Zika-Vaccine Dose Finding Study Regarding Safety, Immunogenicity and Tolerability (V186-001)

Themis Bioscience

Status and phase: Completed; Phase 1

Conditions: Zika Virus

Treatments: Other: Placebo; Biological: MV-ZIKA

Study type: Interventional

Funder types: Industry

Identifiers

NCT02996890

V186-001

MV-ZIKA-101 (Other Identifier)

2016-004212-34 (EudraCT Number)

Details and patient eligibility

About

Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in 48 healthy volunteer subjects.

After completion of screening procedures, the subjects are randomized to one of four treatment groups (different dosage strengths and placebo) All subjects will receive study treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with two vaccinations will receive a second treatment at day 28.

Subjects will return on day 56 for the final visit.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers aged 18 to 55
• subjects of child bearing potential must perform reliable method of contraception

Exclusion criteria

• immune deficiency, history of HIV, HBV, HCV
• drug addiction
• vaccination within 4 weeks prior to study or planned vaccination during study
• prior receipt of any Zika vaccine
• recent infection 1 week prior to screening
• relevant medical history interfering with aim of study
• neoplastic disease, hematological malignancy
• history of autoimmune disease
• psychological condition that affects ability to participate in the study
• history of severe adverse reactions to vaccine administration
• history of anaphylaxis
• allergic reactions, abnormal lab values, or concomitant medication per decision of the investigator
• use of immunosuppressive drugs within 30 days before screening or planned use during study
• receipt of blood products within 120 days before screening or planned use during study
• pregnancy, unreliable contraception method
• decision of the investigator
• regular blood plasma donor

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 4 patient groups, including a placebo group

High dose - single shot

Experimental group

Description:

MV-ZIKA, high dose, one vaccination, day 0

Treatment:

Other: Placebo

Biological: MV-ZIKA

Low dose

Experimental group

Description:

MV-ZIKA, low dose, two vaccinations, day 0 and day 28

Treatment:

Biological: MV-ZIKA

High dose

Experimental group

Description:

MV-ZIKA, high dose, two vaccinations, day 0 and day 28

Treatment:

Biological: MV-ZIKA

Placebo

Placebo Comparator group

Description:

Physiological saline, two treatments

Treatment:

Other: Placebo