Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination
Chikungunya Virus Infection
About this trial
This is an interventional prevention trial for Chikungunya Virus Infection focused on measuring Chikungunya, PXVX0317, Vaccine, Immunogenicity, CHIKV VLP
Eligibility Criteria
Inclusion Criteria: Within the feeder study informed consent form (ICF) (and/or assent form, as applicable), the participant voluntarily signed and agreed to be contacted by the sponsor for potential screening and enrollment in a future study (ie, EBSI-CV-317-008). Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by participant (and guardian, as applicable) for participation in this rollover study EBSI-CV-317-008, including possible receipt of a booster dose of PXVX0317. Males or females, 12 to <65 years of age at the time of enrollment in the feeder study. Received a single dose of PXVX0317 vaccine in the feeder study. Demonstrated compliance to the feeder study conduct (ie, rollover participant was without protocol deviations that excluded them from analysis in feeder study EBSI-CV-317-004) without discontinuation or early withdrawal. Generally healthy, in the opinion of the investigator, based on medical history and physical examination. Additional inclusion criteria to be assessed at Prerandomization Visit (Visit 5) and Randomization Visit (Visit 6) to determine eligibility for a booster: - Women who are either: i. Not of childbearing potential (CBP): premenarche, surgically sterile (at least six weeks postbilateral tubal ligation or bilateral total salpingectomy, bilateral oophorectomy, or hysterectomy), or postmenopausal (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). For women who are postmenopausal, documented follicle stimulating hormone (FSH) level of ≥40 mIU/mL must be obtained. If the FSH is <40 mIU/mL, the participant must agree to use an acceptable form of contraception. or: ii. Meet all the below criteria: Negative serum pregnancy test at Prerandomization Visit Negative urine pregnancy test at Prebooster Visit and immediately prior to booster dose administration Use one of these acceptable methods of contraception (if women of CBP) for at least six months after booster: Hormonal contraceptives (eg, implants, pills, patches) initiated ≥30 days prior to booster dose administration Intrauterine device (IUD) inserted ≥30 days prior to booster dose administration 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 of age) who are not sexually active. Women participants of CBP must use an acceptable method of contraception from ≥30 days prior to randomization through six-months postbooster vaccination dose (if applicable). Note: Contraception requirements do not apply for participants in exclusively same-sex relationships and these participants should have no plans to become pregnant by any other means for the duration of the study. Contraception requirements do not apply to Group 4 participants (unrandomized or unboosted). Exclusion Criteria: Received placebo treatment in the feeder study. Measurable anti-CHIKV SNA at Day 1 in the feeder study. History of severe allergic reaction or anaphylaxis to any component of the investigational product (IP). Receipt of either an investigational or licensed CHIKV vaccine (excluding prior receipt of PXVX0317). New onset/diagnosis of any disease falling within the feeder study exclusion criteria including: i. History of any known congenital or acquired immunodeficiency that could impact response to vaccination (eg, leukemia, lymphoma, generalized malignancy, functional or anatomic asplenia, alcoholic cirrhosis) or ii. Clinically significant cardiac, pulmonary, rheumatologic, or other chronic disease, in the opinion of the investigator. This may include chronic illness requiring hospitalization during the feeder study. Evidence of substance abuse that, in the opinion of the investigator, could adversely impact the individual's participation or the conduct of the study. Any other medical condition or general reason that, in the opinion of the investigator, could adversely impact the individual's participation or the conduct of the study. Participation or planned participation in an investigational clinical trial, excluding feeder study EBSI-CV-317-004 (eg, vaccine, drug, medical device, or medical procedure) for the duration of this study. Note: Participation in an observational trial or follow-up phase of a trial may be allowed; however, these instances should be discussed with this study's medical monitor (MM). Additional exclusion criteria to be assessed at Prerandomization Visit (Visit 5), Randomization Visit (Visit 6), and Prebooster (for Groups 2 and 3) Visit(s) to determine eligibility for a booster: Positive laboratory evidence of current infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV). Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from six months prior to Prebooster Visit through 21 days after booster dose. 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 Prebooster Visit through 21 days postbooster dose 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 Prebooster Visit through 21 days postbooster dose. Acute disease within the last 14 days prior to booster dose (participants 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). Receipt or anticipated receipt of any vaccine from 30 days prior to booster dose through 21 days postbooster. Experienced a related safety event in the feeder study that, in the investigator's judgement, precludes receipt of booster. Note: Participants that are ineligible or decline booster will be included in Group 4 (unrandomized or unboosted) for follow-up unless consent/assent for follow-up is withdrawn.
Sites / Locations
- Wr-Crcn, LlcRecruiting
- Rochester Clinical Research, LLCRecruiting
- M3 Wake Research Inc.Recruiting
- Lynn Institute of NormanRecruiting
- DM Clinical ResearchRecruiting
- DM Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
No Intervention
Group 1a
Group 1b
Group 2a
Group 2b
Group 3a
Group 3b
Group 4
PXVX0317 vaccine booster, 3 years post initial vaccination
Placebo booster, 3 years post initial vaccination
PXVX0317 vaccine booster, 4 years post initial vaccination
Placebo booster, 4 years post initial vaccination
PXVX0317 vaccine booster, 5 years post initial vaccination
Placebo booster, 5 years post initial vaccination
Unrandomized or unboosted participants, for any reason