A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317

Sponsor

Emergent BioSolutions (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05072080

Collaborator

(none)

3,150

Enrollment

Locations

Arms

Anticipated Duration (Months)

65.6

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this multi-center, randomized, double blind, placebo controlled study is to evaluate the safety and immunogenicity of PXVX0317 in healthy adult and adolescent subjects.

Condition or Disease	Intervention/Treatment	Phase
Chikungunya Virus	Biological: CHIKV VLP/adjuvant Biological: Placebo	Phase 3

Detailed Description

Primary Objectives:

To evaluate the safety of PXVX0317 in healthy adult and adolescent subjects 12 to <65 years of age.
To compare the chikungunya virus (CHIKV) serum neutralizing antibody (SNA) response to PXVX0317 and placebo at Day 22, as measured by geometric mean titer (GMT) and clinically relevant difference in seroresponse rate.
To demonstrate the consistency of the anti-CHIKV SNA response across three lots of PXVX0317 at Day 22.

Secondary Objectives:

To compare the anti-CHIKV SNA response to PXVX0317 and placebo at Day 8, Day 15, and Day
To compare the anti-CHIKV SNA response to PXVX0317 and placebo in subjects 12 to <18 years of age, subjects 18 to <46 years of age, and subjects 46 to <65 years of age.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Subjects will be randomized in a 2:2:2:1 ratio within each age stratum (12 to <18, 18 to <46, and 46 to <65). This study will be conducted in the US, using up to 50 sites.Subjects will be randomized in a 2:2:2:1 ratio within each age stratum (12 to <18, 18 to <46, and 46 to <65). This study will be conducted in the US, using up to 50 sites.

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

A Phase 3 Safety, Immunogenicity, and Lot-Consistency Trial of the VLP-Based Chikungunya Vaccine PXVX0317 in Healthy Adults and Adolescents

Actual Study Start Date :

Sep 29, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Group 1 - PXVX0317 lot A	Biological: CHIKV VLP/adjuvant PXVX0317 vaccine is comprised of chikungunya virus-like particles (CHIKV VLP), adsorbed on Alhydrogel® adjuvant 2%
Experimental: Group 2 Group 2 - PXVX0317 lot B	Biological: CHIKV VLP/adjuvant PXVX0317 vaccine is comprised of chikungunya virus-like particles (CHIKV VLP), adsorbed on Alhydrogel® adjuvant 2%
Experimental: Group 3 Group 3 - PXVX0317 lot C	Biological: CHIKV VLP/adjuvant PXVX0317 vaccine is comprised of chikungunya virus-like particles (CHIKV VLP), adsorbed on Alhydrogel® adjuvant 2%
Placebo Comparator: Group 4 Group 4 - Placebo	Biological: Placebo Placebo is comprised of formulation buffer

Outcome Measures

Primary Outcome Measures

Incidence of solicited Adverse Events (AE) [8 days]
Incidence of solicited AEs through Day 8 for PXVX0317 and placebo for all age strata combined (safety population).
Incidence of unsolicited AEs [29 days]
Incidence of unsolicited AEs through Day 29 for PXVX0317 and placebo for all age strata combined (safety population).
Incidence of Adverse Events of Special Interest (AESI) [183 days]
Incidence of AESIs, through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).
Incidence of Medically Attended Adverse Event (MAAE) [183 days]
Incidence of MAAEs through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).
Incidence of Serious Adverse Event (SAE) [183 days]
Incidence of SAEs through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).
CHIKV serum neutralizing antibody (SNA) seroresponse rates at Day 22 [22 days]
CHIKV SNA seroresponse rates for PXVX0317 and placebo, difference (PXVX0317 minus placebo), and associated 95% confidence interval (CI) at Day 22 for the IEP population, all age strata combined.
CHIKV SNA geometric mean titers (GMT) at Day 22 [22 days]
CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 and placebo for the IEP population, all age strata combined.
CHIKV SNA GMT ratios between pairs of PXVX0317 lots at Day 22 [22 days]
CHIKV SNA GMT ratios and associated 95% CIs between all three pairs of PXVX0317 lots (A:B, A:C, B:C) in adults 18 to <46 years of age in the IEP population at Day 22.

Secondary Outcome Measures

CHIKV SNA seroresponse rates at Days 8, 15, and 183 [183 days]
CHIKV SNA seroresponse rates for PXVX0317 and placebo, difference (PXVX0317 minus placebo), and associated 95% CIs at Day 8, Day 15, and Day 183 for the IEP population, all age strata combined.
CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183 [183 days]
CHIKV SNA GMTs with associated 95% CIs at Day 8, Day 15, and Day 183 for PXVX0317 and placebo for the IEP population, all age strata combined.
Geometric Mean Fold Increase (GMFI) in CHIKV SNA titers from Day 1 to Days 8, 15, 22, and 183 [183 days]
Geometric mean fold increase (GMFI) in CHIKV SNA titers from Day 1 to Day 8, Day 15, Day 22, and Day 183 for the IEP population for all age strata combined.
Number and percentage of subjects with CHIKV SNA titers at or above selected thresholds at Days 8, 15, 22, and 183 [183 days]
Number and percentage of subjects with CHIKV SNA titers ≥15, 60, 100, 160, 640, and 4-fold rise over baseline thresholds at Day 8, Day 15, Day 22, and Day 183 for the IEP population for all age strata combined.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by subject (and guardian, as applicable).
Males or females, 12 to <65 years of age.
Generally healthy, in the opinion of the Investigator, based on medical history, physical examination, and screening laboratory assessments.
Women who are either: (i) Not of childbearing potential (CBP): pre-menarche, surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or post-menopausal (defined as a history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment) or (ii) Meeting all the below criteria: Negative serum pregnancy test at screening visit, Negative urine pregnancy test immediately prior to dosing at Day 1, Using an acceptable method of contraception (if women of CBP) for the duration of participation, such as hormonal contraceptives (e.g., implants, pills, patches) initiated ≥30 days prior to dosing, intrauterine device (IUD) inserted ≥30 days prior to dosing, double barrier type of birth control (male condom with female diaphragm, male condom with cervical cap), Abstinence is acceptable only for adolescents (12-<18 years old) who are not sexually active.

Exclusion Criteria:

Currently pregnant, breastfeeding, or planning to become pregnant during the study.
Body Mass Index (BMI) ≥35 kg/m2.
Positive laboratory evidence of current infection with human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus (HCV) or hepatitis B virus (HBV).
History of severe allergic reaction or anaphylaxis to any component of the vaccine.
History of any known congenital or acquired immunodeficiency that could impact response to vaccination (e.g., leukemia, lymphoma, generalized malignancy, functional or anatomic asplenia, alcoholic cirrhosis).
Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from six months prior to screening through Day 22. Note: For systemic corticosteroids, use at a dose or equivalent dose of 20 mg of prednisone daily for 14 days or more within three months of screening through Day 22 is exclusionary. The use of inhaled, intranasal, topical, ocular, or intraocular steroids is allowed.
Receipt or anticipated receipt of blood or blood-derived products from 90 days prior to screening through Day 22.
Acute disease within the last 14 days (subjects with an acute mild febrile illness can be considered for a deferral of vaccination two weeks after the illness has resolved and treatment has been completed).
Clinically significant cardiac, pulmonary, rheumatologic, or other chronic disease, in the opinion of the Investigator. This may include chronic illness requiring hospitalization in the last 30 days prior to screening.
Enrollment in an interventional study and/or receipt of another investigational product from 30 days prior to screening through the duration of study participation.
Receipt or anticipated receipt of any vaccine from 30 days prior to Day 1 through Day

Evidence of substance abuse that, in the opinion of the Investigator, could adversely impact the subject's participation or the conduct of the study.
Prior receipt of an investigational CHIKV vaccine/product.
Any other medical condition that, in the opinion of the Investigator, could adversely impact the subject's participation or the conduct of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Optimal Research, LLC	Huntsville	Alabama	United States	35802
2	Alliance for Multispecialty Research - Mobile	Mobile	Alabama	United States	36608
3	Alliance for Multispecialty Research, LLC	Tempe	Arizona	United States	85281
4	Velocity Clinical Research, Banning	Banning	California	United States	92220
5	Optimal Research, LLC	San Diego	California	United States	92108
6	Lynn Institute of the Rockies	Colorado Springs	Colorado	United States	80918
7	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
8	Accel Research Sites-DeLand Clinical Research Unit	Lake Mary	Florida	United States	32746
9	Optimal Research, LLC	Melbourne	Florida	United States	32934
10	Suncoast Research Associates, LLC	Miami	Florida	United States	33173
11	Synexus Clinical Research US, Inc.	Pinellas Park	Florida	United States	33781
12	Palm Beach Research Center	West Palm Beach	Florida	United States	33409
13	Emory University School of Medicine	Atlanta	Georgia	United States	30322
14	Velocity Clinical Research, Boise	Meridian	Idaho	United States	83642
15	Synexus Clinical Research US, Inc.	Chicago	Illinois	United States	60602
16	Optimal Research LLC	Peoria	Illinois	United States	61614
17	Johnson County ClinTrials	Lenexa	Kansas	United States	66219
18	Alliance for Multispecialty Research, LLC	Newton	Kansas	United States	67114
19	Alliance for Multispecialty Research - Wichita East	Wichita	Kansas	United States	67207
20	Alliance for Multispecialty Research, LLC	Lexington	Kentucky	United States	40509
21	Alliance for Multispecialty Research, LLC	New Orleans	Louisiana	United States	70119
22	Optimal Research, LLC	Rockville	Maryland	United States	20850
23	Alliance for Multispecialty Research - Kansas City	Kansas City	Missouri	United States	64114
24	Saint Louis University	Saint Louis	Missouri	United States	63104
25	Synexus Clinical Research US, Inc.	Saint Louis	Missouri	United States	63141
26	Wr-Crcn, Llc	Las Vegas	Nevada	United States	89106
27	Alliance for Multispecialty Research, LLC.	Las Vegas	Nevada	United States	89119
28	Rochester Clinical Research, Inc.	Rochester	New York	United States	14609
29	M3 Wake Research, Inc	Raleigh	North Carolina	United States	27612
30	Trial Management Associates, LLC	Wilmington	North Carolina	United States	28403
31	Synexus Clinical Research US, Inc.	Akron	Ohio	United States	44311
32	Cincinnati Children's Hospital Medical Center - The Gamble Vaccine Research Center	Cincinnati	Ohio	United States	45229
33	Velocity Clinical Rsearch, Inc.	Cleveland	Ohio	United States	44122
34	Aventiv Research Inc.	Columbus	Ohio	United States	43213
35	Lynn Institute of Norman	Norman	Oklahoma	United States	73072
36	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
37	Velocity Clinical Research, Medford	Medford	Oregon	United States	97504
38	Velocity Clinical Research-Providence	East Greenwich	Rhode Island	United States	02818
39	Synexus Clinical Research US, Inc.	Anderson	South Carolina	United States	29621
40	Coastal Carolina Research Center	North Charleston	South Carolina	United States	29405
41	Alliance for Multispecialty Research, LLC	Knoxville	Tennessee	United States	37920
42	Velocity Clinical Research, Austin	Cedar Park	Texas	United States	78613
43	Texas Center for Drug Development, Inc.	Houston	Texas	United States	77081
44	Research Your Health	Plano	Texas	United States	75093
45	BFHC Research	San Antonio	Texas	United States	78249
46	DM Clinical Research	Tomball	Texas	United States	77375
47	Advanced Clinical Research	West Jordan	Utah	United States	84088
48	Alliance for Multispecialty Research, LLC	Norfolk	Virginia	United States	23502