CompletedPhase 1

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

Canada128 participantsStarted 2016-06-23

Plain-language summary

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

Who can participate

Age range18 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Generally healthy adult female and male 18 to 40 years of age, inclusive;
✓. Serologically confirmed to be CMV seronegative at screening;
✓. Female volunteers must agree to use an adequate contraception method as deemed appropriate by the investigator
✓. 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

✕. 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
✕. 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
✕. Previous receipt of any cytomegalovirus vaccine
✕. History of allergic reactions or anaphylactic reaction to any vaccine component
✕. Pregnant or breastfeeding or plans to conceive from two weeks before the study start through six months after the last dose of study vaccine
✕. Known or suspected impairment of immunological function, including but not limited to autoimmune diseases, splenectomy, or HIV/AIDS
✕. 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
✕. 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

What they're measuring

Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period

Timeframe: Day of vaccine administration (days 0, 56, 168) and six subsequent days

Number of Participants With Any Adverse Event

Timeframe: Following each of the 3 injections of study vaccine, the occurrence of adverse events was captured during a 28-day follow-up period as well as through Day 336 or early withdrawal.

Number of Participants With Any Serious Adverse Event

Timeframe: Through Day 336 or early withdrawal

Number of Participants With Any Hematological or Biochemical Laboratory Abnormality

Timeframe: Through Day 336 or early withdrawal

Trial details

NCT IDNCT02826798

SponsorVBI Vaccines Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-09-15

Results submitted2019-06-13

View on ClinicalTrials.gov More Cytomegalovirus Infections trials

Who can participate

Age range18 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Generally healthy adult female and male 18 to 40 years of age, inclusive;
✓. Serologically confirmed to be CMV seronegative at screening;
✓. Female volunteers must agree to use an adequate contraception method as deemed appropriate by the investigator
✓. 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

✕. 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
✕. 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
✕. Previous receipt of any cytomegalovirus vaccine
✕. History of allergic reactions or anaphylactic reaction to any vaccine component
✕. Pregnant or breastfeeding or plans to conceive from two weeks before the study start through six months after the last dose of study vaccine
✕. Known or suspected impairment of immunological function, including but not limited to autoimmune diseases, splenectomy, or HIV/AIDS
✕. 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
✕. 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

What they're measuring

Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period

Timeframe: Day of vaccine administration (days 0, 56, 168) and six subsequent days

Number of Participants With Any Adverse Event

Timeframe: Following each of the 3 injections of study vaccine, the occurrence of adverse events was captured during a 28-day follow-up period as well as through Day 336 or early withdrawal.

Number of Participants With Any Serious Adverse Event

Timeframe: Through Day 336 or early withdrawal

Number of Participants With Any Hematological or Biochemical Laboratory Abnormality

Timeframe: Through Day 336 or early withdrawal