Safety and immunogenicity of ACT-1239 in healthy volunteers
- Conditions
- MalariaInfection - Other infectious diseases
- Registration Number
- ACTRN12619001022156
- Lead Sponsor
- Artificial Cell Technologies, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
•Healthy males and females aged between 18-45 years (inclusive)
•Body mass index (BMI) 18-32 kg/m2 (inclusive);
•Negative test for selected drugs of abuse at screening (does not include alcohol) and prior to enrollment on Day 1;
•Non-pregnant and non-lactating females, and either surgically sterile for a minimum of 6 months, or use highly effective contraceptive method (oral contraceptives pills, long-acting implantable hormones, injectable hormones, a vaginal ring or an intrauterine device [IUD]) from screening until at least 3 months after the last vaccination with ACT-1239, or be post-menopausal for greater then or equal to 12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels (greater than or equal to 40 IU/mL) at screening for amenorrhoeic female participants. Females who are abstinent from heterosexual intercourse will also be eligible;
•Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening and on Day 1 prior to enrollment and be willing to have additional pregnancy tests as required throughout the study;
•Surgically sterile males, or if engaged in sexual relations with a WOCBP, the participant and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from screening for at least 3 months after the last vaccination with ACT-1239. Acceptable methods of contraception include the use of condoms and the use of an effective contraceptive for the female partner (WOCBP) that includes: OCPs, long acting implantable hormones, injectable hormones, a vaginal ring or an IUD. Male participants whose female partner is post-menopausal, and participants who are abstinent from heterosexual intercourse will also be eligible. Male participants must agree to refrain from donating sperm from screening for at least 3 months after the last vaccination with ACT-1239;
•No plans to travel to a malaria endemic area over the study duration
•Pregnant or lactating females at screening or plans to become pregnant or breastfeed from the time of enrollment until 3 months after the last vaccination;
•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, rheumatologic, psychiatric, or neurologic disorders (including seizure disorder and chronic migraine headaches);
•History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past five years, regardless of whether there is evidence of local recurrence or metastases;
•Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational vaccine administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the participant inappropriate for entry into this study;
•History of severe allergy (requiring hospital care), severe reaction to any drug or prior vaccination, or any known or suspected allergies or sensitivities to any component of the investigational vaccine;
•Immunosuppression caused by disease;
•History of autoimmune disorder;
•Seropositive for HIV or Hepatitis C Virus or Hepatitis B surface antigen (HBsAg) positive;
•History of splenectomy or of condition affecting splenic function;
•Significant infection or other acute illness, including fever over 37.5°C on the day of enrollment;
•Birthmarks, tattoos, wound or other skin conditions over the deltoid region of both arms that, in the Investigator’s opinion, could reasonably obscure and interfere with evaluation of local injection site reactions;
•Thrombocytopenia or bleeding disorder contraindicating IM vaccination;
•Inadequate venous access to allow collection of blood samples;
•Receipt of immunoglobulins or blood products within 3 months of first vaccination or any planned administration during the study period;
•Use of immunosuppressive or other immune-modifying drugs within six months of vaccination and for the study duration (inhaled and topical steroids are permitted);
•Use of prescription or non-prescription drugs, and herbal supplements within 14 days or 5 half-lives (whichever is the longer) prior to the first vaccination. As an exception, ibuprofen (preferred) may be used at doses of up to 800 mg/day, or paracetamol at doses up to 4 g/day may be used for minor ailments during the course of the study, at the Investigator’s discretion, without prior consultation with the Sponsor’s MM. Paracetamol and ibuprofen may be used for treatment of AEs occurring after vaccination, but should not be administered prophylactically for such events, as such use may mask reactogenicity and interfere with immune responses. Limited use of other non-prescription medications or vitamins not believed to affect participant safety, or the overall results of the study may be permitted on a case-by-case basis following approval by the Sponsor in consultation with the Investigator;
•Receipt of any licensed vaccine within 30 days prior to first vaccination or before the 6 month follow up visit (6 months following last administered vaccination);
•Use of any investigational or non-registered drug or vaccine within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study vaccine or planned use during the study period;
•Any h
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety of escalating doses of ACT-1239 administered intramuscularly (IM) to healthy malaria naïve participants according to a repeat vaccination schedule (at Day 1, Day 29 and Day 57)[Assessment of AEs/SAEs, recording concomitant medications, physical exams, obtaining vitals and collection of blood and urine samples. On-site assessments to occur on Days 1, 3, 15, 29, 31, 43, 57, 59, 71, 85 and 6 months and 12 months after final vaccination. With telephone calls on Days 2, 8, 30, 36, 58 and 64 to asses AEs/SAEs and concomitant medications.];Immunogenicity outcome is assessed using the following assays:<br>ELISA and ELISPOT assays. With on-site samples drawn on Days 1, 15, 29, 43, 57, 71 and 6 months and 12 months after final vaccination. <br>[Immunogenicity outcome is assessed using the following assays:<br>ELISA and ELISPOT assays. With on-site samples drawn on Days 1, 15, 29, 43, 57, 71 and 6 months and 12 months after final vaccination.<br>]
- Secondary Outcome Measures
Name Time Method To determine the humoral response to the T1B peptide, in terms of peptide-specific antibody titers (as measured by ELISA) and functionality (hepatocyte invasion assay [HIA]) in whole blood. This is a composite secondary outcome and correctly captured as one outcome. [Day 1, Day 15, Day 29, Day 43, Day 57, Day 71, Month 6 and Month 12 ];Exploratory analysis of biomarkers of cellular responses to vaccination, as measured by enzyme linked immunospot (ELISPOT) of whole blood samples. [Day 1, Day 15, Day 29, Day 43, Day 57, Day 71, Month 6 and Month 12 ]