Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vaccine in Healthy Adults

VBI Vaccines

Status and phase: Completed; Phase 1

Conditions: Cytomegalovirus Infections

Treatments: Drug: Placebo; Drug: VBI-1501A 1.0 μg; Drug: VBI-1501A 0.5 μg; Drug: VBI-1501 1.0 μg; Drug: VBI-1501A 2.0 μg

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02826798

VBI-1501

Details and patient eligibility

About

The purpose of this study is to compare the safety and effectiveness of four different doses of cytomegalovirus vaccines in healthy adults.

Full description

This study is designed to assess safety and immunogenicity of four dose formulations of cytomegalovirus (CMV) vaccine (0.5 μg gB content with aluminum phosphate (alum), 1.0 μg glycoprotein B (gB) content with alum, 2.0 μg gB content with alum, or 1.0 μg gB content (without alum) as compared with placebo in approximately 125 healthy CMV-seronegative volunteer participants between 18 and 40 years of age.

Enrollment: 128 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Generally healthy adult female and male 18 to 40 years of age, inclusive;
2. Serologically confirmed to be CMV seronegative at screening;
3. Female volunteers must agree to use an adequate contraception method as deemed appropriate by the investigator
4. Sign an informed consent document indicating understanding of the purpose and procedures required for the study and willingness to participate in the study

Exclusion criteria

1. History of or current clinically significant medical illness or any other illness that in the opinion of the investigator interferes with the interpretation of the study results
2. Clinically significant abnormal physical examination, vital signs, or clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening as determined by the investigator
3. Previous receipt of any cytomegalovirus vaccine
4. History of allergic reactions or anaphylactic reaction to any vaccine component
5. Pregnant or breastfeeding or plans to conceive from two weeks before the study start through six months after the last dose of study vaccine
6. Known or suspected impairment of immunological function, including but not limited to autoimmune diseases, splenectomy, or HIV/AIDS
7. Chronic administration (defined as more than 14 days in total) of immune-suppressive or other immune-modifying drug with six months prior to the product dose (for corticosteroids, this is defined as prednisone ≥20 mg/day or equivalent). Inhaled and topical steroids are allowed
8. Participation in another clinical study within 30 days or plans to participate in another treatment based clinical study during the conduct of the present study
9. Any skin abnormality or tattoo that would limit post-vaccination injection site assessment
10. Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease
11. Are family members of study center staff

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 5 patient groups, including a placebo group

VBI-1501A: 0.5µg with adjuvant

Experimental group

Description:

0.5µg CMV vaccine with adjuvant

Treatment:

Drug: VBI-1501A 0.5 μg

VBI-1501A: 1.0µg with adjuvant

Experimental group

Description:

1.0µg CMV vaccine with adjuvant

Treatment:

Drug: VBI-1501A 1.0 μg

VBI-1501A: 2.0 µg with adjuvant

Experimental group

Description:

2.0 µg CMV vaccine with adjuvant

Treatment:

Drug: VBI-1501A 2.0 μg

VBI-1501: 1.0µg without adjuvant

Experimental group

Description:

1.0µg CMV vaccine without adjuvant

Treatment:

Drug: VBI-1501 1.0 μg

Placebo

Placebo Comparator group

Description:

Buffer/sucrose used for VBI-1501 suspension

Treatment:

Drug: Placebo