Clinical trial · Interventional
Cytomegalovirus Vaccine in Healthy Participants
A Phase I Dose Escalation Study of Lipopeptide Vaccines With Activity Against Human Cytomegalovirus
NCT00712634CI-TRIAL-00002913completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Vaccines may help the body build an effective immune response against cytomegalovirus. PURPOSE: This randomized phase I trial is studying the side effects and best dose of cytomegalovirus vaccine in healthy participants.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Precancerous/Nonmalignant Condition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CMVpp65-A*0201 peptide vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CMV-seropositive participants
- description
- Participants are randomized to receive 1 of 4 escalating doses of CMVpp65-A\*0201 peptide vaccine containing either helper T-lymphocyte (HTL) PADRE peptide or HTL tetanus toxoid peptide. Within each vaccine dose group, two participants are randomized to receive a placebo. Participants receive the vaccine or a placebo subcutaneously (SC) on days 0 and 28 in the absence of unacceptable toxicity.
- interventionNames
- Biological: CMVpp65-A*0201 peptide vaccine
- type
- EXPERIMENTAL
- label
- CMV-seronegative participants
- description
- Participants are randomized to receive 1 of 4 established doses (established in CMV-seropositive participants) of CMVpp65-A\*0201 peptide vaccine containing either HTL PADRE peptide or HTL tetanus toxoid peptide. Participants receive the vaccine on days 0, 28, and 56 in the absence of unacceptable toxicity. Participants with a partial or low-level immune response receive one additional booster vaccine on day 90.
- interventionNames
- Biological: CMVpp65-A*0201 peptide vaccine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Healthy participant * Cytomegalovirus seropositive or seronegative * HLA-A\*0201-positive PATIENT CHARACTERISTICS: * CBC within 1.5 times normal * SMA-18 within 1.5 times normal * Hepatitis B virus antigen seronegative * Hepatitis C virus seronegative * No diagnosis that is associated with immunodeficiency, including HIV infection * No serious abnormalities by EKG (in participants ≥ 50 years of age) * Not pregnant PRIOR CONCURRENT THERAPY: * More than 6 months since prior surgery * No concurrent daily medications for chronic or current illness, except for the following: * Thyroid replacement therapy * Estrogen replacement therapy * Dietary vitamins and protein supplements * Antihistamine medication * Anticholesterol medication * Cardiac and antihypertensive medication * Any medication, as determined by the principal investigator, that is not known or likely to be immunosuppressive
References
Publications (0)
Data not yet available
No reference posted for this study.