | Group 9: 20 mcg/Adjuvant (Day 1 & 29) | Group 10: 40 mcg/Adjuvant (Day 1) | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/53 (0%) | 0/52 (0%) | 0/50 (0%) | 0/51 (0%) | 0/53 (0%) | 0/53 (0%) | 0/51 (0%) | 0/52 (0%) | 0/20 (0%) | 0/10 (0%) | ||||||||||
Serious Adverse Events |
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| Group 1: 20 mcg/Unadjuvant (Day 1 & 29) | Group 2: 6 mcg/Adjuvant (Day 1 & 29) | Group 3: 10 mcg/Adjuvant (Day 1 & 29) | Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) | Group 5: 6 mcg/Adjuvant (Day 15 & 29) | Group 6: 10 mcg/Adjuvant (Day 15 & 29) | Group 7: 20 mcg/Adjuvant (Day 15 & 29) | Group 8: 40 mcg/Adjuvant (Day 29) | Group 9: 20 mcg/Adjuvant (Day 1 & 29) | Group 10: 40 mcg/Adjuvant (Day 1) | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/53 (0%) | 1/52 (1.9%) | 2/50 (4%) | 1/51 (2%) | 0/53 (0%) | 0/53 (0%) | 2/51 (3.9%) | 3/52 (5.8%) | 0/20 (0%) | 0/10 (0%) | ||||||||||
| Hepatobiliary disorders | ||||||||||||||||||||
| Biliary dyskinesia | 0/53 (0%) | 0 | 0/52 (0%) | 0 | 0/50 (0%) | 0 | 0/51 (0%) | 0 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 0/51 (0%) | 0 | 1/52 (1.9%) | 1 | 0/20 (0%) | 0 | 0/10 (0%) | 0 |
| Immune system disorders | ||||||||||||||||||||
| Anaphylactic reaction | 0/53 (0%) | 0 | 0/52 (0%) | 0 | 1/50 (2%) | 1 | 0/51 (0%) | 0 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 0/51 (0%) | 0 | 0/52 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||||
| Appendicitis | 0/53 (0%) | 0 | 0/52 (0%) | 0 | 0/50 (0%) | 0 | 0/51 (0%) | 0 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 0/51 (0%) | 0 | 1/52 (1.9%) | 1 | 0/20 (0%) | 0 | 0/10 (0%) | 0 |
| Gastroenteritis | 0/53 (0%) | 0 | 0/52 (0%) | 0 | 0/50 (0%) | 0 | 0/51 (0%) | 0 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 1/51 (2%) | 1 | 0/52 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 |
| Pneumonia | 0/53 (0%) | 0 | 0/52 (0%) | 0 | 0/50 (0%) | 0 | 0/51 (0%) | 0 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 0/51 (0%) | 0 | 1/52 (1.9%) | 1 | 0/20 (0%) | 0 | 0/10 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||||
| Induced abortion haemorrhage | 0/53 (0%) | 0 | 1/52 (1.9%) | 1 | 0/50 (0%) | 0 | 0/51 (0%) | 0 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 0/51 (0%) | 0 | 0/52 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 |
| Laryngeal injury | 0/53 (0%) | 0 | 0/52 (0%) | 0 | 0/50 (0%) | 0 | 1/51 (2%) | 1 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 0/51 (0%) | 0 | 0/52 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 |
| Road traffic accident | 0/53 (0%) | 0 | 0/52 (0%) | 0 | 1/50 (2%) | 1 | 0/51 (0%) | 0 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 0/51 (0%) | 0 | 0/52 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||||||||||||||||||
| Hyperemesis gravidarum | 0/53 (0%) | 0 | 0/52 (0%) | 0 | 0/50 (0%) | 0 | 0/51 (0%) | 0 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 1/51 (2%) | 1 | 0/52 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 |
| Premature separation of placenta | 0/53 (0%) | 0 | 0/52 (0%) | 0 | 0/50 (0%) | 0 | 0/51 (0%) | 0 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 1/51 (2%) | 1 | 0/52 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 |
| Threatened labour | 0/53 (0%) | 0 | 0/52 (0%) | 0 | 0/50 (0%) | 0 | 0/51 (0%) | 0 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 1/51 (2%) | 1 | 0/52 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||||||||||
| Vaginal haemorrhage | 0/53 (0%) | 0 | 0/52 (0%) | 0 | 0/50 (0%) | 0 | 0/51 (0%) | 0 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 1/51 (2%) | 1 | 0/52 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
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| Group 1: 20 mcg/Unadjuvant (Day 1 & 29) | Group 2: 6 mcg/Adjuvant (Day 1 & 29) | Group 3: 10 mcg/Adjuvant (Day 1 & 29) | Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) | Group 5: 6 mcg/Adjuvant (Day 15 & 29) | Group 6: 10 mcg/Adjuvant (Day 15 & 29) | Group 7: 20 mcg/Adjuvant (Day 15 & 29) | Group 8: 40 mcg/Adjuvant (Day 29) | Group 9: 20 mcg/Adjuvant (Day 1 & 29) | Group 10: 40 mcg/Adjuvant (Day 1) | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 26/53 (49.1%) | 35/52 (67.3%) | 36/50 (72%) | 34/51 (66.7%) | 29/53 (54.7%) | 28/53 (52.8%) | 30/51 (58.8%) | 34/52 (65.4%) | 12/20 (60%) | 4/10 (40%) | ||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||
| Toothache | 0/53 (0%) | 0 | 0/52 (0%) | 0 | 0/50 (0%) | 0 | 1/51 (2%) | 1 | 1/53 (1.9%) | 1 | 1/53 (1.9%) | 1 | 1/51 (2%) | 1 | 0/52 (0%) | 0 | 1/20 (5%) | 1 | 0/10 (0%) | 0 |
| Nausea, solicited | 8/53 (15.1%) | 9 | 6/52 (11.5%) | 10 | 8/50 (16%) | 8 | 14/51 (27.5%) | 17 | 4/53 (7.5%) | 4 | 5/53 (9.4%) | 7 | 6/51 (11.8%) | 6 | 6/52 (11.5%) | 8 | 1/20 (5%) | 1 | 0/10 (0%) | 0 |
| General disorders | ||||||||||||||||||||
| Hangover | 0/53 (0%) | 0 | 0/52 (0%) | 0 | 0/50 (0%) | 0 | 0/51 (0%) | 0 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 0/51 (0%) | 0 | 0/52 (0%) | 0 | 1/20 (5%) | 1 | 0/10 (0%) | 0 |
| Injection site pain, solicited | 19/53 (35.8%) | 25 | 27/52 (51.9%) | 41 | 23/50 (46%) | 35 | 29/51 (56.9%) | 63 | 18/53 (34%) | 25 | 18/53 (34%) | 27 | 18/51 (35.3%) | 30 | 26/52 (50%) | 32 | 10/20 (50%) | 16 | 2/10 (20%) | 2 |
| Fatigue, solicited | 11/53 (20.8%) | 16 | 12/52 (23.1%) | 18 | 12/50 (24%) | 14 | 19/51 (37.3%) | 27 | 7/53 (13.2%) | 7 | 7/53 (13.2%) | 10 | 11/51 (21.6%) | 17 | 10/52 (19.2%) | 15 | 2/20 (10%) | 2 | 2/10 (20%) | 2 |
| Malaise, solicited | 7/53 (13.2%) | 8 | 7/52 (13.5%) | 10 | 6/50 (12%) | 7 | 14/51 (27.5%) | 15 | 4/53 (7.5%) | 4 | 7/53 (13.2%) | 10 | 10/51 (19.6%) | 13 | 9/52 (17.3%) | 11 | 2/20 (10%) | 2 | 1/10 (10%) | 1 |
| Chills, solicited | 1/53 (1.9%) | 1 | 3/52 (5.8%) | 3 | 5/50 (10%) | 5 | 8/51 (15.7%) | 9 | 3/53 (5.7%) | 3 | 4/53 (7.5%) | 6 | 4/51 (7.8%) | 5 | 3/52 (5.8%) | 3 | 0/20 (0%) | 0 | 0/10 (0%) | 0 |
| Pyrexia, solicited | 0/53 (0%) | 0 | 2/52 (3.8%) | 2 | 2/50 (4%) | 2 | 4/51 (7.8%) | 4 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 0/51 (0%) | 0 | 0/52 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||||
| Upper respiratory tract infection | 4/53 (7.5%) | 4 | 2/52 (3.8%) | 2 | 1/50 (2%) | 1 | 2/51 (3.9%) | 3 | 0/53 (0%) | 0 | 4/53 (7.5%) | 4 | 2/51 (3.9%) | 2 | 4/52 (7.7%) | 4 | 1/20 (5%) | 1 | 0/10 (0%) | 0 |
| Gastroenteritis | 0/53 (0%) | 0 | 1/52 (1.9%) | 1 | 1/50 (2%) | 1 | 0/51 (0%) | 0 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 4/51 (7.8%) | 4 | 1/52 (1.9%) | 1 | 0/20 (0%) | 0 | 0/10 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||
| Myalgia, solicited | 11/53 (20.8%) | 12 | 12/52 (23.1%) | 15 | 12/50 (24%) | 18 | 21/51 (41.2%) | 35 | 11/53 (20.8%) | 14 | 10/53 (18.9%) | 18 | 11/51 (21.6%) | 19 | 11/52 (21.2%) | 11 | 0/20 (0%) | 0 | 2/10 (20%) | 2 |
| Arthralgia, solicited | 3/53 (5.7%) | 4 | 9/52 (17.3%) | 11 | 4/50 (8%) | 6 | 12/51 (23.5%) | 16 | 3/53 (5.7%) | 4 | 4/53 (7.5%) | 7 | 4/51 (7.8%) | 8 | 6/52 (11.5%) | 6 | 1/20 (5%) | 1 | 1/10 (10%) | 1 |
| Nervous system disorders | ||||||||||||||||||||
| Presyncope | 0/53 (0%) | 0 | 0/52 (0%) | 0 | 0/50 (0%) | 0 | 0/51 (0%) | 0 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 0/51 (0%) | 0 | 0/52 (0%) | 0 | 1/20 (5%) | 1 | 0/10 (0%) | 0 |
| Headache, solicited | 11/53 (20.8%) | 14 | 14/52 (26.9%) | 23 | 18/50 (36%) | 21 | 20/51 (39.2%) | 31 | 11/53 (20.8%) | 12 | 11/53 (20.8%) | 17 | 14/51 (27.5%) | 19 | 19/52 (36.5%) | 26 | 3/20 (15%) | 4 | 1/10 (10%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||
| Oropharyngeal pain | 0/53 (0%) | 0 | 0/52 (0%) | 0 | 0/50 (0%) | 0 | 2/51 (3.9%) | 2 | 0/53 (0%) | 0 | 0/53 (0%) | 0 | 0/51 (0%) | 0 | 0/52 (0%) | 0 | 0/20 (0%) | 0 | 1/10 (10%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
PI may publish or release study data after the earlier of (a) the date of publication of a multi-center publication coordinated by Sponsor on the study data, or (b) the date of submission of the study data by Sponsor to regulatory authorities for regulatory approval; provided that PI furnishes Sponsor with a copy of any proposed publication or release at least ninety days in advance of the proposed submission or presentation date for review. PI must acknowledge Sponsor on any publication.
Results Point of Contact
| Name/Title | Sharmila Rajendran |
|---|---|
| Organization | Emergent BioSolutions |
| Phone | 650-486-0244 |
| rajendras@ebsi.com |
Responsible Party:
Emergent BioSolutions
ClinicalTrials.gov Identifier:
NCT03483961
Other Study ID Numbers:
- PXVX-CV-317-001
First Posted:
Mar 30, 2018
Last Update Posted:
Nov 9, 2021
Last Verified:
Oct 1, 2021