Phase 1
N=190
Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001)
Cytomegalovirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT01986010 ↗Enrolled (actual)
190
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Percentage of Participants With an Adverse Event (AE) — 75.0; 92.9; 84.6; 100.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- V160 Low Dose IM (Biological); V160 Medium Dose IM (Biological); V160 High Dose IM (Biological); V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM (Biological); V160 High Dose plus MAPA 225 µg /dose IM (Biological); V160 Maximum Dose IM (Biological); Placebo IM (Other); V160 Medium Dose ID (Biological); Placebo ID (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Adverse Event (AE) |
75.0; 92.9; 84.6; 100.0; 100.0; 57.9 | — |
| PRIMARY Percentage of Participants With an Injection-site AE |
58.3; 85.7; 69.2; 80.0; 100.0; 26.3 | — |
| PRIMARY Percentage of Participants With a Systemic AE |
66.7; 64.3; 69.2; 90.0; 90.9; 57.9 | — |
| PRIMARY Percentage of Participants With a Serious Adverse Event (SAE) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With a Serious Vaccine-Related Adverse Event |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Treatment Due to an AE |
0; 7.1; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Events of Clinical Interest (ECI) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 |
3301; 4177; 7740; 5701; 3535; 8601 | <0.001 sig |
| SECONDARY Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma |
819; 419; 1384; 1105; 1206; 1080 | — |
| SECONDARY Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides |
168; 193; 79; 86; 211; 64 | — |
| SECONDARY Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 |
3124; 5186; 6232; 6695; 3831; 9127 | — |
Summary
This study will evaluate the safety, tolerability, and immunogenicity of various doses, formulations, and routes of administration of Human Cytomegalovirus (HCMV) vaccine V160 administered in a 3-dose regimen in healthy adults. The initial treatment arm of HCMV seropositive participants will receive V160 Low Dose without adjuvant by intramuscular injection. Escalation of the V160 dose, inclusion of adjuvant, administration by intradermal injection, and vaccination of HCMV seronegative participants will be performed only after review of safety data of previous treatment arms. The purpose of the study is to identify vaccine formulations associated with optimal safety profile and HCMV-specific immune response for evaluation in subsequent clinical studies of V160.
Eligibility Criteria
Inclusion Criteria
- Healthy based on medical history and physical examination
- Serologically confirmed to be HCMV seronegative or HCMV seropositive
- Agrees to avoid unusual, unaccustomed strenuous, vigorous physical exercise/activity from 72 hours before through 72 hours after each dose of study vaccine
- Body weight ≥110 lbs (50 kg) and body mass index (BMI) of 19 to 32 kg/m^2
- If of reproductive potential, agrees to the following during the study and for 4 weeks after the last dose of study vaccine: 1) practice abstinence from heterosexual activity, or 2) use or have their partner use 2 allowable methods of birth control during heterosexual activity
Exclusion Criteria
- Has previously received any cytomegalovirus vaccine
- Has history of allergic reaction or anaphylactic reaction to any vaccine component that required medical intervention
- Has history of any severe allergic reaction that required medical intervention
- Is pregnant or breastfeeding or expecting to conceive from 2 weeks before the study through 1 month after the last dose of study vaccine
- Plans to donate eggs or sperm from study start through 1 month after the last dose of study drug
- Has impairment of immunologic function including, but not limited to autoimmune disease, splenectomy, or human immunodeficiency virus acquired immunodeficiency syndrome (HIV/AIDS)
- Received systemic corticosteroids for ≥14 consecutive days and has not completed treatment within 30 days of study start
- Received immunosuppressive therapy including, but not limited to rapamycin and equivalents, tacrolimus, FK-506, fujimycin, or other therapies used for solid organ/cell transplant, radiation therapy, immunosuppressive/cytotoxic chemotherapy, or other therapy known to interfere with the immune response within 1 year of study start
- Has a condition in which repeated venipuncture or injections pose more than minimal risk, such as hemophilia, thrombocytopenia or other severe coagulation disorders, or significantly impaired venous access
- Has a condition that requires active medical intervention or monitoring such as diabetes mellitus, autoimmune disease, or a clinically significant chronic medical condition that is considered progressive
- Has history within the past 5 years or current drug or alcohol abuse
- Has major psychiatric illness
- Is legally or mentally incapacitated
- Has participated in another clinical study in the past 4 weeks, or plans during the present study to participate in a treatment-based study or a study in which an invasive procedure is performed
- Has received valganciclovir, ganciclovir, valacyclovir, foscarnet, or cidofovir from 4 weeks prior to 1 month following each V160 vaccination
Data sourced from ClinicalTrials.gov (NCT01986010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.