Campylobacter InfectionPhase 1NCT05500417
Safety and Immunogenicity of CJCV2 With and Without ALFQ
A Phase 1 study testing ALFQ and CJCV2 in people with Campylobacter Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This is a randomized, double-blind, dose-escalating, outpatient trial in a total of approximately 60 subjects, assigned to 3 cohorts (20 subjects per cohort). Each subject will receive one of three intramuscular (IM) vaccinations, spaced 28 days apart, of Campylobacter jejuni Conjugate Vaccine (CJCV2) with or without… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Campylobacter Infection
- What is being tested?
- ALFQ and CJCV2
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2022to 2 Jan 2025
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide informed consent prior to initiation of any study procedures.
- Able to understand and comply with planned study procedures and be available for all study visits/safety communications.
- Non-pregnant/non-lactating subjects 18-50 years of age inclusive upon enrollment.
- In general, good health* to be safely enrolled in this study as determined by medical history, medication use**, and physical exam.
- Good health is defined by the absence of any exclusionary medical conditions. If the subject has another current, ongoing medical condition, the condition cannot meet any of the following criteria; 1) first diagnosed within 3 months of enrollment; 2) is worsening in terms of clinical outcome in last 6 months; or 3) involves need for medication that may pose a risk to subject's safety or impede assessment of AEs or immunogenicity if they participate in the study.
- Topical, nasal, and inhaled medications (with the exception of inhaled corticosteroids as outlined in the Subject Exclusion #17). Herbals, vitamins, and supplements are permitted.
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- Oral temperature is less than 100.4 degrees F.
- Pulse is 50 to 100 beats per minute (bpm), inclusive.
- Systolic blood pressure (BP) is 90 to 140 mmHg, inclusive.
- Diastolic BP is 55 to 90 mmHg, inclusive.
- Body Mass Index(BMI) less than 40.
- Females of childbearing potential* may enroll if subject has practiced adequate contraception** > 30 days prior to enrollment and agrees to continue adequate contraception for the entire study.
- Child-bearing potential is defined as not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure (R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year of the last menses if menopausal.
- Adequate contraception includes; non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the first study vaccination, barrier methods such as condoms or diaphragms with spermicide, effective intrauterine devices, NuvaRing (R), and licensed hormonal methods such as implants, injectables, or oral contraceptives ("the pill").
- Females of childbearing potential must have a negative urine pregnancy test within 24 hours prior to enrollment.
- Agree not to participate in another interventional clinical trial during the study period that may affect the analysis or endpoint assessment.
- Negative urine drug screen for opiates.
Who cannot join
- Have any disease or medical condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation*.
- Including acute or chronic disease or medical condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
- These include:
- History of inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, indeterminate colitis, or celiac disease). Within the past 12 months, has any of the following: irritable bowel syndrome (IBS) or any active uncontrolled gastrointestinal disorders or diseases as assessed by the investigator, including symptoms or evidence of active gastritis or gastroesophageal reflux disease, gastric surgery or gastric acid hyper-secretory disorders (e.g., Zollinger-Ellison syndrome), gastrointestinal obstruction, ileus, gastric retention, bowel perforation, toxic colitis, persistent infectious gastroenteritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection. History of immunodeficiency due to congenital or hereditary causes, underlying illness or treatment, autoimmune disorders, or chronic inflammatory disorders. History of an inflammatory arthritis such as reactive arthritis, Reiter's syndrome, ankylosing spondylitis, rheumatoid arthritis, or GBS. Known active neoplastic disease non-melanoma, treated, skin cancers are permitted, a history of any hematologic malignancy, or have used anticancer chemotherapy/radiation therapy (cytotoxic) within 5 years prior to study vaccination. Other condition requiring daily therapy that would place the volunteer at increased risk or Adverse Events (AE). Other laboratory abnormalities which in the opinion of the investigator precludes participation in the study. Clinically significant abnormalities on physical exam.
- Documented history of auto-immune conditions in a first-degree relative. Examples include reactive arthritis, Reiter's syndrome, ankylosing spondylitis, rheumatoid arthritis, or GBS.
- History of Potentially Immune-Mediated Medical Conditions (PIMMCs).
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- Evidence of inflammatory arthritis on exam and/or positive serology results for HLA-B27.
- Positive Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCVs).
- Participation in a previous Campylobacter study or reports having received vaccination against Campylobacter within the last 3 years.
- History of microbiologically confirmed Campylobacter infection in the last 3 years.
- Occupation involving handling of Campylobacter bacteria or vaccine products currently or in the past 3 years.
- Use of immunosuppressive/immunomodulating disease therapy within 90 days
- Received Immunoglobulin (Ig) or other blood products (with exception of Rho D Ig) within 90 days prior to enrollment.
- Have a history of severe reactions following previous immunization with any licensed or unlicensed vaccine.
- Known hypersensitivity to any components of vaccine, adjuvant or diluent.
- Received or plan to receive a licensed live vaccine within 30 days prior to 1st vaccination and to 30 days after the last vaccination.
- Received or plan to receive a licensed, inactivated, vaccine within 14 days prior to 1st vaccination to 14 days after the last vaccination, or a seasonal influenza and/or COVID-19 vaccine +/- 7 days from study product vaccination.
- Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is unacceptably obscured due to a physical condition or permanent body art.
- Within 14 days prior to vaccination has received an oral or parenteral (including intra-articular) corticosteroid of any dose for 5 or more days, or high-dose inhaled corticosteroids. a) High dose defined per age as using inhaled high dose per reference chart (https://www.nhlbi.nih.gov/files/docs/guidelines/asthma_qrg.pdf)
- Current or history of alcohol or drug abuse within one year prior to enrollment.
- Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
- Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within one year prior to enrollment.
- Are pregnant, breastfeeding, or plan to become pregnant or breastfeed at any given time during the study.
- Have an acute illness as determined by study clinician licensed to make medical diagnoses and listed on the Form FDA 1572 as the site PI or sub-investigator, within 72 hours prior to enrollment.
- An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of a study clinician licensed to make medical diagnoses and listed on the Form FDA 1572 as the site PI or sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
- Received an investigational product within 30 days prior to the first study vaccination or expect to receive an investigational product during the study period.
- Including vaccine, drug, biologic, device, blood product, or medication, other than from participation in this trial.
- Have abnormal screening laboratory values within 30 days prior to enrollment. a. Screening laboratory values that are outside acceptable range but are thought to be due to an acute condition or due to laboratory error may be repeated once.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center Vaccine Research Center
Cincinnati, Ohio, 45229-3039
About this study
Official title: First-in-Human Safety and Immunogenicity Evaluation of an Intramuscular Campylobacter Jejuni Conjugate Vaccine (CJCV2) With and Without Army Liposome Formulation Containing QS-21 (ALFQ)
This is a randomized, double-blind, dose-escalating, outpatient trial in a total of approximately 60 subjects, assigned to 3 cohorts (20 subjects per cohort). Each subject will receive one of three intramuscular (IM) vaccinations, spaced 28 days apart, of Campylobacter jejuni Conjugate Vaccine (CJCV2) with or without a fixed dose of the adjuvant Army Liposome Formulation containing QS-21 (ALFQ)(200 mcg 3D-PHAD, 100 mcg QS-21). Three doses (1 ug, 3 ug and 10 ug) of CJCV2 will be evaluated. The first six participants at each dose will be sentinels and randomized in a 1:1 blinded fashion to receive CJCV2 with or without ALFQ. The primary objective is to evaluate the safety of the three different doses of IM injection of CJCV2 with and without ALFQ. The study hypothesis is that the CJCV2 vaccine alone and CJCV2 with ALFQ adjuvant will be safe and that the CJCV2 alone will be immunogenic, with immunogenicity enhanced through the use of the adjuvant ALFQ.
Read the detailed description
This is a randomized, double-blind, dose-escalating, outpatient trial in a total of approximately 60 subjects, assigned to 3 cohorts (20 subjects per cohort). Each subject will receive one of three intramuscular (IM) vaccinations, spaced 28 days apart, of Campylobacter jejuni Conjugate Vaccine (CJCV2) with or without a fixed dose of the adjuvant Army Liposome Formulation containing QS-21 (ALFQ)(200 mcg 3D-PHAD, 100 mcg QS-21).Three doses (1 ug, 3 ug and 10 ug) of CJCV2 will be evaluated. The first six participants at each dose will be sentinels and randomized in a 1:1 blinded fashion to receive CJCV2 with or without ALFQ. The primary objective is to evaluate the safety of the three different doses of IM injection of CJCV2 with and without ALFQ. The secondary objective is to evaluate C. jejuni capsule-specific serum IgG responses following vaccination. The study hypothesis is that the CJCV2 vaccine alone and CJCV2 with ALFQ adjuvant will be safe and that the CJCV2 alone will be immunogenic, with immunogenicity enhanced through the use of the adjuvant ALFQ.
- Conditions
- Campylobacter Infection
- Being tested
- ALFQ, CJCV2
- Keywords
- ALFQ, Campylobacter jejuni, Campylobacter jejuni Conjugate Vaccine, CJCV2, Immunogenicity, QS-21, safety
- Medical subject headings
- Campylobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALFQDrug
ALFQ (Army Liposome Formulation containing QS-21) is composed of ALF55 (cGMP-manufactured Army Liposome Formulation), QS-21 (purified extracted saponin), and Sorensen's Phosphate Buffer. Full dose of AFLQ compromised of 200 microgram 3D-PHAD and 100 microgram QS-21, co-administered with main intervention.
CJCV2Biological
Vaccine comprised of C. jejuni capsule conjugated to Cross-Reactive Material 197 (CRM197), a non-toxic mutant protein of diphtheria toxin. CJCV2 will be reconstituted in 1 mL of sterile water for injection (SWI). The resuspended CJCV2 product will be diluted with sterile 0.9% Sodium Chloride for Injection. 3 dosages for administration: 1 microgram, 3 micrograms, and 10 micrograms.
| Study group | Role | What they receive |
|---|---|---|
| Group 1A | Experimental | Each subject will receive a 1 mL intramuscular (IM) injection containing 1 microgram of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10 Receives: Biological: CJCV2 |
| Group 1B | Experimental | Each subject will receive a 1 mL intramuscular (IM) injection containing 1 microgram of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) and a full dose of Army Liposome Formulation containing QS-21 (ALFQ) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10 Receives: Drug: ALFQ; Biological: CJCV2 |
| Group 2A | Experimental | Each subject will receive a 1 mL intramuscular (IM) injection containing 3 micrograms of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10 Receives: Biological: CJCV2 |
| Group 2B | Experimental | Each subject will receive a 1 mL intramuscular (IM) injection containing 3 micrograms of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) and a full dose of Army Liposome Formulation containing QS-21 (ALFQ) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10 Receives: Drug: ALFQ; Biological: CJCV2 |
| Group 3A | Experimental | Each subject will receive a 1 mL intramuscular (IM) injection containing 10 micrograms of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10 Receives: Biological: CJCV2 |
| Group 3B | Experimental | Each subject will receive a 1 mL intramuscular (IM) injection containing 10 micrograms of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) and a full dose of Army Liposome Formulation containing QS-21 (ALFQ) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10 Receives: Drug: ALFQ; Biological: CJCV2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Participants With Solicited Local Adverse Events (AEs) Through 7 Days After Each Study Vaccination
Solicited local AEs were collected 30 minutes post-vaccination, and then daily for 7 days after each vaccination using a memory aid and graded on a scale of 0 (none), 1 (mild), 2 (moderate) and 3 (severe). Local symptoms included ecchymosis, ecchymosis (measurement), erythema, erythema (measurement), induration/edema, induration/edema (measurement), pain, and tenderness.
Measured: Days 1 through 8, Days 29 through 36, and Days 57 through 64
Number and Percentage of Participants With Solicited Systemic Adverse Events (AEs) Through 7 Days After Each Study Vaccination
Solicited systemic AEs were collected prior to vaccination, 30 minutes post-vaccination, and then daily for 7 days after each vaccination using a memory aid and graded on a scale of 0 (none), 1 (mild), 2 (moderate) and 3 (severe). Systemic symptoms included arthralgia, fatigue, fever, feverishness (chills/shivering/sweating), headache, malaise, myalgia, nausea, and vomiting.
Measured: Days 1 through 8, Days 29 through 36, and Days 57 through 64
Number and Percentage of Participants With Vaccine-related Unsolicited AEs Through 28 Days Post Last Vaccination
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, regardless of its causal relationship to the study treatment. The FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. The occurrence of an AE could have come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
An AE was considered related if there was a reasonable possibility that the study product caused the AE. Reasonable possibility means that there was evidence to suggest a causal relationship between the study product and the AE.
Measured: Day 1 through Day 85
Number and Percentage of Participants With Serious Adverse Events (SAEs)
An AE or suspected adverse reaction was considered a SAE if, in the view of either the PI or sponsor, it resulted in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not have resulted in these outcomes could be considered serious when, based upon appropriate medical judgment, they could have jeopardized the participant and could have required medical or surgical intervention to prevent one of the outcomes listed in this definition.
Measured: Day 1 through Day 420
Number and Percentage of Participants With Medically Attended Adverse Events (MAAEs) From First Study Vaccination Through End of Study Participation
Medically attended adverse events (MAAEs) are any unsolicited AE for which a participant received medical attention, defined as hospitalization, an ER visit, or an otherwise unscheduled visit to or from medical personnel.
Measured: Day 1 through Day 420
Number and Percentage of Participants With New-onset Chronic Medical Conditions (NOCMCs) From First Study Vaccination Through End of Study Participation
New-onset chronic medical conditions (NOCMCs) are defined as any new ICD-10 diagnosis that is applied to the participant during the duration of the study, after receipt of the study product, that is expected to continue for at least 3 months and requires continued health care intervention.
Measured: Day 1 through Day 420
Number and Percentage of Participants With Potentially Immune-mediated Medical Conditions (PIMMCs) From First Study Vaccination Through End of Study Participation
Potentially immune-mediated medical conditions (PIMMCs) constitute a group of AEs that includes diseases which are clearly autoimmune in etiology and other inflammatory and/or neurologic disorders which may or may not have autoimmune etiologies.
Measured: Day 1 through Day 420
Secondary outcomes (3)
Percentage of Participants With >= 4-fold Rise From Baseline in C. Jejuni Capsule-specific Immunoglobulin G (IgG) Serum Antibodies
Serum from blood collected at Study Days 1, 8, 29, 36, 57, 64, 85, and 113 was analyzed using an enzyme-linked immunosorbent assay (ELISA) to measure C. jejuni capsule-specific Immunoglobulin G (IgG) serum antibody titers. Results below the lower limit of quantification (LLOQ) were imputed as LLOQ/2. The percentage of participants with at least a 4-fold rise in antibody titer compared to pre-vaccination 1 is presented by arm with exact 95% Clopper-Pearson confidence interval.
Measured: Days 8, 29, 36, 57, 64, 85, and 113
Peak Fold Rise From Baseline in C. Jejuni Capsule-specific Immunoglobulin G (IgG) Serum Antibody Titer
Serum from blood collected at Study Days 1, 8, 29, 36, 57, 64, 85, and 113 was analyzed using an enzyme-linked immunosorbent assay (ELISA) to measure C. jejuni capsule-specific Immunoglobulin G (IgG) serum antibody titers. Results below the lower limit of quantification (LLOQ) were imputed as LLOQ/2. For each participant, peak fold-rise from baseline is defined as the maximum fold-rise in antibody titer that occurred throughout all follow-up visits with available data (Day 8 up to Day 113) as compared to baseline (Day 1). The peak fold-rise from baseline per participant is summarized by study arm via geometric mean and 95% confidence interval based on Student's t distribution.
Measured: Day 8 through Day 113
Maximum C. Jejuni Capsule-specific Immunoglobulin G (IgG) Serum Antibody Titer
Serum from blood collected at Study Days 1, 8, 29, 36, 57, 64, 85, and 113 was analyzed using an enzyme-linked immunosorbent assay (ELISA) to measure C. jejuni capsule-specific Immunoglobulin G (IgG) serum antibody titers. Results below the lower limit of quantification (LLOQ) were imputed as LLOQ/2. For each participant, the maximum antibody titer measured throughout all follow-up visits with available data (Day 8 up to Day 113) was recorded. The maximum post-baseline titer per participant is summarized by study arm via geometric mean and 95% confidence interval based on Student's t distribution.
Measured: Day 8 through Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start13 Sep 2022
- Primary completion2 Jan 2025
- Study completion2 Jan 2025
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.
- Other trials for Campylobacter InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500417
- Sponsor's protocol ID
- 19-0003
- Other IDs
- 5UM1AI148372-03
- Status last verified
- 7 Feb 2025
- First submitted
- 11 Aug 2022
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human Safety and Immunogenicity Evaluation of an Intramuscular Campylobacter Jejuni Conjugate Vaccine (CJCV2) With and Without Army Liposome Formulation Containing QS-21 (ALFQ)
- ClinicalTrials.gov ID
- NCT05500417
- Acronym / sponsor ID
- 19-0003
- Conditions
- Campylobacter Infection
- Keywords
- ALFQ, Campylobacter jejuni, Campylobacter jejuni Conjugate Vaccine, CJCV2, Immunogenicity, QS-21, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Posted 30 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, dose-escalating, outpatient trial in a total of approximately 60 subjects, assigned to 3 cohorts (20 subjects per cohort). Each subject will receive one of three intramuscular (IM) vaccinations, spaced 28 days apart, of Campylobacter jejuni Conjugate Vaccine (CJCV2) with or without a fixed dose of the adjuvant Army Liposome Formulation containing QS-21 (ALFQ)(200 mcg 3D-PHAD, 100 mcg QS-21). Three doses (1 ug, 3 ug and 10 ug) of CJCV2 will be evaluated. The first six participants at each dose will be sentinels and randomized in a 1:1 blinded fashion to receive CJCV2 with or without ALFQ. The primary objective is to evaluate the safety of the three different doses of IM injection of CJCV2 with and without ALFQ. The study hypothesis is that the CJCV2 vaccine alone and CJCV2 with ALFQ adjuvant will be safe and that the CJCV2 alone will be immunogenic, with immunogenicity enhanced through the use of the adjuvant ALFQ.
Detailed description
This is a randomized, double-blind, dose-escalating, outpatient trial in a total of approximately 60 subjects, assigned to 3 cohorts (20 subjects per cohort). Each subject will receive one of three intramuscular (IM) vaccinations, spaced 28 days apart, of Campylobacter jejuni Conjugate Vaccine (CJCV2) with or without a fixed dose of the adjuvant Army Liposome Formulation containing QS-21 (ALFQ)(200 mcg 3D-PHAD, 100 mcg QS-21).Three doses (1 ug, 3 ug and 10 ug) of CJCV2 will be evaluated. The first six participants at each dose will be sentinels and randomized in a 1:1 blinded fashion to receive CJCV2 with or without ALFQ. The primary objective is to evaluate the safety of the three different doses of IM injection of CJCV2 with and without ALFQ. The secondary objective is to evaluate C. jejuni capsule-specific serum IgG responses following vaccination. The study hypothesis is that the CJCV2 vaccine alone and CJCV2 with ALFQ adjuvant will be safe and that the CJCV2 alone will be immunogenic, with immunogenicity enhanced through the use of the adjuvant ALFQ.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1A | Experimental | Biological: CJCV2Each subject will receive a 1 mL intramuscular (IM) injection containing 1 microgram of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10 |
| Group 1B | Experimental | Drug: ALFQ, Biological: CJCV2Each subject will receive a 1 mL intramuscular (IM) injection containing 1 microgram of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) and a full dose of Army Liposome Formulation containing QS-21 (ALFQ) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10 |
| Group 2A | Experimental | Biological: CJCV2Each subject will receive a 1 mL intramuscular (IM) injection containing 3 micrograms of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10 |
| Group 2B | Experimental | Drug: ALFQ, Biological: CJCV2Each subject will receive a 1 mL intramuscular (IM) injection containing 3 micrograms of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) and a full dose of Army Liposome Formulation containing QS-21 (ALFQ) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10 |
| Group 3A | Experimental | Biological: CJCV2Each subject will receive a 1 mL intramuscular (IM) injection containing 10 micrograms of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10 |
| Group 3B | Experimental | Drug: ALFQ, Biological: CJCV2Each subject will receive a 1 mL intramuscular (IM) injection containing 10 micrograms of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) and a full dose of Army Liposome Formulation containing QS-21 (ALFQ) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Provide informed consent prior to initiation of any study procedures.
- Able to understand and comply with planned study procedures and be available for all study visits/safety communications.
- Non-pregnant/non-lactating subjects 18-50 years of age inclusive upon enrollment.
- In general, good health* to be safely enrolled in this study as determined by medical history, medication use**, and physical exam.
- Good health is defined by the absence of any exclusionary medical conditions. If the subject has another current, ongoing medical condition, the condition cannot meet any of the following criteria; 1) first diagnosed within 3 months of enrollment; 2) is worsening in terms of clinical outcome in last 6 months; or 3) involves need for medication that may pose a risk to subject's safety or impede assessment of AEs or immunogenicity if they participate in the study.
Key exclusion criteria (28 listed)
- Have any disease or medical condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation*.
- Including acute or chronic disease or medical condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
- History of inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, indeterminate colitis, or celiac disease). Within the past 12 months, has any of the following: irritable bowel syndrome (IBS) or any active uncontrolled gastrointestinal disorders or diseases as assessed by the investigator, including symptoms or evidence of active gastritis or gastroesophageal reflux disease, gastric surgery or gastric acid hyper-secretory disorders (e.g., Zollinger-Ellison syndrome), gastrointestinal obstruction, ileus, gastric retention, bowel perforation, toxic colitis, persistent infectious gastroenteritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection. History of immunodeficiency due to congenital or hereditary causes, underlying illness or treatment, autoimmune disorders, or chronic inflammatory disorders. History of an inflammatory arthritis such as reactive arthritis, Reiter's syndrome, ankylosing spondylitis, rheumatoid arthritis, or GBS. Known active neoplastic disease non-melanoma, treated, skin cancers are permitted, a history of any hematologic malignancy, or have used anticancer chemotherapy/radiation therapy (cytotoxic) within 5 years prior to study vaccination. Other condition requiring daily therapy that would place the volunteer at increased risk or Adverse Events (AE). Other laboratory abnormalities which in the opinion of the investigator precludes participation in the study. Clinically significant abnormalities on physical exam.
- Documented history of auto-immune conditions in a first-degree relative. Examples include reactive arthritis, Reiter's syndrome, ankylosing spondylitis, rheumatoid arthritis, or GBS.
- History of Potentially Immune-Mediated Medical Conditions (PIMMCs).
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 |
|---|---|---|
| ALFQALFQ (Army Liposome Formulation containing QS-21) is composed of ALF55 (cGMP-manufactured Army Liposome Formulation), QS-21 (purified extracted saponin), and Sorensen's Phosphate Buffer. Full dose of AFLQ compromised of 200 microgram 3D-PHAD and 100 microgram QS-21, co-administered with main intervention. | Drug | Group 1B, Group 2B, Group 3B |
| CJCV2Vaccine comprised of C. jejuni capsule conjugated to Cross-Reactive Material 197 (CRM197), a non-toxic mutant protein of diphtheria toxin. CJCV2 will be reconstituted in 1 mL of sterile water for injection (SWI). The resuspended CJCV2 product will be diluted with sterile 0.9% Sodium Chloride for Injection. 3 dosages for administration: 1 microgram, 3 micrograms, and 10 micrograms. | Biological | Group 1A, Group 1B, Group 2A, Group 2B, Group 3A, Group 3B |
Primary outcome
Number and Percentage of Participants With Solicited Local Adverse Events (AEs) Through 7 Days After Each Study Vaccination
Time frame: Days 1 through 8, Days 29 through 36, and Days 57 through 64
Solicited local AEs were collected 30 minutes post-vaccination, and then daily for 7 days after each vaccination using a memory aid and graded on a scale of 0 (none), 1 (mild), 2 (moderate) and 3 (severe). Local symptoms included ecchymosis, ecchymosis (measurement), erythema, erythema (measurement), induration/edema, induration/edema (measurement), pain, and tenderness.
Number and Percentage of Participants With Solicited Systemic Adverse Events (AEs) Through 7 Days After Each Study Vaccination
Time frame: Days 1 through 8, Days 29 through 36, and Days 57 through 64
Solicited systemic AEs were collected prior to vaccination, 30 minutes post-vaccination, and then daily for 7 days after each vaccination using a memory aid and graded on a scale of 0 (none), 1 (mild), 2 (moderate) and 3 (severe). Systemic symptoms included arthralgia, fatigue, fever, feverishness (chills/shivering/sweating), headache, malaise, myalgia, nausea, and vomiting.
Number and Percentage of Participants With Vaccine-related Unsolicited AEs Through 28 Days Post Last Vaccination
Time frame: Day 1 through Day 85
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, regardless of its causal relationship to the study treatment. The FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. The occurrence of an AE could have come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor. An AE was considered related if there was a reasonable possibility that the study product caused the AE. Reasonable possibility means that there was evidence to suggest a causal relationship between the study product and the AE.
Number and Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: Day 1 through Day 420
An AE or suspected adverse reaction was considered a SAE if, in the view of either the PI or sponsor, it resulted in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not have resulted in these outcomes could be considered serious when, based upon appropriate medical judgment, they could have jeopardized the participant and could have required medical or surgical intervention to prevent one of the outcomes listed in this definition.
Number and Percentage of Participants With Medically Attended Adverse Events (MAAEs) From First Study Vaccination Through End of Study Participation
Time frame: Day 1 through Day 420
Medically attended adverse events (MAAEs) are any unsolicited AE for which a participant received medical attention, defined as hospitalization, an ER visit, or an otherwise unscheduled visit to or from medical personnel.
Number and Percentage of Participants With New-onset Chronic Medical Conditions (NOCMCs) From First Study Vaccination Through End of Study Participation
Time frame: Day 1 through Day 420
New-onset chronic medical conditions (NOCMCs) are defined as any new ICD-10 diagnosis that is applied to the participant during the duration of the study, after receipt of the study product, that is expected to continue for at least 3 months and requires continued health care intervention.
Number and Percentage of Participants With Potentially Immune-mediated Medical Conditions (PIMMCs) From First Study Vaccination Through End of Study Participation
Time frame: Day 1 through Day 420
Potentially immune-mediated medical conditions (PIMMCs) constitute a group of AEs that includes diseases which are clearly autoimmune in etiology and other inflammatory and/or neurologic disorders which may or may not have autoimmune etiologies.
3 secondary outcomes
Percentage of Participants With >= 4-fold Rise From Baseline in C. Jejuni Capsule-specific Immunoglobulin G (IgG) Serum Antibodies
Time frame: Days 8, 29, 36, 57, 64, 85, and 113
Peak Fold Rise From Baseline in C. Jejuni Capsule-specific Immunoglobulin G (IgG) Serum Antibody Titer
Time frame: Day 8 through Day 113
Maximum C. Jejuni Capsule-specific Immunoglobulin G (IgG) Serum Antibody Titer
Time frame: Day 8 through Day 113
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALFQ and CJCV2 in people with Campylobacter Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 17 inclusion and 28 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 30 Jan 2026). 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?
Number and Percentage of Participants With Solicited Local Adverse Events (AEs) Through 7 Days After Each Study Vaccination (time frame: Days 1 through 8, Days 29 through 36, and Days 57 through 64). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.