A Phase I Study of the Safety and Immunogenicity of ACT-1239, a Vaccine for Plasmodium falciparum Malaria

Artificial Cell Technologies, Inc.0 sites50 target enrollmentJuly 16, 2019

ConditionsMalaria Infection - Other infectious diseases

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Malaria
Sponsor: Artificial Cell Technologies, Inc.
Enrollment: 50
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 16, 2019

End Date

January 16, 2021

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Artificial Cell Technologies, Inc.

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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;