CJCV2 Vaccine for Campylobacteriosis

No longer recruiting at 1 trial location

Overseen By Robert W. Frenck

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: IBD, Immunodeficiency, Autoimmune disorders, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, CJCV2, designed to protect against campylobacteriosis, a bacterial infection that causes diarrhea and stomach cramps. Researchers aim to determine if different doses of the vaccine are safe and whether adding an adjuvant (a substance that boosts the vaccine's effect) enhances its efficacy. Generally healthy individuals who have not had a Campylobacter infection in the past three years and are not involved in certain medical treatments or trials may be suitable for this study. As a Phase 1 trial, participants will be among the first to receive this new vaccine, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications, like immunosuppressive therapies and corticosteroids, may affect your eligibility. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the CJCV2 vaccine, both alone and with the helper ingredient ALFQ, has been safe in earlier studies. Initial trials found that participants tolerated the vaccine well, with no major safety concerns, meaning most did not experience serious problems with the treatment.

ALFQ, the helper ingredient used with CJCV2, has also been tested in different vaccines and is known to be safe. Past trials have found similar ingredients to ALFQ safe and effective in enhancing the body's response to vaccines without causing harm.

In summary, both the CJCV2 vaccine and the ALFQ helper ingredient have demonstrated safety in human studies. This information may reassure potential trial participants about the safety of these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for campylobacteriosis focus on managing symptoms or using antibiotics to fight the bacteria. However, CJCV2 is unique because it targets the bacteria directly using a conjugate vaccine approach, which could provide immunity rather than just treating symptoms. Researchers are excited about CJCV2 because it incorporates an Army Liposome Formulation with QS-21 (ALFQ), potentially enhancing the immune response. Furthermore, it offers different dosage variations, allowing for flexibility in optimizing effectiveness and safety.

What evidence suggests that this trial's treatments could be effective for campylobacteriosis?

Research has shown that the CJCV2 vaccine yields promising results in reducing Campylobacter jejuni, a major cause of bacterial diarrhea. A previous study found that this vaccine could protect against diarrhea caused by Campylobacter in a natural setting. In this trial, participants will receive different doses of the CJCV2 vaccine, with some groups also receiving the ALFQ adjuvant (a substance that boosts the immune system) alongside CJCV2. The use of the ALFQ adjuvant has strengthened the vaccine's ability to help the body defend itself, suggesting that the combination might enhance the vaccine's effectiveness. While more information from human trials is needed, these early findings encourage those considering joining a clinical trial for this treatment. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-50 who can consent to study procedures, are not pregnant or breastfeeding, have a BMI under 40, and agree to use contraception. They must be in good health with stable blood pressure and temperature, not on certain medications or drugs, and without recent vaccinations or immunizations.

Inclusion Criteria

Oral temperature is less than 100.4 degrees F

Pulse is 50 to 100 beats per minute (bpm), inclusive

In general, good health* to be safely enrolled in this study as determined by medical history, medication use**, and physical exam

Exclusion Criteria

Positive Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCVs)

I have a history of inflammatory bowel disease.

Have abnormal screening laboratory values within 30 days prior to enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intramuscular vaccinations of CJCV2 with or without ALFQ, spaced 28 days apart

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ALFQ
• CJCV2

Trial Overview The trial tests the safety and immune response of three doses (1 ug, 3 ug, and 10 ug) of CJCV2 vaccine against Campylobacter jejuni infection. It's given with/without ALFQ adjuvant over three intramuscular shots spaced by 28 days. Participants are grouped into cohorts to compare different dosages.

How Is the Trial Designed?

Group I: Group 3B Experimental Treatment 2 Interventions

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

Group II: Group 3A Experimental Treatment 1 Intervention

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

Group III: Group 2B Experimental Treatment 2 Interventions

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

Group IV: Group 2A Experimental Treatment 1 Intervention

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

Group V: Group 1B Experimental Treatment 2 Interventions

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

Group VI: Group 1A Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6495334/

Enhanced Immunogenicity and Protective Efficacy of a ... Here, we report enhanced immunogenicity of the conjugate vaccine delivered with liposome adjuvants containing monophosphoryl lipid A without or ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05500417?term=AREA%5BBasicSearch%5D(ALFQ%20vaccine%20adjuvant)&rank=4

Safety and Immunogenicity of CJCV2 With and Without ALFQ ALFQ (Army Liposome Formulation containing QS-21) is composed of ALF55 (cGMP-manufactured Army Liposome Formulation), QS-21 (purified extracted saponin), and ...

3. journals.asm.org journals.asm.org/doi/abs/10.1128/mSphere.00101-19

Enhanced Immunogenicity and Protective Efficacy of a ... Here, we report enhanced immunogenicity of the conjugate vaccine delivered with liposome adjuvants containing monophosphoryl lipid A without or ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31043512/

Enhanced Immunogenicity and Protective Efficacy of a ... Here, we report enhanced immunogenicity of the conjugate vaccine delivered with liposome adjuvants containing monophosphoryl lipid A without or with QS-21, ...

5. nature.com nature.com/articles/s41598-022-11230-8

Army liposome formulation containing QS-21 render ... We demonstrate that the Army Liposome Formulation containing MPLA, and QS-21 (ALFQ) activated MDM that are normally permissive to HIV-1 infection.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10537867/

QS21-Initiated Fusion of Liposomal Small Unilamellar ... A unique feature of ALFQ is the formation of giant unilamellar vesicles (GUVs) having diameters >1.0 μm, due to a remarkable fusion event.

7. trial.medpath.com trial.medpath.com/clinical-trial/76b5a43c01c2eb98/nct05500417-safety-immunogenicity-campylobacter-jejuni-vaccine

Safety and Immunogenicity of CJCV2 With and Without 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).

8. journals.asm.org journals.asm.org/doi/10.1128/msphere.00101-19

Enhanced Immunogenicity and Protective Efficacy of a ... AS01 is a liposome-based adjuvant formulation containing MPLA and QS-21 that is similar to the liposome adjuvants utilized in this study, specifically ALFQ.

9. tandfonline.com tandfonline.com/doi/full/10.1080/14760584.2020.1745636

Army Liposome Formulation (ALF) family of vaccine ... ALF exhibited safety and strong potency in many vaccine clinical trials. Improvements based on ALF include: ALF adsorbed to aluminum hydroxide (ALFA); ALF ...