Chikungunya Virus InfectionPhase 2NCT03483961

Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults

A Phase 2 study testing CHIKV VLP/unadjuvanted and CHIKV VLP/adjuvanted in people with Chikungunya Virus Infection, run by Bavarian Nordic at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Chikungunya Virus Infection
What is being tested?: CHIKV VLP/unadjuvanted and CHIKV VLP/adjuvanted
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 445 participants
Where: 3 sitesUnited States
Study dates: 18 Apr 2018to 21 Sep 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 15Show fewer

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)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Advanced Clinical Research
West Jordan, Utah, 84088

Other trials in United States

About this study

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)

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

Read the 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.

Conditions: Chikungunya Virus Infection
Being tested: CHIKV VLP/unadjuvanted, CHIKV VLP/adjuvanted, Placebo
Medical subject headings: Chikungunya Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CHIKV VLP/unadjuvantedBiological
Vaccine consists of virus-like particles of chikungunya virus antigens
CHIKV VLP/adjuvantedBiological
Adjuvanted formulation includes Alhydrogel
PlaceboBiological
Placebo is vaccine diluent alone

Study groups in NCT03483961
Study group	Role	What they receive
Group 1: 20 mcg/unadjuvanted (Day 1 & 29)	Experimental	20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) Receives: Biological: CHIKV VLP/unadjuvanted; Biological: Placebo
Group 2: 6 mcg/adjuvanted (Day 1 & 29)	Experimental	6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) Receives: Biological: CHIKV VLP/adjuvanted; Biological: Placebo
Group 3: 10 mcg/adjuvanted (Day 1 & 29)	Experimental	10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) Receives: Biological: CHIKV VLP/adjuvanted; Biological: Placebo
Group 4: 20mcg/adjuvanted (Day 1 & 29);40mcg/adjuvant (Day 547)	Experimental	20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) Receives: Biological: CHIKV VLP/adjuvanted; Biological: Placebo
Group 5: 6 mcg/adjuvanted (Day 15 & 29)	Experimental	Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) Receives: Biological: CHIKV VLP/adjuvanted; Biological: Placebo
Group 6: 10 mcg/adjuvanted (Day 15 & 29)	Experimental	Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) Receives: Biological: CHIKV VLP/adjuvanted; Biological: Placebo
Group 7: 20 mcg/adjuvanted (Day 15 & 29)	Experimental	Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) Receives: Biological: CHIKV VLP/adjuvanted; Biological: Placebo
Group 8: 40 mcg/adjuvanted (Day 29)	Experimental	Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) Receives: Biological: CHIKV VLP/adjuvanted; Biological: Placebo
Group 9: 20 mcg/adjuvanted (Day 1 & 29)	Experimental	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 Receives: Biological: CHIKV VLP/adjuvanted
Group 10: 40 mcg/adjuvanted (Day 1)	Experimental	40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22. Receives: Biological: CHIKV VLP/adjuvanted

What is being measured

The primary outcome is the main question the study is designed to answer.

Anti-CHIKV Neutralizing Antibody Geometric Mean Titer 28 Days After the Last Injection for Groups 2-8.
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.
Measured: Day 57 (from Day 1 vaccination), 28 days after the last injection.

Secondary outcomes (4)

Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8.
To describe the kinetics of induction of anti-CHIKV neutralizing antibody geometric mean titers by different formulations and schedules for Groups 2-8.
Measured: At Days 8, 15, 22, 29, 36, and 57.
Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8.
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.
Measured: At Days 182, 365, 547, and 760.
Boosting of Vaccine-induced Neutralizing Antibody Geometric Mean Titer by a Booster Dose of PXVX0317 for Group 4 Only.
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.
Measured: 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.
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.
Measured: Day 57 (from Day 1 vaccination), 28 days after the last injection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 201821 Sep 2020

First posted30 Mar 2018
Study start18 Apr 2018
Primary completion14 Sep 2020
Study completion21 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chikungunya Virus InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 445 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03483961
Sponsor's protocol ID: PXVX-CV-317-001
Status last verified: Jun 2023
First submitted: 16 Mar 2018
Last updated: 3 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Bennett SR, McCarty JM, Ramanathan R, Mendy J, Richardson JS, Smith J, Alexander J, Ledgerwood JE, de Lame PA, Royalty Tredo S, Warfield KL, Bedell L. Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial. Lancet Infect Dis. 2022 Sep;22(9):1343-1355. doi: 10.1016/S1473-3099(22)00226-2. Epub 2022 Jun 13.
PubMed 35709798

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingPhase 2
Evaluation of IXCHIQ® Vaccine Immunogenicity
Healthy Adult, Healthy Adolescents
RecruitingPhase 4
Real-world Effectiveness, Safety & Immunogenicity of Chikungunya Vaccination: Ambispective Study in Reunion & French Guiana
Chikungunya Virus Infection
Recruiting
Against Chikungunya Virus and Neonatal Infection
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Enrolling by invitation
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All Chikungunya Virus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03483961
Acronym / sponsor ID: PXVX-CV-317-001
Conditions: Chikungunya Virus Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 445 participants (actual)
Lead sponsor: Bavarian NordicIndustry (pharma, biotech, devices)
Collaborators: Emergent BioSolutions
Study start: 18 Apr 2018 (actual)
Primary completion: 14 Sep 2020 (actual)
Study completion: 21 Sep 2020 (actual)
First posted: 30 Mar 2018 (actual)
Results: Posted 9 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Safety Objective:

To assess local and systemic reactions to the vaccine and to describe the safety profile of the vaccine

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
Group 1: 20 mcg/unadjuvanted (Day 1 & 29)	Experimental	Biological: CHIKV VLP/unadjuvanted, Biological: Placebo20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29)
Group 2: 6 mcg/adjuvanted (Day 1 & 29)	Experimental	Biological: CHIKV VLP/adjuvanted, Biological: Placebo6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
Group 3: 10 mcg/adjuvanted (Day 1 & 29)	Experimental	Biological: CHIKV VLP/adjuvanted, Biological: Placebo10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
Group 4: 20mcg/adjuvanted (Day 1 & 29);40mcg/adjuvant (Day 547)	Experimental	Biological: CHIKV VLP/adjuvanted, Biological: Placebo20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547)
Group 5: 6 mcg/adjuvanted (Day 15 & 29)	Experimental	Biological: CHIKV VLP/adjuvanted, Biological: PlaceboPlacebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
Group 6: 10 mcg/adjuvanted (Day 15 & 29)	Experimental	Biological: CHIKV VLP/adjuvanted, Biological: PlaceboPlacebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
Group 7: 20 mcg/adjuvanted (Day 15 & 29)	Experimental	Biological: CHIKV VLP/adjuvanted, Biological: PlaceboPlacebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29)
Group 8: 40 mcg/adjuvanted (Day 29)	Experimental	Biological: CHIKV VLP/adjuvanted, Biological: PlaceboPlacebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29)
Group 9: 20 mcg/adjuvanted (Day 1 & 29)	Experimental	Biological: CHIKV VLP/adjuvanted20 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
Group 10: 40 mcg/adjuvanted (Day 1)	Experimental	Biological: CHIKV VLP/adjuvanted40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CHIKV VLP/unadjuvantedVaccine consists of virus-like particles of chikungunya virus antigens	Biological	Group 1: 20 mcg/unadjuvanted (Day 1 & 29)
CHIKV VLP/adjuvantedAdjuvanted formulation includes Alhydrogel	Biological	Group 10: 40 mcg/adjuvanted (Day 1), Group 2: 6 mcg/adjuvanted (Day 1 & 29), Group 3: 10 mcg/adjuvanted (Day 1 & 29), Group 4: 20mcg/adjuvanted (Day 1 & 29);40mcg/adjuvant (Day 547), Group 5: 6 mcg/adjuvanted (Day 15 & 29), Group 6: 10 mcg/adjuvanted (Day 15 & 29), Group 7: 20 mcg/adjuvanted (Day 15 & 29), Group 8: 40 mcg/adjuvanted (Day 29), Group 9: 20 mcg/adjuvanted (Day 1 & 29)
PlaceboPlacebo is vaccine diluent alone	Biological	Group 1: 20 mcg/unadjuvanted (Day 1 & 29), Group 2: 6 mcg/adjuvanted (Day 1 & 29), Group 3: 10 mcg/adjuvanted (Day 1 & 29), Group 4: 20mcg/adjuvanted (Day 1 & 29);40mcg/adjuvant (Day 547), Group 5: 6 mcg/adjuvanted (Day 15 & 29), Group 6: 10 mcg/adjuvanted (Day 15 & 29), Group 7: 20 mcg/adjuvanted (Day 15 & 29), Group 8: 40 mcg/adjuvanted (Day 29)

Primary outcome

Anti-CHIKV Neutralizing Antibody Geometric Mean Titer 28 Days After the Last Injection for Groups 2-8.
Time frame: 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.

4 secondary outcomes

Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8.
Time frame: At Days 8, 15, 22, 29, 36, and 57.
Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8.
Time frame: At Days 182, 365, 547, and 760.
Boosting of Vaccine-induced Neutralizing Antibody Geometric Mean Titer by a Booster Dose of PXVX0317 for Group 4 Only.
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.
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.

Results and safety

Results posted to the registry on 9 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: 20 mcg/Unadjuvant (Day 1 & 29)	53	42
Group 2: 6 mcg/Adjuvant (Day 1 & 29)	52	42
Group 3: 10 mcg/Adjuvant (Day 1 & 29)	51	39
Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547)	50	41
Group 5: 6 mcg/Adjuvant (Day 15 & 29)	53	43
Group 6: 10 mcg/Adjuvant (Day 15 & 29)	53	47
Group 7: 20 mcg/Adjuvant (Day 15 & 29)	51	46
Group 8: 40 mcg/Adjuvant (Day 29)	52	39
Group 9: 20 mcg/Adjuvant (Day 1 & 29)	20	18
Group 10: 40 mcg/Adjuvant (Day 1)	10	10

Primary outcome: Anti-CHIKV Neutralizing Antibody Geometric Mean Titer 28 Days After the Last Injection for Groups 2-8.

Time frame: Day 57 (from Day 1 vaccination), 28 days after the last injection.. Geometric mean (95% Confidence Interval). Unit: titer

Measure	Group 1: 20 mcg/Unadjuvant (Day 1 & 29) n = 47	Group 2: 6 mcg/Adjuvant (Day 1 & 29) n = 44	Group 3: 10 mcg/Adjuvant (Day 1 & 29) n = 44	Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) n = 45	Group 5: 6 mcg/Adjuvant (Day 15 & 29) n = 48	Group 6: 10 mcg/Adjuvant (Day 15 & 29) n = 48	Group 7: 20 mcg/Adjuvant (Day 15 & 29) n = 47	Group 8: 40 mcg/Adjuvant (Day 29) n = 50
Value	2057.0 (1584.8 to 2670.0)	1116.2 (852.5 to 1461.4)	1465.3 (1119.1 to 1918.4)	2023.8 (1550.5 to 2641.7)	920.1 (710.9 to 1190.9)	1206.9 (932.4 to 1562.2)	1562.8 (1204.1 to 2028.3)	1712.5 (1330.0 to 2205.0)

Group 1: 20 mcg/Unadjuvant (Day 1 & 29) vs Group 2: 6 mcg/Adjuvant (Day 1 & 29) vs Group 3: 10 mcg/Adjuvant (Day 1 & 29) vs Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) vs Group 5: 6 mcg/Adjuvant (Day 15 & 29) vs Group 6: 10 mcg/Adjuvant (Day 15 & 29) vs Group 7: 20 mcg/Adjuvant (Day 15 & 29) vs Group 8: 40 mcg/Adjuvant (Day 29): p = 0.0015, ANOVA
Group 1: 20 mcg/Unadjuvant (Day 1 & 29) vs Group 2: 6 mcg/Adjuvant (Day 1 & 29) vs Group 3: 10 mcg/Adjuvant (Day 1 & 29) vs Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) vs Group 5: 6 mcg/Adjuvant (Day 15 & 29) vs Group 6: 10 mcg/Adjuvant (Day 15 & 29) vs Group 7: 20 mcg/Adjuvant (Day 15 & 29) vs Group 8: 40 mcg/Adjuvant (Day 29): p = 0.0761, ANOVA
Group 1: 20 mcg/Unadjuvant (Day 1 & 29) vs Group 2: 6 mcg/Adjuvant (Day 1 & 29) vs Group 3: 10 mcg/Adjuvant (Day 1 & 29) vs Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) vs Group 5: 6 mcg/Adjuvant (Day 15 & 29) vs Group 6: 10 mcg/Adjuvant (Day 15 & 29) vs Group 7: 20 mcg/Adjuvant (Day 15 & 29) vs Group 8: 40 mcg/Adjuvant (Day 29): p = 0.9317, ANOVA

Population analysed: 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).

4 secondary outcomes are reported in the full results.

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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: 20 mcg/Unadjuvant (Day 1 & 29)	0 of 53 (0%)	26 of 53 (49.1%)	0 of 53
Group 2: 6 mcg/Adjuvant (Day 1 & 29)	1 of 52 (1.9%)	35 of 52 (67.3%)	0 of 52
Group 3: 10 mcg/Adjuvant (Day 1 & 29)	2 of 50 (4%)	36 of 50 (72%)	0 of 50
Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547)	1 of 51 (2%)	34 of 51 (66.7%)	0 of 51
Group 5: 6 mcg/Adjuvant (Day 15 & 29)	0 of 53 (0%)	29 of 53 (54.7%)	0 of 53
Group 6: 10 mcg/Adjuvant (Day 15 & 29)	0 of 53 (0%)	28 of 53 (52.8%)	0 of 53
Group 7: 20 mcg/Adjuvant (Day 15 & 29)	2 of 51 (3.9%)	30 of 51 (58.8%)	0 of 51
Group 8: 40 mcg/Adjuvant (Day 29)	3 of 52 (5.8%)	34 of 52 (65.4%)	0 of 52
Group 9: 20 mcg/Adjuvant (Day 1 & 29)	0 of 20 (0%)	12 of 20 (60%)	0 of 20
Group 10: 40 mcg/Adjuvant (Day 1)	0 of 10 (0%)	4 of 10 (40%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35709798Bennett SR, McCarty JM, Ramanathan R, Mendy J, Richardson JS, Smith J, Alexander J, Ledgerwood JE, de Lame PA, Royalty Tredo S, Warfield KL, Bedell L. Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial. Lancet Infect Dis. 2022 Sep;22(9):1343-1355. doi: 10.1016/S1473-3099(22)00226-2. Epub 2022 Jun 13.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James McCarty, MD study director

Emergent BioSolutions

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CHIKV VLP/unadjuvanted and CHIKV VLP/adjuvanted in people with Chikungunya Virus Infection, run by Bavarian Nordic at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-CHIKV Neutralizing Antibody Geometric Mean Titer 28 Days After the Last Injection for Groups 2-8. (time frame: Day 57 (from Day 1 vaccination), 28 days after the last injection.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03483961, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.