CJCV2 Vaccine for Campylobacteriosis

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

59 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+